summary 2024 10 23 24 508

MEETING OF THE ADVISORY
COMMITTEE ON IMMUNIZATION
PRACTICES (ACIP)
OCTOBER 23-24 , 202 4
MEETING SUMMARY
Trade names are used for identification purposes only and do not indicate endorsement.

 WEDNESDAY : OCTOBER 23, 2024
WELCOME AND INTRODUCTIONS
Call to Order/Roll Call
Dr. Melinda Wharton (ACIP Executive Secretary) called the October 23, 2024, Advisory
Committee on Immunization Practices (ACIP) meeting to order. She made opening
announcements about the availability of presentation slides on the ACIP website, scheduled
oral public sessions, and the written public comment process. She reviewed conflict of interest
policies for ACIP members. She welcomed and introduced the new committee members: Dr.
Edwin Asturias, Dr. Noel Brewer, Dr. Lin Chen, Dr. Helen Chu, Dr. Mini Kamboj, Dr. George Kuchel, and Ms. Charlotte Moser. She then conducted a roll call, which established a quorum . A
list of Members, Ex Officios , and Liaison Representatives is included in the appendixes at the
end of this summary document. No COIs were identified for the first day of this meeting.  Dr. Bonnie Maldonado disclosed that she previously served as a Data Safety Monitoring Board
member for Pfizer ’s meningococcal vaccine trial s and as a site Principa l Investigator for Pfizer’s
pediatric COVID and maternal respiratory syncytial virus vaccine trials as well as AstraZeneca’s
varicella zoster vaccine trial.
PNEUMOCOCCAL VACCINES
Dr. Jamie Loehr, Chair of the ACIP Pneumococcal Vaccines Work Group, introduced the
pneumococcal vaccines session. He pointed out that PCV21 is not PCV20 plus one additional
serotype; PCV21 includes serotypes not included in previous pneumococcal vaccines and is
missing other serotypes previously included in earlier pneumococcal vaccines. Serotype 4 is not
in PCV21 and may be relevant to specific populations. PCV20 included serotypes accounting
for 54% of cases of invasive pneumococcal disease (IPD) among adults 65 years of age and
older during the period 2018-2022, while PCV21 included serotypes accounting for 85% of
cases .
There are several Pneumococcal vaccines in advanced stages of development.
• 24-valent pneumococcal vaccines (Pn-MAPS24v, GSK; VAX- 24, Vaxcyte)
• 31-valent pneumococcal vaccine (VAX -31, Vaxcyte)
Adults currently recommended to receive a dose of pneumococcal conjugate vaccine (PCV)
include:
• Adults aged ≥65 years who have not received a PCV
• Adults aged 19– 64 years with certain underlying conditions or risk factors who
have not received a PCV
• Certain adults who have received PCV13 but have not received PCV20
PCV21 was developed to target pneumococcal serotypes that commonly cause disease in
adults.  The manufacturer currently does not have plans to seek an indication for routine PC21
use in infants. However, they will seek an indication for the use of PCV21 in children 2-18 years old with a risk condition for which the re is a Phase 3 trial currently in progress. The work group
does not expect PCV21 to offer similar indirect protection from its additional serotypes that were observed from PCV7 or PCV13 use in children.
2

  In June 2024 the work group agreed that available evidence supports PCV21 use for adults
currently recommended to receive a PCV but could not reach a consensus on whether the age-
based recommendations for PCV21 should be lowered from ≥65 to ≥50 years. Most work group
members believed there was insufficient evidence to support lowering the age-based recommendation for other recommended PCVs, specifically PCV15 and PCV20.
At the June ACIP meeting, the committee requested that the work group come back to the committee with a summary of data on whether the recommended age should be lowered to ≥50
years for all PCVs (not just PCV21) at today’s meeting, as the committee felt that there was not
enough data to decide on PCVs other than PCV21 at that time. Another request was to s hare
data on the possible consideration of discontinuing the recommendation for PPSV23 in the future.
The initial policy options considered by the work group were
1. Lower the age-based recommendations for all PCVs to age ≥50 years
2. Lower the age-based recommendation for all PCVs to age ≥60 years or age ≥55 years
3. Lower the age-based recommendation to age ≥50 years but only for PCV21
4. Shared clinical decision- making for PCV use for adults aged 50– 64 years who currently
do not have a risk -based vaccine indication
5. Status quo (i.e., age-based at age ≥65 years, risk-based for younger adults)
The final proposal from the work group was to l ower the age-based recommendations for all
PCVs to age ≥50 years . The majority supported this option after a targeted discussion of the
policy question.  An additional dose may be needed in the future to avoid increased
pneumococcal disease burden in older adults . Several key uncertainties remain: indirect effects
from new pediatric pneumococcal vaccines ; the duration of protection from adult vaccination;
and the impact of new higher -valency vaccines for adul ts. Key factors in the work group
proposal were higher pneumococcal disease rates in Black adults, with an earlier peak; many
adults 50-64 years of age already have an indication for risk -based pneumococcal vaccination;
an age-based recommendation is more likely to improve uptake than is a risk -based
recommendation; it will be easier to implement a uniform recommendation across all PCVs ;
PCV21 had a more favorable health economic profile than PCV20, although both would be
expected to improve health outcomes; and the serotype compositions of PCV20 and PCV21 are quite different.
Dr. Charles Stoecker (Tulane University) discussed PCV use's economic analysis and public
health impact for adults aged ≥50 years . The request to the work group was to evaluate the
cost-effectiveness of an age-based recommendation for PCV20 or PCV21 in adults younger
than 65 years of age. The motivation is to get higher vaccine uptake among adults with
underlying risk conditions , by changing from a risk-based to an age-based recommendation.
Additionally, this may lead to higher pneumococcal vaccine uptake among the general
population. The model evaluated the program's cost and savings and look ed at changes in
disease, medical, nonmedical, and work productivity costs. The population wa s a cohort of
about 4 million 50-year -olds. Separate categories were created for immunocompromised
individuals (IC), individuals with chronic medical conditions (CMC), and others or the general
population that are not IC or have CMC.
3

 Moving Strategies and Adding Strategies were used to evaluate the study question. The Moving
Strategies will move the age-based recommendation from 65 to 50 years of age. This will shift
the disease burden from younger adults to older adults, leaving older adults less protected. The Adding Strategies will add a vaccination at age 50 in addition to age 65. This will maintain
protective benefits for older adults from the current age-based recommendation.
The first Moving Strategy the work group evaluated was an intervention of PCV20 at age 50
compared to PCV20 at diagnosis of CMC/IC and PCV20 at age 65 (current recommendation).
The second Moving Strategy was an intervention of PCV20 at age 60 compared to PCV20 at
diagnosis of CMC/IC and PCV20 at age 65 (current recommendation). The first Adding Strategy
evaluated was an intervention of PCV20 at ages 50 and 65 compared to PCV20 at diagnosis of CMC/IC and PCV20 at age 65 (current recommendation). The second Adding Strategy evaluated an intervention of PCV20 at ages 60 and 75 compared to PCV20 at diagnosis of
CMC/IC and PCV20 at age 65 (current recommendation). The above comparisons were
repeated for PCV21.
The PCV20 and PCV21 vaccines are estimated to cost approximately $300, with an additional
$75 for administrative and other costs. Two scenarios will be evaluated for waning. There will be
no waning for the first 5 years in either scenario. The first will wane to 0 by 15 years, and the
second will wane to 0 by 20 years.
The model also includes the impact of herd effects of PCV20 in children. In year 1, the disease
will be reduced by 25%, with 75% of the disease remaining for the serotypes in PV20. In year 6, 85% of adult disease will be gone due to PCV20 in children. In years 7+, there is no fu rther
decline and will maintain 15% remaining disease seen in year 6. Limitations include uncertainty around waning and herd effects and pneumococcal disease trends. Sequelae from IPD were not modeled explicitly, and disruption from changing pneumococcal schedules was not
modeled.
Moving strategies resulted in increased net cases. While lower cases and deaths were seen in
people ages 50-64, increased cases and deaths were seen in adults ≥65 years of age. It does
have a lower cost, and these results hold under longer vaccine-waning scenarios and scenarios without herd immunity from the childhood program.
Adding a second age-based vaccination increased the cost per quality -adjusted life year ( QALY )
compared with current recommendations. The incremental cost-effectiveness ratio s (ICERs )
ranged from $50k/QALY to $500k/QALY. The ICERs are consistently lower for PCV21
recommendations than that of PCV20. Economic efficiency is improved in PCV20 and PCV21 when no herd effects are included. The changes in $/QALY are more significant in PCV20. However, this change is insufficient to make PCV20 more efficient than PC V21. Assumptions
surrounding vaccine waning are minimally impactful on ICERs because the waning is extended in both the intervention and comparison strategies. Vaccination at later ages is more
economically efficient.
Dr. Andrew Leidner (CDC/NCIRD) summarized three economic analyses on the use of PCVs
among 50-64-year -old adults in the U.S. The main objective of cost-effective analysis (CEA) is
to calculate an ICER. The ICER value is the cost per outcome and summarizes the difference in
value between the two vaccination strategies. The difference in cost of the two strategies is divided by the difference in outcomes to get the ICER. In this case, the two strategies are PCV vaccination intervention at age 50-64, and the comparator is the current set of PCV recommendations.
4

  Economic models of vaccination can be considered calculations that summarize many aspects
of a disease vaccine into a single economic value. The economic model inputs include vaccine
efficacy, disease burden, fatality rates, and cost s. These factors contribute to the estimated
ICER. If the underlying factors are uncertain, the estimated ICER can have a range to reflect
that uncertainty.
As a reminder, the policy question being considered by these models is “Should a single dose of
PCV be recommended for all PCV -naïve adults aged 50-64 years?”
Among the “Moving” comparisons in the models, the intervention is age-based vaccination at
age 50, and the comparator is current recommendations for PCV. In this comparison, the
intervention increases PCV coverage among 50-64-year -olds and reduces coverage among
adults ≥ 65 years of age. The results from the Tulane-CDC and Pfizer models indicated that this
comparison would likely increase the burden of disease overall and shift the burden of disease from adults in their 50s to older adults in their 60s and 70s. There was an increased number of cases, hospitalizations, and deaths. Also note that in this “moving” comparison, the intervention
has 0% vaccination coverage for adults ≥65.
Among the “Adding” comparisons in the models, the intervention is age-based vaccination at
ages 50 and 65 years , and the comparator is current recommendations for PCV. The “Adding”
comparison allows for a more direct estimate of the impacts of expanding coverage to adults
aged 50-64. This comparison also presumes that older adults (65 and up) would not be left
without disease protection if the age -based recommendation is lowered.
Across the main results of the Tulane-CDC and Merck models, looking at age-based use at age 50 and 65 compared to the current recommendations, the cost per QALY for PCV21 ranged from $130,000 to $430,000. Across the main results of all three models, the cost per QALY for
PCV20 ranged from $56,000 to $880,000 per QALY . Across all available models, there’s a
broader range for PCV20 than for PCV21; this is partially due to 3 models being assessed
PCV20 vs only two models that assessed PCV21; this is also due to the impact of indirect effects, which has a larger impact on PCV20 values than PCV21 values. The Tulane-CDC
ICERs tended to be lower than ICERs from the Merck model and were higher than ICERs from
the Pfizer model. The Tulane-CDC and the Merck models assessed both vaccines; in those
models, PCV21 was less expensive than PCV20.
Scenarios with estimated higher vaccine effectiveness and longer duration of protection (>15 years) had lower costs per QALY. Across the Tulane-CDC and Merck model, for PCV21, the
ICERs range from $117,000 to $200 ,000 per QALY. Across all three models, for PCV20, the
ICERs range from $62,000 to $420,000 per QALY. Note that the lowest estimates for PCV20
were from the Pfizer model. Indirect effects are another highly uncertain and impactful input in these models. In these scenarios, when indirect effect assumptions are reduced, there will be a
more significant disease burden in the adult population; this greater disease burden leads to
better values or lower ICERs across all models.
The work group also considered two other models: the Merck health equity model and the
Pittsburgh model. The Merck team submitted a separate health equity modeling analysis that
used the Atkinson index to quantify inequality across Black and non-Black populations, with and
without 50- to 64-year -old PCV vaccination. Their model concluded that 50- to 64-year -old
vaccination would reduce health inequality (or improve health equity). The Pittsburgh model was summarized in the meeting last June. This model also focused on the value of PCV use among
Black and non-Black population groups, and this model estimated equity benefits associated with 50- to 64-year -old PCV vaccination.
5

  There is substantial uncertainty and limited data available for several key model inputs,
including vaccine effectiveness and duration of protection; indirect effects from pediatric PCV20
use; and the impact on vaccine coverage of the proposed age-based recommendation. Additional limitations include the future epidemiology of serotype 4 and 19F, the impact of supplemental PCV doses, the availability of new higher -valency vaccines in coming years, and
implementation challenges possibly associated with changing the schedule, which were not considered in the models.
In summary, using the “adding” approach, age-based vaccination at 50 years would improve
health but was not cost -saving. Estimated results had a broader range in value for PCV20 than
PCV21 because three models, not just two, assessed PCV20. Finally, in the two models that assessed both vaccines, the estimated costs per QALY were lower for PCV21 than for PCV20.
Dr. Chu inquired why the Pfizer model assumed 36% VE compared to 0% after the waning period and whether there w ere data to support it.
Dr. Leidner replied that t he assumptions made in the models are based on expert opinion. To
clarify, the Tulane-CDC models showed that vaccine effectiveness (VE) declined linearly from
five years to zero by the fifteenth year. In contrast, the Pfizer model exhibited a parabolic
decline, gradually decreasing each year. By year 15, the effectiveness was at 36%, and it
dropped to 0% in year 16.
Dr. Talbot asked which studies used to determine the 15-year duration.
Dr. Kobayashi explained that there are insufficient data to determine the appropriate duration for
the period in question. The decision is based on methodologies used in other studies where
assumptions about duration and protection were necessary. More reliable data will be available
in the future.
Dr. Talbot asked whether any modeling was done based on a 20-year protection period to see if
the model would change.
Dr. Leidner confirmed that all three models varied the duration of protection. The Tulane-CDC and Merk models included a 20-year waning period. When there is a more extended protection period, the ICER s decrease. This decrease is not as large as seen with the herd effects.
Dr. Kobayashi noted that the group explored data from other conjugate vaccines, including meningococcal vaccines. It is essential to recognize that the severity of the diseases can differ, so we cannot automatically apply findings from one vaccine to another. Additionally, studies indicate that the duration of protection provided by meningococcal conjugate vaccines is not
very long, typically waning within ten years. While the dosages given to children differ from
those administered to adults, some pediatric studies have shown a gradual decline in protection
within approximately seven years. Consequently, we assume that the protection period may not
extend significantly beyond this estimate, although we acknowledge the uncertainties.
Dr. Talbot mentioned a group of adults who received the PCV13 vaccine, and it would be
interesting to review the serology data on this group since it has been 10 years.
Dr. Kobayashi confirmed that the group would like to explore this group in the future.
6

  Dr. Shaw inquired whether considerations for post-infection care, like the need for long-term
care, a skilled nursing facility, or increased disability, were considered in the models.
Dr. Leidner confirmed that the Merck model included a disability state following IPD episodes,
and the Pittsburgh model included a disability state following a small percentage of IPD episodes and nonbacteremic pneumonia episodes.
Dr. Miwako Kobayashi (CDC/NCIRD) presented the Evidence to Recommendations (EtR) Framework for the policy question, “Should a single dose of PCV be recommended for all PCV -
naïve adults aged 50-64 years?” The seven EtR domains are public health problem, equity, benefi ts and harms, values, acceptability, resource use and feasibility.
For public health importance, Dr. Kobayashi shared that after PCV13 was recommended for children in 2010, IPD rates decreased in children and older adults through the indirect effects of
PCV13 use in children. Subsequently , the incidence of IPD in adults aged 50-64 years has been
higher than that in children <5 years of age. It’s worth noting that although PCV13 was
recommended for all adults aged 65 years and older in late 2014, this intervention had minimal
population-level impact, leading to the discontinuation of this age-based recommendation in
2019. The IPD mortality rates in adults aged 50– 64 years and 65 years of age and older have
been the highest across all age groups. Over time, the IPD mortality rate in adults ≥65 years
has become closer to that in adults aged 50– 64 years. Nearly 90% of adults ages 50 -64 with
pneumococcal disease had at least one condition that currently qualifies for a risk -based
pneumococcal vaccine indication. Data show that the success of the pediatric pneumococcal
vaccine pro gram increased the relative burden of pneumococcal disease in adults aged 50– 64
years, especially in those with risk conditions. The work g roup agreed that pneumococcal
disease is of public health importance.
Equity was a key consideration among the work g roup. About 32 to 54% of adults aged 50-64
years have a self-reported condition with risk -based pneumococcal vaccine indications with a
broader range across race and ethnicity groups compared with adults ≥65 years of age. When
compared to non-Black adults, Black adults' IPD rates peak at age 55-59 years, with higher
rates in all age groups than are seen among non-Black adults, in whom rates steadily increase
with increasing age. The IPD rates for Black adults aged ≥50 years exceed the average IPD
rate for all adults ≥65 years of age. In a hypothetical scenario that applied the current risk -based
vaccine coverage by race for adults 19- to 64 years and age -based vaccine coverage by race
for adults 65 years of age and older, the rates of non-PCV13- type IPD in American Indian (AI),
Alaska Native (AN), and Black adults remain higher than the population average across all racial groups with either PCV20 or PCV21. Another scenario applied the current vaccine
coverage for adults ≥65 years of age by race to adults ≥50 years of age and current risk -based
vaccine coverage by race to adults 19- to 49 years of age. IPD incidence in AI, AN, and Black
adults decreased more compared with scenario 1 with either PCV20 or PCV21 ; however, the
rate decreased below the population average for Black adults in the PCV21 scenario only. Therefore, racial disparities are expected to remain. The Work Group interpretation was that recommending PCV for all PCV -naïve adults aged 50– 64 years of age would probably increase
health equity.
To inform the benefits and harms domain, the Work Group updated its systematic literature
review to include 6 PCV15 trials, 3 PCV20 trials, and 7 PCV21 trials. Immunogenicity data from
these trials was used to inform the benefit domain. The overall conclusions on immunogenicity remain unchanged. PCV15 met the noninferiority criteria for all serotypes shared with PCV13
7

 while having statistically significantly greater responses to the additional serotypes 22F and 33F.
PCV20 also met the noninferiority criteria for all PCV13 serotypes. Compared to PPSV23,
PCV20 met the noninferiority criteria for six out of seven non-PCV13 serotypes, except serotype
8. PCV21 met the noninferiority criteria when compared to PCV20 for all ten shared serotypes
and had statistically significantly greater response to ten out of eleven serotypes unique to PCV21; the exception was serotype 15C. The work g roup believed that the anticipated benefits
of the intervention were of moderate magnitude. However, it's important to note that data which directly address the outcomes specified in the PICO question are unavailable for these newer
vaccines.
The conclusions from safety data from the PCV clinical trials also remained unchanged. No
vaccine -related serious adverse events were reported for PCV15 and PCV20, but two were
reported among PCV21 recipients. Post-licensure PCV20 safety data showed a potential
Guillain -Barré s yndrome (GBS) signal for PCV20 in the Vaccine Adverse Event Reporting
System ( VAERS ). In an updated analysis of Medicare data through May 2024 conducted by the
FDA, there was a GBS signal in sequential monitoring for the primary definition but not for the alternate definition or when adjusted for positive predictive value; there is significant uncertainty
because of the small number of GBS cases observed.  CDC and FDA will continue to monitor
post-licensure PCV safety. Given the uncertainties, the work group felt that the undesirable
anticipated effects of PCV vaccination were minimal despite the updated PCV20 pos t-licensure
safety data from the FDA. Weighing the desirable and undesirable anticipated effects, the work
group believed that supports a recommendation for PCV for all PCV -naïve adults aged 50 – 64
years compared with the current risk -based recommendation.
For the values domain, the work group was split between “yes” and “probably yes” regarding the
target population's feeling that desirable effects are large relative to undesirable effects. A third of the members responded “don’t know.” Members with experience serving underserved populations wi th many underinsured or self-pay individuals noted that these groups can be
comfortable with pneumococcal vaccines if the benefits are clearly explained. When asked, “Is
there important uncertainty about or variability in how much people value the main outcomes?”
the work g roup’s interpretation was “Probably not important uncertainty or variability.”
The work g roup felt that it is acceptable to recommend PCV for all PCV -naïve adults aged 50–
64 years . This is supported by a presentation on the Merck -funded healthcare provider surveys
at the June ACIP meeting. These findings showed challenges with risk -based vaccine
recommendations and that surveyed providers supported lowering the age-based recommendation to age 50 years .
For resources, the majority of the work g roup responded either “probably yes” or “yes” that PCV
use for PCV -naïve adults aged 50-64 years was a reasonable and efficient allocation of
resources. A minority portion of the members said, “probably no.” Those who said “probably no” expressed concerns about the less favorable economic analysis findings for PCV20 than
PCV21. Some work group members felt that improved vaccination coverage among those with
risk-based pneumococcal vaccine indications could diminish the need for broader age-based vaccination. However, insufficient success of this approach was acknowledged. Some work
group members believed the decision varies when considering projections over the next 15
years.
8

 Dr. Kobayashi shared that the work g roup reached a combined majority of “probably yes” and
“yes” regarding the feasibility of implementing PCV for all PCV -naïve adults aged 50 -60.
Vaccine coverage tends to be lower in younger adults, even with an age-based
recommendation. However, with risk -based indications, pneumococcal vaccine coverage was
disproportionately lower in adults aged 50– 64 years compared with coverage in adults 65 years
of age and older. Some Work Group members believed that age-based recommendations are
generally easier to implement than risk -based and that the lower vaccine coverage in younger
adults is likely due to multiple factors, such as healthcare access, perceived risk of disease, or
benefits from vaccination. W ork g roup members agreed that having a different age-based
recommendation by vaccine product would be more challenging to implement. At the same time,
variability in health insurance coverage might keep PCV20 as the only practical option for some individuals in the short term since PCV21 is new.
Factors supporting lowering the PCV age-based recommendation that the work group
recognized were the following:
• The relatively high burden of pneumococcal disease in adults aged 50– 64 years,
particularly among those with risk conditions
• Potential for improved vaccine uptake through an age-based recommendation
• Potential to reduce pneumococcal disease incidence in demographic groups
experiencing the highest burden
• Projected health benefits from economic models despite increased net costs
The work g roup also identified a number of potential implications for lowering the age-based
recommendations for all PCVs.  There were significant concerns about the cost of lowering the
age recommendation for both PCV20 and PCV21 when considering overall health benefits to
society. Variability in health insurance coverage might keep PCV20 as the only practical option
for some individuals in the short term, given that PCV21 is a newer vaccine, but the Work Group agreed that it would be challenging to implement different age-based recommendations by
vaccine .
The work g roup highlighted several uncertainties that could impact future policy decisions ,
including the duration of protection from a dose of PCV in adults ; the magnitude of the indirect
effects of pediatric PCV15/20 vaccination; and the impact of higher -valency vaccines which are
under development.
Despite these uncertainties and concerns, most of the work group believed that recommending
a single dose of PCV for all PCV -naïve adults aged 50– 64 years would probably result in
desirable consequences outweighing undesirable consequences in most settings. The work group members who disagreed with the recommendation had concerns with the higher
cost/QALY gained for PCV20 compared to PCV21, the uncertainties regarding the impact of
pediatric PCV use, and concerns about the implications of a broad recommendation given that
different serotypes are included in PCV20 and PCV21.
The work group agreed to propose the following policy option:
ACIP recommends a pneumococcal conjugate vaccine for all PCV -naïve adults aged
≥50 years.
9

 Dr. Talbot requested clarification on whether, if we move forward with a recommendation for
adults older than age 50 years , there would be an evaluation of whether a second dose is
required.
Dr. Kobayashi confirmed that there is insufficient evidence to recommend when precisely the
second dose should occur. Therefore, today’s policy option will not include a second dose.
Dr. Schechter asked what vaccination coverage rates were used in the hypothetical scenarios
that were presented and whether they were the same across different race/ethnic groups.  Dr. Kobayashi explained that these analyses used observed vaccine coverage data from the
2021 Behavioral Risk Factor Surveillance System (BRFSS) for age- and risk -based
recommendations for each group. For simplicity, they also assumed that all vaccine-type
diseases would be prevented. Thus, the reduction in disease predicted is due the observed
vaccine coverage by racial group and serotype distribution in each racial group.
Dr. Chu asked for clarification that the recommendation is to move the age recommendation
from 65 to 50 years of age. However, in the “moving” strategy, the disease burden rises from the
younger population to the older, if a second dose is not recommended at age 65.
Dr. Kobayashi responded that if no future vaccination coverage is offered, that is a potential risk.
However, as mentioned during the economic model presentations, it is unlikely that adults will
only have an opportunity to get vaccinated at age 50. If the age-based recommendation is
lowered, adults will likely be vaccinated at older ages. The work g roup also does not know what
recommendations will made in the future for new vaccines that may come. Because of these
uncertainties, the team would like to reevaluate this in the future.
Dr. Chu inquired whether the group had data by race on uninsured 50- to 64-year -olds who
would not be able to receive the PCV21.
Dr. Kobayashi estimated that about 10% of adults in the 50- to 64 year old age group do not
have insurance coverage, and this value decreases in adults 65 years of age and older. These
data are not available for this age group by race.
Dr. Brewer asked whether the vaccine effectiveness remains the same at ages 50 and 65 years
and how the work g roup decided on the vaccination at age 50. He suggested that using an
existing vaccination age from the schedule might complicate vaccinating at that age.
Dr. Kobayashi noted evidence suggesting that vaccine effectiveness may be lower in older
adults than younger adults. The work group considered age thresholds of 55 and 60 but
ultimately selected age 50 because the incidence of IPD is elevated in Black adults beginning at
age 50 years with a peak at 55-59 years. The age of 55 was not chosen since it did not align
with existing vaccination recommendations, which raised concerns about implementation.
Dr. Shaw asked if guidance would be provided to practitioners treating populations with a higher
prevalence of serotype 4 disease since PCV21 does not include this serotype.
Dr. Kobayashi does not have updated data for populations observing a higher prevalence of serotype 4 disease. This guidance is captured in an MMWR published in September 2024. When available, updated data will be shared.
10

 Dr. Asturias asked what proportion of other medical conditions were diagnosed at the time of the
pneumococcal infection.
Dr. Kobayashi stated that this information is unavailable, but people may have gotten sick and
had undiagnosed risk conditions.
Dr. Brooks asked whether data w ere available on the vaccination status of those with risk
factors who were hospitalized with pneumococcal disease in the age group 50- to 64 years.
Dr. Kobayashi responded that vaccination history is not available in these data sources for
individuals with risk conditions but that her team would like to explore this in the future.
Dr. Maldonado commented on the issue of access. Messaging needs improvement for the 50-
to 64-year -old group. Referring to COVID-19 vaccination , individuals with underlying conditions
had difficulty getting documentation to provide to pharmacies for additional off-label doses of
vaccines. She called for action for these groups and studies to see why these individuals are missing vaccinations.
Dr. Loehr clarified that the work g roup did not intend to penalize individuals over age 65 by
recommending the vaccine dose at age 50. If waning immunity is as expected, the work g roup
felt that an additional dose would be needed 15 years after the initial dose. Currently, these data
are unavailable, but this issue will be studied over time. He also mentioned that if there is a high
prevalence of serotype 4 in a community, clear guidance will be provided recommending PCV20
over PCV21 or a vaccination for serotype 4 if any new options become available. He
emphasized that most members of the work g roup favored lowering the age for all PCVs to age
50 for equity reasons. However, Dr. Loehr stated that as an individual ACIP member he
disagrees and believes that only the age recommendation for PCV21 should be reduced to age 50. The work g roup decided to lower the age for all PCVs to simplify the vaccination schedule
for physicians. Dr. Loehr disagrees with this decision due to the differences in cost
effectiveness , as PCV20 has a higher cost per QALY than PCV21 when the age is lowered to
age 50. He believes that PCV21 is a better vaccine because it covers more serotypes. Despite
his personal disagreement, he formally made a motion to recommend that a PCV be
administered to all PCV -naïve adults aged 50 years and older.
Dr. Cineas seconded the motion.
Dr. Talbot commented that vaccinating at age 50 and again at age 65 is a win because it means
adults have had a healthy life and have not passed away before their grandchildren.
Dr. Brewer stated that the implementation argument has not yet persuaded him and that
he cannot support this for PCV20.
Dr. Brooks emphasized that there are seven domains of EtR and questioned whether problems
in just one domain should be sufficient to influence a vote on the proposed policy option. He believes the positives in the other domains outweigh the negatives in the areas of concern.
Dr. Shaw reminded the group that even with the proposal to lower the age-based
recommendation to age 50 for PCV21, an exception will still need to be made for prevention of
serogroup 4 disease in at-risk individuals.
11

 Dr. Loehr confirmed that serogroup 4 will be addressed in clinical considerations. He also
emphasized that there is a difference in how different members’ values are reflected in the
priorit y they place on different EtR domains. He does, however, respect the work g roup’s
decision.
Dr. Jamieson mentioned that, along with cost-effectiveness, another issue is that PCV21
serogroup coverage is better for most adults. It seems that this can be handled in clinical
considerations. This may mean a recommendation for 50 and above, but with clinical
consideration, PCV21 may be better in some cases based on serogroup coverage.
Dr. Zimmerman commented on behalf of the Association for Prevention Teaching and Research,
stating the group was in support of lowering the age of routine vaccination to 50 years due to the benefits on health equity and to better protect individuals with high-risk conditions aged 50-
to 64 years because risk-based recommendations result in lower vaccine coverage than age-
based recommendations. There is a large burden of pneumococcal disease in persons under 65
years of age with high-risk conditions and the highest rates for pneumococcal disease in Black
Americans are seen among those under 65 years of age. A published decision analysis showed
that PCV21 at age 50 and again at age 65 will result in a 15% decrease in IPD cases in Black
Americans and a 14% decrease in other populations.
Dr. Goldman favored lowering the age recommendation for vaccination because it would
improve implementation and benefit the patients. He reiterated that PCV2 1 is very different from
PCV20 . He shared that he is concerned with lowering one, not the other, because
recommendations would differ for those in this age group with and without underlying medical
conditions. It is essential to be concise and clear on who should be vaccinated between 50 and
64, especially among those with other medical conditions.
Dr. Richard Haupt (Merck ) expressed strong support for the recommendation and underscored
the imperative of this vote for improved adult pneumococcal vaccine utilization and, more
importantly, health equity. A vote to expand the age-based recommendation improves access to
the benefits of pneumococcal vaccination. It provides opportunities to reduce persistent disparities in pneumococcal disease risk that current recommendations have not addressed. He also noted that Merck has very high payer coverage from both commercial and Medicare Advantage plans for PCV21, licensed in June. The vast majority have already covered PCV21.
Dr. Luis Jodar ( Pfizer ) stated that despite the different compositions, Pfizer supports the ACIP
recommendation to use any currently available PCVs for all adults ages 50 and older. In the
case of PCV20, this is supported by the burden of IPD and pneumococcal pneumonia caused by the 20 serotypes which remains a public health concern, which is especially important for
serotypes unique to PCV20, including serotype 4, which has been increasing in the U.S. and
globally with a focus on disadvantaged populations. Pfizer recommends the coexistence of both
PCV21 and PCV15 followed by PCV23 and PCV20 in the population, which will allow a greater
choice and less complexity of recommendations and increase equity and improve
implementation.
Dr. Kobayashi then provided an overview of proposed c linical considerations for implementation.
The proposed language is as follows:
A single dose of PCV (PCV15, PCV20, or PCV21) is recommended for all adults aged
≥50 years and for adults aged 19– 49 years with certain underlying conditions or risk
factors* who have not received a PCV or whose vaccination history is unknown.
12

  *Alcoholism; chronic heart, liver, or lung disease; chronic renal failure; cigarette smoking;
cochlear implant; congenital or acquired asplenia; cerebrospinal fluid leak; diabetes mellitus;
generalized malignancy; HIV; Hodgkin disease; immunodeficiency; iatrogenic
immunosuppression; leukemia, lymphoma, or multiple myeloma; nephrotic syndrome; solid organ transplant; sickle cell disease; or other hemoglobinopathies.
For PCV13 -experienced adults who completed the recommended vaccine series, the shared
clinical decision-making recommendation regarding the use of a supplemental PCV20 or PCV21
dose remains unchanged. The current age threshold is maintained because, under previous
recommendations, PCV13-vaccinated adults were only considered to have received all
recommended vaccine doses after receiving one final dose of PPSV23 at or after age 65. The proposed language is as follows:
Shared clinical decision- making is recommended regarding use of a supplemental
PCV20 or PCV21 dose for adults aged ≥65 years who have completed their recommended vaccine series with both PCV13 and PPSV23.
For PCV13 -experienced adults who have not completed the recommended vaccine series, the
proposal is to remove the option to complete the vaccine series with PPSV23 and instead to recommend a single dose of either PCV20 or PCV21.
The proposed language is as follows:
A single dose of either PCV20 or PCV21 is recommended as an option for adults aged
≥19 years who have started their pneumococcal vaccine series with PCV13 but have not
received all recommended pneumococcal vaccine doses.
The team will work to update guidance for populations experiencing serotype 4 disease.
Vote: Pneumococcal Vaccines
The vote occurred later in the day following public comment but is incorporated here for
continuity.
Dr. Keipp Talbot (ACIP Chair ) read the following proposed ACIP voting language for
pneumococcal vaccines into the record:
ACIP recommends a pneumococcal conjugate vaccine (PCV) for all PCV -naïve adults
aged ≥50 years
Motion/Vote: Pneumococcal Vaccines
D
r. Loehr motioned to approve the proposed v ote recommendation for pneumococcal vaccines,
stating, “ ACIP recommends a pneumococcal conjugate vaccine (PCV) for all PCV -naïve adults
aged ≥50 years.” Dr. Cineas seconded the motion. No COIs were declared. The motion carried
with 14 favoring and 1 opposing. The disposition of the vote was as follows:
1
4 Favored: Brooks, Brewer, Maldonado, Kamboj, Cineas, Asturias, Schechter, Jamieson,
C
hu, Moser, Shaw, Chen, Kuchel, Talbot
1 Opposed: Loehr
0 A
bstained:
13

  INFLUENZA VACCINE S
Dr. Jamie Loehr, Chair of the ACIP Influenza Vaccine Work Group, opened the influenza session by announcing that FluMist
® (Live Attenuated Influenza Vaccine) was approved by the
FDA for self-administration or administration by a caregiver on September 20, 2024. This
change is expected to take effect for the 2025-26 influenza season. Currently, FluMist can only be given by a healthcare provider but in the future it will be available for shipment to private homes.
Dr. Sascha Ellington (CDC/NCIRD) presented an update on the 2023-24 end-of-season
influenza vaccine effectiveness. This season was a predominant A(H1N1)pdm09 season with
lower levels of A(H3N2) and B/Victorian circulation. Peak activity occurred in week 52 of 2023.
Vaccines were quadrivalent and included A(H1N1)pdm09, A(H3N2), and B components.
The four CDC VE investigating networks are the Investigating Respiratory Viruses in the Acutely
Ill (IVY), the New Vaccine Surveillance Network (NVSN), the US Flu Vaccine Effectiveness Network (US Flu VE), and the Virtual SARS-CoV-2, Influenza, and Other Respiratory Viruses Network (VISION). The networks include all ages across inpatient and outpatient settings and are geographically diverse, including patients from 23 states.
Dr. Ellington described the methods for estimation of influenza vaccine effectiveness for the
2023-2024 season. Enrollees were people with acute respiratory illness who presented for
medical care. The test- negative design was used to determine VE. Vaccination odds were
compared among case patients with influenza confirmed by molecular assay versus control patients testing negative for influenza and SARS -CoV -2. Persons were classified as vaccinated
based on receipt of any 2023– 24 seasonal flu vaccine according to medical records,
immunization registries, claims data, and/or self-report. VE was calculated as 1 minus the
adjusted odds ratio times 100%.  Estimates were adjusted for geographic region, age, and calendar time of illness. In IVY, US Flu VE, and VISION estimates were also adjusted for sex and race and ethnicity, and the US Flu VE estimates were also adjusted for days between
illness onset and enrollment and self- reported general health status.
The final estimates for VE among children 6 months to 17 years of age against any influenza
ranged from 56% to 59% in outpatient settings and 59% to 64% in the inpatient setting. These
were comparable to the interim estimates that included data through the end of January that were presented at the February 2024 ACIP meeting. The final estimate for VE against influenza
A in the pediatric population ranged from 43% to 50% in outpatient settings and 44% to 51% in the inpatient setting, similar to the interim estimates. The final estimate for VE against influenza B in the pediatric populati on ranged from 64% to 74% in outpatient settings and 78% to 85% in
inpatient settings; the interim estimates were similar in the outpatient setting but data were insufficient for an interim estimate for children in the inpatient setting.
For adults aged 18- to 49 years of age, the final estimate for influenza VE against any influenza
ranged from 37% to 54% in outpatient settings and 51% to 53% in inpatient setting s. The final
estimate in this age group for VE against influenza A ranged from 20% to 45% in outpatient
settings and 37% to 44% in inpatient settings and for influenza B, 67% to 75% in outpatient
settings and 68% to 72% in inpatient settings.
14

  For adults aged 50- to 64 years of age, the final estimate for influenza VE against any influenza
ranged from 22% to 44% in outpatient settings and 40% to 48% in inpatient setting s. The final
estimate in this age group for VE against any influenza A ranged from 11% to 39% in outpatient settings and 38% to 39% in inpatient settings and for influenza B, 81% to 82% in outpatient
settings and 61% to 86% in inpatient settings.
For adults ≥65 years of age, the final estimate for influenza VE against any influenza ranged
from 37% to 40% in outpatient settings and 31% to 36% in inpatient settings . The final estimate
in this age group for VE against any influenza A ranged from 36% to 37% in outpatient settings
and 27% to 35% in inpatient setting s and for influenza B, 67% to 80% in outpatient settings and
39% to 66% in inpatient settings. The three active surveillance networks were used to estimate the VE against subtypes of
influenza A. For A(H1N1), all estimates were under 50% for adults, with the lowest VE observed
in adults <65 years of age. VE was about 50% from NVSN in inpatient and outpatient settings
for children. The US Flu network estimated 60% VE for children in outpatient settings.
Because it was a predominantly an A(H1N1) season, less data were available for A(H3N2),
resulting in wider confidence intervals. The lowest VE was among adults ≥65 years old. For
children, VE was around 40% against hospitalization and 50% against outpatient influenza from
NVSN. The US Flu network estimated lower VE for children in outpatient settings.
Dr. Ellington concluded that vaccination with a 2023– 2024 influenza vaccine reduced the risk of
medically attended influenza outpatient visits and hospitalizations among children, adolescents,
adults, and adults over age 65 years. Most results were consistent across all four networks and
these end-of -season estimates were similar to interim estimates from February.
Dr. Tom Shimabukuro (CDC/NCIRD) provided an update on Highly Pathogenic Avian Influenza
A (H5N1). A substantial number of cases in 2024 were reported in the U.S. and are attributed to
outbreaks in dairy cattle. Historically, human infection has resulted from exposure to sick or
dead poultry and live poultry markets, as well as to other infected animals; in the case of the U.S. outbreak, these animals were dairy cows. Limited, non-sustained human-to-human transmission has occurred globally in the past but has not been seen in the U.S.
CDC prioriti es include supporting and engaging public health and agricultural partners,
protecting human health and safety, understanding the risk to people from HPAI A(H5N1)
viruses, and assessing HPAI A(H5N1) viruses for genetic changes.
As of October 18, 2024, USDA has confirmed HPAI A(H5N1) in U.S. dairy herds in 324 farms
across 14 states. A significant decrease in the quality and production of milk was observed in
early 2024. USDA reported HPAI A(H5N1) confirmed cases in cows from Texas and Kansas on
March 25, 2024.
In 2024, there were 27 reported human cases in the U.S., most of whom had known exposure
to dairy cattle or poultry. Additionally, one case in Missouri had an unknown exposure. The
individuals exposed to dairy cattle and poultry experienced mild clinical symptoms, such as mild
eye irritation, respiratory issues, and systemic effects.
15

  The Missouri case, which had multiple underlying health conditions, was hospitalized with gastrointestinal symptoms, chest pain, and other symptoms not typical of respiratory illness. The
illness, however, was not severe, and the patient recovered. The case was discovered through
regular surveillance. The case’s contacts’ serology results are pending.
Sequences maintain primarily avian genetic characteristics and lack changes to make the virus
better adapted to infect or spread among humans. There is no impact on the current CDC influenza diagnostic assay’s ability to detect A(H5N1) viruses and no known markers of
resistance were detected. Hemagglutinins of human influenza viruses remain antigenically
related to two available Candidate Vaccine Viruses (CVVs). Assessment of newer California viruses is underway. Dr. Shimabukuro reiterated that seasonal vaccines are not expected to protect against influenza A(H5N1) viruses.
All people with direct or close exposure to animals infected with influenza A(H5N1) should be
monitored for illness during exposure and 10 days after their last exposure. Signs and
symptoms may include fever, cough, sore throat, runny or stuffy nose, muscle or body aches,
headaches, fatigue, eye redness, shortness of breath, or difficulty breathing and l ess commonly,
diarrhea, nausea, vomiting, or seizures. If signs or symptoms develop, these persons should
seek medical evaluation for possible influenza testing and antiviral treatment. Symptomatic
people should be isolated away from others during this evaluation. State and local health
departments can facilitate testing and treatment.
The CDC supports state and local health departments monitoring exposed people during and
for 10 days after the last exposure. Over 5,100 people have been monitored, and over 260 have
been tested due to targeted surveillance, and 26 cases have been detected. Through enhanced
regular surveillance, 54,360 specimens have been tested, with one person testing positive (the
Missouri case). There have been no indicators of unusual influenza activity in people, including avian influenza A(H5N1), in regular surveillance.
In June 2024, the Michigan Department of Health collected blood samples from 35 dairy
workers. The samples were tested for antibodies against influenza A(H5N1) and a seasonal influenza virus. None of the participants showed neutralizing antibodies specific to the avian
influenza A(H5N1) virus although many showed antibodies to seasonal influenza viruses . This
suggests that these people were not previously infected with influenza A (H5N1) despite the high risk of exposure.
Ferrets are used to study both the severity and transmissibility of influenza. They exhibit many clinical signs of infection similar to those observed in humans. Dr. Shimabukuro shared that in a study of A(H5N1) viruses, ferrets were inoculated with two A(H5N1) virus strains: Michigan and
Texas. The results showed that the Michigan virus caused less severe illness in ferrets than the
Texas virus. The Michigan virus resulted in less weight loss and lower mortality rates. However,
transmission through respiratory droplets was similarly observed for both viruses. The Michigan
virus is considered better to represent the currently circulating strains of the virus.
16

  The CDC Influenza Risk Assessment Tool (IRAT) is an evaluation tool for prioritizing resources for pandemic preparedness. The U.S. government subject matter experts assess viruses based
on ten risk factors related to their emergence and public health impact. Emergence is the risk of
a novel influenza virus acquiring the ability to spread quickly and efficiently in people. The public health impact is the potential severity of human disease caused by the virus and the burden on society. The IRAT is not intended to predict a pandemic and is not to be used to assess the overall population or individual risk. Based on available data, CDC’s current assessment is that the risk to the general public from avian influenza A(H5N1) virus remains low.
In summary, the overall risk to the public for HPAI A(H5N1) remains low. There is a greater risk for people with close, prolonged, or unprotected exposure to infected animals or environments contaminated by infected animals. Exposed individuals should monitored for symptoms after the first exposure and for 10 days after the last exposure.
Dr. Chu asked whether CDC had sequencing data to indicate changes in receptor binding with
the Texas and Michigan strains that were used in the ferret studies.
Dr. Shimabukuro responded that he currently does not have the data available. However, he
stated that the sequences primarily retain avian genetic characteristics and do not exhibit
changes that would enhance the virus’s adaptation to infect humans.
Dr. Chu inquired whether there can be speculation about why the two viral strains' lethality is
different and whether any household studies are being done to examine transmission in the farm worker communities.
Dr. Shimabukuro said he would have to contact the lab for additional information. He stated that
CDC has teams in the field working with partners to do epidemiologic investigations, contact
tracing, and studying animal -to-human and human-to-human spread, so there will be m ore
information to come.
Dr. Schechter asked if there is additional seroprevalence data for poultry workers in recent
years. He also sought comments on the genetic differences between the Michigan and Texas strains.
Dr. Shimabukuro said he thought that there might be data from outside the U.S. but was unsure
of any data within the U.S. He agreed to follow up on the differences between the strains. Dr. Shaw inquired if H5N1 has been found in wastewater and whether it is possible to identify
humans from animal sources. He also asked if there has been specific outreach to dairy and poultry farm workers to encourage them to receive seasonal influenza vaccines.
Dr. Shimabukuro stated that wastewater surveillance is being done in addition to regular
surveillance. H5N1 has been detected in wastewater and has been usually in areas associated
with animals or animal products but it’s difficult to definitively determine source as animal or
human. There is a program to support jurisdictions with infected herds, promoting seasonal
vaccinations for agricultural workers to protect them from seasonal influenza and potentially
help prevent respiratory illnesses.
17

  Dr. Loehr inquired whether a patient who receives the flu vaccine and contracts the flu will
experience a less severe case.
Dr. Ellington clarified that none of the VE studies presented today were designed to answer this
question, but there are studies with other designs that show less severe illnesses with
vaccination. Dr. Grohskopf added that there are other studies that suggest this.
Dr. Chris Hahn addressed an earlier question about wastewater as an epidemiologist serving
states affected by H5N1.  Although wastewater detection is taking place, it remains unclear where the contamination originates. All impacted states have implemented targeted v accination
efforts, and we are careful in our messaging to clarify that these vaccinations are intended to protect against seasonal influenza .
Dr. Shimabukuro clarified a previous answer on the ferret studies discussed. While he does not
have genetic sequencing, he would like to reinforce that the Michigan human virus better represents currently circulating viruses.
Dr. Kamboj asked whether challenge studies with the candidate virus vaccines are being done
in ferrets .
Dr. Shimabukuro confirmed that other ferret studies are being conducted.
Dr. Chu asked if the at-home flu test detects H5 and whether there is a plan to scale these types of tests in farmworker communities if they do.
Dr. Shimabukuro clarified that if an over -the-counter test detects influenza A, it should also be
able to detect influenza A(H5N1 ). However, these tests do not do subtyping, which must be
done by a laboratory and then confirmed at CDC. There are partnering programs to explore
expanding testing capacity if needed; that work is ongoing.  Dr. Maldonado recalled that the transmission from cows to cats involved drinking raw milk. She
inquired about additional messaging around this information, such as data on the pasteurization
of milk.
Dr. Shimabukuro shared that the CDC recommends that people do not drink raw milk. All the
data point to pasteurization resulting in a safe commercial milk supply. Dr. Daskalakis reinforced that pasteurization is highly effective in addressing H5N1. Both CDC
and FDA have issued clear guidance on raw milk.
Dr. Jeanne Santoli (CDC/NCIRD) shared the Vaccine for Children (VCF) resolution update. The
purpose of this resolution is to (1) update the Inactivated Influenza Vaccine component of the
resolution to add options for vaccination of 18-year -olds who are solid organ transplant
recipients and (2) update the links in the contraindications and precautions sections of both
components of the resolution.
18

  There were no changes to the inactivated component of the influenza vaccine-eligible groups
and the recommended vaccine schedule and dosage intervals. Two vaccine products (Fluzone®
High-Dose and FLUAD®) have been added, which are indicated for people ≥65 years and older.
A table note was added that states, “Persons aged 18 y should receive an age-appropriate influenza vaccine (i.e., one approved for their age), with the exception that solid organ transplant recipients on immunosuppressive medication regimens may receive high-dose inactivated influenza vaccine (HD -IIV3) or adjuvanted inactivated influenza vaccine (aIIV3) as
acceptable options, without a preference over age-appropriate IIV3s.” No changes to dosage,
contraindications, or precautions were made. There is, however, an update to the link for this
information.
No changes have been made to the live attenuated influenza vaccine-eligible groups or their
recommended vaccine schedule and dosage intervals. There are recommendations for the
dosage to be consistent with how it is depicted in the resolution of the inactive influenza vaccine
component and an update to the link of the contraindications and precautions information.
Dr. Kamboj requested that the Work Group consider a high-dose flu vaccine beyond solid organ
transplant, especially for hematopoietic stem cell transplant recipients.
Dr. Brooks questioned whether there was any consideration for younger children.
Dr. Wharton clarified that this resolution aligned VFC with the committee's vote in June.
Younger children were not considered.
Dr. Loehr inquired whether there was a recommendation for recombinant RIV in 18-year -olds
and, if not, why it was not considered.
Dr. Santoli confirmed that this vaccine was not included in the VFC program because it was not
brought forward for inclusion when it was licensed. Managing a vaccine designated to only one
age cohort is also challenging.
Dr. Loehr motioned to approve VFC resolution for vaccines to prevent influenza. Dr. Cineas seconded the motion.
Vote: Influenza Vaccines
Dr. Keipp Talbot (ACIP Chair ) read the following proposed ACIP resolution for Influenza
Vaccines for Children (VFC) into the record:
Approve the Vaccines for Children (VFC) resolution for vaccines to prevent influenza.
19

   Motion/Vote: Influenza Vaccines
Dr. Loehr made a motion to approve the VFC resolution for influenza vaccines. Dr. Cineas
seconded the motion. No COIs were declared. The motion carried with 15 favoring and 0
opposing. The disposition of the vote was as follows:
15 Favored: Asturias, Brewer, Brooks , Chen, Chu, Cineas, Jamieson, Kamboj, Kuchel,
Loehr, Maldonado, Moser, Schecter, Shaw and Talbot
0 Opposed:
0 Abstained:
CHIKUNGUNYA VACCINE S
Dr. Edwin Asturias, chair of the ACIP Chikungunya Vaccines Work Group, introduced the
session. The Work Group was formed in May 2022. The currently available vaccine, Valneva’s
live attenuated vaccine, was licensed in November 2023. A virus -like particle vaccine has been
submitted for licensure by Bavarian Nordic. The Work Group is developing policy options for
ACIP’s consideration for using the chikungunya vaccine among U.S. persons at risk of chikungunya, including travelers, laboratory workers, and residents of U.S. territories and states
with risk of transmission.
Dr. Susan Hills (CDC/NCEZID) updated the committee on chikungunya and chikungunya
vaccines. Chikungunya is a mosquito-borne disease. Key vectors are Aedes aegypti and Aedes
albopictus mosquitoes. It is typically transmitted in tropical and subtropical regions, with about
120 countries and territories where transmission has ever been documented. A key feature of
the virus is that it periodically causes explosive outbreaks, often with high attack rates.
Clinical illness is characterized by fever and joint pain, which is typically severe and can be
debilitating. The approach to management is supportive; no specific antiviral treatment is
available. Rare serious complications include myocarditis, hepatitis, and neurologic illness. Deaths are rare and are primarily seen in older adults, particularly those with comorbidities and
young infants. Acute symptoms usually resolve in 7-10 days. Some patients have continuation
or relapse of their joint symptoms. Studies have reported variable proportions of patients with
persistent symptoms, but ongoing arthralgia of variable severity might be present in up to about half of patients at 3 months after infection and up to about 30% at 12 months. It is a reportable
disease in the United States; approximately 100-200 cases are reported annually among U.S.
travelers, although there is likely substantial underdiagnosis and underreporting. Infections are
most commonly acquired in Asia and the Americas, with specific locations of acquisition
influenced by local transmission patterns, which vary from year to year. Unquestionably, the greatest risk for US travelers to acquire chikungunya is traveling to an area with an outbreak.
Dr. Hills reminded the committee that there is currently one licensed vaccine in the U.S. and one
vaccine submitted to the FDA for licensure. The licensed vaccine is a live attenuated vaccine
manufactured by Valneva as IXCHIQ
®. It was licensed in November 2023 and is currently
approved for use in adults aged 18 years and older. This vaccine has a single-dose schedule.
20

 ACIP approved recommendations for use of this vaccine in adult travelers in February 2024.
The recommendations note that ACIP recommends the live attenuated chikungunya vaccine for
persons aged ≥18 years traveling to a country or territory where there is a chikungunya
outbreak. In addition, the vaccine may be considered for certain persons traveling to a country
or territory without an outbreak but with evidence of chikungunya virus transmission among humans within the last 5 years. The groups include persons aged >65 years, particularly those with underlying medical conditions, who are likely to have at least moderate exposure to mosquitoes, or persons staying for a cumulative period of 6 months or more. ACIP also
recommends live attenuated chikungunya vaccine for laboratory workers who are potentially
exposed to the chikungunya virus. Updates on this vaccine include that for adolescents aged
12-17 years, Valneva plans a submission to the FDA this year, which, if ultimately approved, will allow use in this age group. A clinical trial began in December 2023 and is in progress for children aged 1-11 years. Finally, monitoring of the vaccinated cohort from the pivotal clinical
trial in adults aged ≥18 years is continuing to investigate the persistence of seroresponse
following the single dose of the vaccine. At two years, a high seroresponse rate of 97% was
maintained. Monitoring will continue for 10 years to determine if a booster dose will be needed in the future.
Bavarian Nordic manufactures the second vaccine, and licensure is possible in February 2025.
The virus -like particle vaccine's intended age group is adolescents and adults aged ≥12 years.
The vaccine has a single-dose primary schedule. Like the live attenuated vaccine, the virus -like
particle vaccine will be licensed through the accelerated approval pathway. Traditional approval
would have been challenging, and clinical development would likely have been delayed if this approach had been required. FDA can grant accelerated approval for products that are for
serious conditions and that fill an unmet medical need. In this pathway, the demonstration of
effectiveness is based on controlled clinical trials showing the vaccine affects a surrogate endpoint that is reasonably likely to predict clinical benefit. For the virus -like particle vaccine, the
marker of protection was based on a neutralizing antibody titer estimated from a validated non-human primate model. This pathway has a post-licensure requirement for controlled trials to
confirm clinical benefit.
The ACIP Chikungunya Vaccines Work Group has four groups for whom vaccine
recommendations are being considered. These include travelers, laboratory workers, residents of U.S. territories at risk of chikungunya virus transmission, and residents of U.S. states at risk of transmission. For the live attenuated chikungunya vaccine, ACIP has made
recommendations for use among travelers aged 18 years and older and among laboratory workers; the Work Group is currently considering policy options to present to ACIP for use of the vaccine among residents of US territories and states with risk of transmission. Regarding the virus-like particle chikungunya vaccine, policy options for the use of the vaccine among all four groups are under consideration and will be presented for ACIP’s consideration at future
meetings.
Dr. Victoria Jenkins (Bavarian Nordic) discussed the virus -like particle chikungunya vaccine
(CHIKV VLP). CHIKV VLP consists of 3 recombinant proteins that mimic the virus but cannot
replicate in the host. It is adjuvanted with aluminum hydroxide in a single 40µg VLP dose administered intramuscularly. The PDUFA target action date is February 14, 2025. The
proposed indication is to prevent CHIKV infection in individuals ≥ 12 years of age. The proposed
contraindications are hypersensitivity , including severe allergic reactions, to any component of
the vaccine.
21

  A defined threshold of serum -neutralizing antibodies was used as a surrogate efficacy endpoint
in Phase 3 clinical trials. The CHIKV luciferase assay used in the study was based on the
CHIK181/25 live-attenuated virus (Asian lineage) engineered to express luciferase transgene.
The neutralization assay was based on an 80% reduction of luciferase activity, resulting in an NT
80 value. The assay measures cross -neutralization as the vaccine is heterologous to the
assay strain (West African vs. Asian).
The submitted vaccine clinical program included three Phase 2 studies and two Phase 3 studies
conducted in the U.S. The Phase 2 dose and schedule studies were conducted in healthy
participants aged 18-45 years. The single 40 µg CHIKV VLP adjuvanted dose was chosen for
further development because it had superior immunogenicity after the first vaccination, showed a rapid and durable response, and was well -tolerated. The study also looked at the need for a
booster dose, but the need for a booster is still unknown.
The Phase 3 studies were completed in parallel, placebo-controlled, and conducted in the U .S.
One was done in participants 12 to 64 years of age and the other in adults ≥65 years of age.
Both studies had coprimary end points of superiority of GMT at day 22 vs. the placebo, difference in the seroresponse rate vs. placebo at day 22, and safety. In addition, in the study of
adolescents and adults, lot-to-lot consistency of anti -CHIKV SNA GMT at Day 22 was evaluated
in a subgroup of participants 18-45 years of age. The demographic profile of participants in both
studies were balanced between vaccine and placebo groups. All co-primary and secondary endpoints were met in both studies. CHIKV VLP vaccine was well -tolerated in individuals 12 to
64 years of age. The incidence of adverse events of special interest ( AESI) and medically -
attended adverse events ( MAAE) did not differ between the CHIKV VLP vaccine group and the
placebo group in individuals 12 to 64 years. CHIKV VLP vaccine was well -tolerated in
individuals ≥ 65 years of age. Incidence of AESI and MAAE did not differ between the CHIKV
VLP vaccine group and the placebo group in individuals ≥65 years of age.
Dr. Jenkins summarized that the Phase 3 trials demonstrated a rapid and robust immune
response in individuals ≥12 years of age. A durable and boostable immune response was also
observed in a subpopulation of the Phase 2 trial. The vaccine was well tolerated, and there were no treatment-related SAEs, as determined by the sponsor. Most solicited and unsolicited adverse events were mild or moderate in intensity.
Dr. Cineas inquired whether the studies included immunocompromised patients and those with
chronic medical conditions.
Dr. Jenkins responded that the Phase 3 study only included healthy participants. However,
persons with stable immunocompromising conditions will not be excluded from a Phase 3B
confirmatory efficacy study .
Dr. Susan Hills (CDC/NCEZID) concluded with a review of the work group’s interpretation of
data for the virus -like particle chikungunya vaccine following their preliminary review of the data.
Regarding VE, results are based on immunogenicity data since no VE data is available. Short-
term immunogenicity data reflecting seroresponse rates at 3 weeks after vaccination are available from 2,750 vaccinated subjects in two Phase 3 studies, most of whom were adults
aged 18-64 years, with smaller numbers of adolescents and older adults with data, with about
200 subjects with data in each of these age groups.  The work g roup noted there was a robust
response to vaccination, with seroresponse rates 21 days after vaccination of 98% in adolescents and younger adults and 87% in older adults, and seroresponse rates at 6 months after vaccination of 86% and 76% in the younger and older age groups respectively.
22

 Data after 6 months are not yet available from Phase 3 studies, so the need for a booster dose
is unknown.
Safety data are available from about 3,000 vaccinated subjects in two Phase 3 studies, most of
whom were adults aged 18-64 years. Data from smaller numbers of adolescents aged 12-17 years and adults aged ≥65 years are also available, with about 210 subjects with data in each
age group. Based on the overall data, t he work group concluded that the overall safety profile of
the vaccine was acceptable. Solicited adverse events were reported within 8 days of
vaccination. The following data reflect results among adolescents and adults aged 12 -64 years.
Local events were reported by 24%, with 0.2% graded as severe. Solicited systemic events
were reported by 32%, with severe events in fewer than 2% of subjects. The most frequent events were fatigue, headache, and myalgia, all reported by 18 to 20% of vaccinated persons. There was no concerning signal with arthralgia after vaccination. One serious adverse event – a
retinal detachment --was assessed as related by the study investigator but unrelated by
the safety monitoring committee chair. For adults ≥65 years , all adverse event rates were lower
than those seen in 12-64 -year-olds.
The work group summary for the c hikungunya VLP vaccine:
• Will provide an option, in addition to the licensed live attenuated vaccine, for vaccination
of adults aged ≥18 years
• Will provide a new option for adolescents aged 12– 17 years
• Immunogenic vaccine but no vaccine effectiveness data, which will be gathered post-
licensure, and the need for a booster dose is currently unknown
• There are no apparent safety concerns, but safety data only from ~3,000 people, so data are insufficient to detect rare events, and post-marketing surveillance will be important
• Work g roup to conduct comprehensive data review and present GRADE assessment as
part of the Evidence to Recommendations framework at a future meeting
During 2025, the work g roup anticipates presenting recommendations for ACIP’s consideration
and asking for votes on vaccine recommendations in various groups, including the use of live
attenuated vaccine among travelers aged 12-17 years, use of the virus- like particle vaccine in
travelers aged ≥12 years, use of the virus -like particle vaccine among laboratory workers, use of
both vaccines among residents of U.S. territories with transmission risk, and use of both vaccines among residents of U.S. states with transmission risk.
Dr. Schechter inquired about short- and long-term plans for using the VLP vaccine in pregnant
individuals.
Dr. Hills confirmed that the work group is discussing the topic and will be able to provide
additional details at a future ACIP meeting. The use of the live attenuated vaccine has previously been considered. One of the main recommendations is that pregnant women avoid
traveling to areas with CHIKV if possible, particularly during an outbreak, due to the concern of
infection and subsequent transmission during the intrapartum period. If travel is unavoidable,
the licensed vaccine should be considered a precaution for use, with avoidance during the first
trimester and after 36 weeks of gestation.
Dr. Chu asked whether there were any Development and Reproductive Toxicity (DART) studies
for the VLP vaccine candidate.
23

 Dr. Hills clarified that she was referring to animal data and redirected the question to Dr.
Jenkins.
Dr. Jenkins confirmed that DART data are available and referred to a colleague, Dr Vang.
Dr Vang confirmed that DART studies were conducted in rabbits and rats. The results showed
that the vaccine was safe and there were no observations of concern.
Dr. Maldonado questioned whether the work group was considering making preferential recommendations or whether there might be blanket recommendations for both vaccines and asked whether the work group would continue to monitor strains circulating in the Western Hemisphere.
Dr. Hills confirmed that the vaccines would be considered independently due to the differences
between the vaccines and the way immunogenicity and safety were assessed. For example, with immunogenicity, a different assay was used with a different marker for protection for each vaccine, so those comparisons are difficult. For safety, data are only available for about 4,000 subjects for each vaccine , and with such little data, it’s hard to make definitive comparisons. The
data suggest that the vaccines will protect against the various chikungunya strains, but as usage increases, CDC will be looking for any evidence of vaccine failure.
Dr. Asturias reiterated that the work group should consider the vaccines independently because the surrogates of protection differ. However, given the increasing burden in the Americas, having the option of two vaccines is encouraging.
COVID -19 VACCINES
Dr. Robert Schechter (ACIP, Work Group Chair) introduced this session on behalf of the ACIP
COVID -19 Vaccines Work Group. As a reminder, ACIP recommended 2024– 2025 COVID-19
vaccines as authorized or approved by the FDA in persons ≥6 months. Everyone ≥5 years
should get one dose of a 2024– 2025 v accine. Children aged 6 months -4 years need multiple
doses of COVID -19 vaccine to be up to date, including at least one dose of the 2024– 2025
vaccine. Moderate or severely immunocompromised people may receive additional 2024– 2025
vaccine doses. There are no recommendations for additional 2024– 2025 doses for older adults.
Today’s session will focus on additional doses for adults ages 65 years and older and moderate
or severely immunocompromised people.
Dr. Georgina Peacock (CDC/NCIRD) presented the implementation considerations for
additional COVID -19 vaccine doses. For children, coverage of 2024– 2025 vaccine to date is
3.7% vs. 3.1% of 2023– 2024 vaccine at this time last year. For adults ≥18 years of age,
coverage of 2024– 2025 vaccine is 11.7% vs. 6.8% 2023– 2024 vaccine at this time last year,
and for ages ≥75 years , coverage is 30.6% vs. 17.7% last year.
Among adults ≥65 years of age, vaccination coverage for ≥1 2023– 2024 COVID-19 vaccine
dose through June 2024 was about 40% and 8.9% for ≥2 doses of 2023– 2024 COVID-19
vaccine, based on the National Immunization Survey-Adult COVID Module. Within the group
receiving ≥2 doses, higher coverage is seen in urban than in rural areas. Minimal differences in
≥2 dose coverage are seen by low, moderate, or high Social Vulnerability Index. Higher
coverage is seen in people with underlying health conditions and those with a healthcare
provider’s recommendation.
24

 36.8% of ≥65-year -olds surveyed from April -June 2024 had received ≥1 2023– 2024 COVID-19
vaccine dose. Of that 36.8% who received ≥1 dose, 20% were vaccinated with ≥2 doses, 44.3%
“definitely will get another dose,” 30.9% “probably will get another dose,” and 4.7% “probably or
definitely will not get another dose.” There was greater intention to get a second dose in people ≥80 years of age and people living in urban areas. From April to June 2024, there was a modest increase in the intent of adults ≥65 years of age to receive another dose.
Among immunocompromised adults aged ≥18 years, 5.4% received ≥2 doses of 2023– 2024
COVID -19 vaccine through June 2024. Within this group, higher coverage is seen among
immunocompromised adults ≥65 years old, those living in suburban areas, those who had
received a healthcare provider recommendation, and those with insurance.
The Omnibus Survey of adults ≥18 years of age with health conditions and adults age d ≥65
years , conducted in August 2024, asked respondents whether they intended to receive a
second dose for the current season if it were recommended. Overall, one -third of those
surveyed intended to receive a second dose. Intentions were higher among adults over 65
years old. There was lower intent in rural areas and among those who are uninsured.
The proposed recommendations for additional doses would not be overly burdensome to
implement because the additional dose would be the same formula as the current vaccine, there
is administration infrastructure and product can be used, and the recommendations can be
integrated into existing systems and structures. Minor challenges include the need for additional
education and a possible increase in existing vaccine fatigue as well as availability at practices
after the fall supply has been exhausted.  The new proposed recommendations include “should” rather than “may” (or shared clinical
decision-making) recommendations for overall ease of implementation. The recommended and minimal interval for vaccination is consistent with language for other vaccines. It is also standardized across adults aged ≥65 years and immunocompromised populations, which eases
implementation. Furthermore, a minimum interval of 2 months allows for flexibility in vaccine administration when accounting for individual risks and circ umstances.
Of adults aged ≥18 years who have received a 2024– 2025 COVID -19 vaccine, the majority
(81.9%) received their vaccination at a pharmacy or drug store. Similarly, of adults aged ≥65
years who received a 2024– 2025 COVID -19 vaccine, the majority (82.8%) have received their
vaccination at a pharmacy or a drug store. Within pharmacy settings, “may” (or shared clinical decision-making) recommendations can be challenging. CDC has dedicated healthcare provider engagement to assist with the denial of vaccination that may take place due to changes in guidance. Differences in vaccine access can create disparities in uptake, and these may be
exacerbated by due to issues with insurance, disability, and vaccination settings (e.g., long-term
care).
Dr. Swamy made a statement representing the American College of Obstetricians and
Gynecologists. The group is supportive of the COVID -19 vaccine in pregnancy . Data show that
the vaccine is safe and efficacious and decreases the risk of severe disease and hospitalization rates in infants when administered in pregnancy. Maternal vaccination can help reduce the risk
of transmission to newborns during pregnancy, delivery, and breastfeeding. Due to the decreased rate of vaccination within this population, the group feels COVID -19 vaccine should
be prioritized and recommended.
25

 Dr. Christopher Taylor (CDC/NCIRD) presented updates on COVID -19-associated
hospitalizations. COVID -NET data captures 10% of the U.S. population, and data presented
today will be limited to hospitalizations identified in 90 counties across 12 states. Hospi tals
reported all positive SARS -CoV -2 test results within 14 days before or during
hospitalizations. Clinical data are collec ted from an age- and site-stratified random sample.
Adults ≥65 comprise 70% of all COVID –19–associated hospitalizations among adults ≥18 years
of age from October 2023 to September 2024. Rates of COVID -19 hospitalizations are highest
among adults ≥75 years of age. COVID –19–associated hospitalizations increased with age from
October 2023 to September 2024. Rates among those ≥75 years of age are three times as high
as adults aged 65-74 years , nearly nine times as high as adults aged 50- 64 years , and 24 times
as high as adults 18-49 years of age .
Since March 2020, rates of COVID –19–associated hospitalizations among adults aged ≥65
years have decreased, but hospitalizations among adults aged ≥75 years remain the highest
across all age groups. Most adults aged ≥65 years hospitalized with COVID -19 have underlying
medical conditions. Adults aged ≥65 years remain at risk for severe outcomes during COVID –
19–associated hospitalization. Between October 2023 and May 2024, 80% of all adults
hospitalized with COVID- 19 who died in-hospital were aged ≥65 years. Data suggests that
deaths following hospital discharge are more common among older adults within 30 days of
release. Fewer than half of adults aged ≥65 years hospitalized with COVID -19 have received
any COVID -19 vaccine since September 2022.
Some conditions defined as immunocompromising according to COVID -NET are time-bound
relative to admission for COVID -19-associated hospitalization. Immunosuppressive therapy is
only considered if treatment was received 12 months before admission. Cancer is only
considered if treatment or diagnosis occurred in the 12 months before admission. Inhaled,
intranasal, intramuscular, or intraarticular steroids are also not included. Between July 2023 and
May 2024, about 15.6% of people hospitalized with COVID -19 had an immunocompromising
condition. Three percent of children aged ≤4 years and 15-22% of hospitalized adults had an
immunocompromising condition.
The most common immunocompromising conditions were immunosuppressive therapy (46%),
solid organ malignancy (34%), steroid therapy (26%), and metastatic cancer (22%) . Few
persons with an immunocompromising condition hospitalized with COVID -19 had received any
COVID -19 vaccine since September 2022.
The time since receipt of the most recent COVID -19 vaccine varied little by the status of the
immunocompromising condition. The risk for severe outcomes during COVID –19–associated
hospitalization among children and adolescents varied little by immunocompromising condition
status ; in contrast, the risk for severe outcomes during COVID –19–associated hospitalization
among adults did vary by immunocompromising condition status.
Dr. Ruth Link -Gelles (CDC/NCIRD) presented the effectiveness of COVID -19 vaccines to inform
ACIP deliberations for two questions: the need for additional doses among those with
immunocompromise and the need for additional doses in those aged ≥65 years. Critical issues
in COVID -19 vaccine effectiveness (VE) include the impact of time since dose on protection, the
impact of changing SARS-CoV -2 variants over time and variant/vaccine mismatch, and the
effect of surges in disease, seroprevalence, and time since the last SARS -CoV -2 infection. As
context for interpretation of VE, there were high rates of SARS-CoV -2 infection-induced
immunity by July -August 2023 among all age groups.
26

  VE findings should, therefore, be interpreted as the added benefit of COVID -19 vaccination in a
population with a high prevalence of vaccine- and infection-induced immunity.
Absolute VE is a measure comparing the frequency of health outcomes in vaccinated vs. unvaccinated people. Relative VE compares the frequency of health outcomes in people who received one type of vaccine to people who received a different type. For 2023-2024 COVID -19
VE, VE was measured by comparing people who received a 2023-2024 dose to those who did not, regardless of past vaccination. This is similar to how influenza VE is measured annually.
VE findings should be interpreted as the added benefit of CO VID-19 vaccination in a population
with a high prevalence of vaccine- and infection-induced immunity at the start of the 2023-2024
respiratory virus season.
Dr. Link -Gelles presented results from three VE platforms.  VISION is a m ulti-site network of
>300 emergency departments and urgent cares and >200 hospitals, utilizing a test-negative
design and vaccination status from electronic health records and city and state immunization
registries. The IVY Network is a multi -site VE platform that uses a test-negative design with
vaccination status from electronic medical records, city and state registries, and plausible self-report.  Medicare studies used a retrospective cohort design from Medicare-fee-for -service
claims data.
Study results presented by Dr. Link -Gelles showed that COVID -19 vaccines protected both
persons with and without immunocompromise. Patterns of COVID -19 VE in
immunocompromised people differed from season to season, with generally lower VE compared
to non-immunocompromised people but inconsistent waning patterns. During 2023-2024, VE
against hospitalization in immunocompromised people waned to 0 by ~4-6 months.
In adults aged ≥65 years, 2023-2024 COVID -19 vaccination provided increased protection
against COVID -19-associated emergency department and urgent care ( ED/UC) visits and
hospitalizations compared to no 2023-2024 vaccine dose. Protection waned to 0 against
COVID -19-associated ED/UC visits and hospitalization by ~4-6 months. Waning patterns of
2023-2024 COVID -19 vaccines appeared similar to previous COVID -19 vacc ine formulations;
the most durable protection appeared to be for critical illness. VE against cri tical illness
remained above 40% at 5 months after vaccination among adults aged ≥65 years. As with
previous COVID -19 vaccine formulations, effectiveness was similar across age groups. Data
from prior seasons show that an additional dose of the same formul a appeared to provide
additional protection.
Dr. Chu inquired whether messaging was targeted at providers of patients in long-term facilities
to increase low vaccine rates in these groups. She also asked whether CDC could measure the
vaccine's impact on long -term COVID -19.
Dr. Peacock stated that efforts have been made to increase vaccine rates within this group, but
they have had limited success. Dr. Link -Gelles said that research on long-term COVID is
challenging because its symptoms can resemble those of many other illnesses. Studies have been conducted on this and generally have found some level of protection by vaccination, but results vary across studies. This is an ongoing area of research both by CDC and by other
groups.
27

  Dr. Schechter expressed concern for lower vaccination rates among populations ≥65 years of
age and older and pregnant women. COVID -NET shows that only 15% of adults ≥65 years of
age received the 2023-24 C OVID vaccine last year, and that of pregnant women whose infants
6 months of age and younger were hospitalized, fewer than 5% were vaccinated.
Dr. Asturias requested clarity on the difference in rates of COVID-19 outcomes among
immunocompromised children on slide 17 of Dr. Taylor’s presentation. The Colorado data show that the rate of hospitalization of healthy children under 1 year of age is relatively high and
comparable to adults over 60 years of age.  The children with immunocompromising conditions are probably somewhat older.
Dr. Taylor confirmed that infants under six months are comparable to adults older than 65-74 years of age. There are some differences between the populations, but the immunocompromise
group's sample size is small, and because of that, it was presented as a broader age group.
Ms. Moser thanked the people who submitted comments on this portion of the agenda. She
understands why we are studying the VE and comparing it to last year, but it would be helpful to
better understand the “no recent vaccine” comparison group. It is essential to help people
understand their protection level moving forward.
Dr. Loehr commented that the incidence rate of hospitalization increased with age. It is stunning
that 1 in 70 adults will be admitted to the hospital for COVID. He also stated he is torn on the
recommendation for 6 months between the first and second doses. Patients want to get the vaccine in July or August because of a trip and are unsure whether they can receive the next
dose in September. I usually say 4 months, but that does not necessarily meet the 6-month time
frame.
Dr. Brewer stated that the audience would better follow the presentation if there were language
to frame VE data on slides 25 and 26 for the final row of 18-64-year -olds. He also asked for
clarification on how this data should be interpreted.
Dr. Link -Gelles clarified that the “7-299 days earlier” is just an average breakdown for the four
categories below. Dr. Brooks stated that the risk for ED/UC visits is increased by about 20% in each category on
the same slide. He asked how one interprets the slides and whether the data on this slide reflect
relative VE.
Dr. Link -Gelles clarified there is no biological plausibility for a vaccine increasing your risk of
disease, so that is not what we think has been happening in the longest time since vaccination.
VE, at its root, essentially measures the risk of disease in a vaccinated population compared to
an unvaccinated population. The unvaccinated or less vaccinated group can significantly impact
the estimated VE. In this case, unvaccinated people get infected in the 6 months while
vaccinated people are protected by their vaccine. That raises the infection-induced immunity level in unvaccinated people, which may make the VE look very low when the vaccine has
waned, such that vaccinated people are now susceptible. This is a combination of relative and
absolute VE.
28

  Dr. Kuchel commented that chronological age is a good research measure for most adult populations. However, as someone practicing geriatric medicine, chronological age is an
imperfect measure within older populations. He requested that some VE data be stratified by
sex in addition to age because men and women do not age similarly.
Dr. Brewer requested an estimate of how much of the waning immunity in the control group is
due to natural infection.
Dr. Link -Gelles described that the earlier phenomenon of the population getting infected, which
results in lower than expected VE, probably impacts VE more the further away you get from
vaccination. Measured VE can change quite a bit based on background rates of disease. For
example, lower VE will be measured if there is a disease surge the month before a vaccine is introduced and the population has a very high rate of infection-induced immunity. The exact
amount is difficult to quantify, especially since serology is unavailable in most of our studies.
Dr. Lisa Prosser (University of Michigan) presented the economic analysis of an additional dose
of the 2024– 2025 COVID-19 vaccine. Updates to the current version of the model include a 2-
dose strategy (an additional mid-year dose), 2023-2024 hospitalization rates (COVID -NET
data), CDC -negotiated 2024-2025 prices for vaccine costs , and adjustment of all cost inputs to
2024 dollars.
Weekly rates of COVID -19-associated hospitalizations by season for all ages have been
declining in recent years. For the 2023-2024 season, the probability of hospitalization due to
COVID -19 illness has dropped for all age groups, ranging from 14% lower in the 65 and older
age group to 33% lower in the 18-49 year age group compared to the 2022-2023 season. The analysis plan included a base case and uncertainty analyses. The outcomes were stratified
by intervention strategy and by age subgroups. Vaccination for the 2-dose strategy economic analysis shows that the ICERs for age groups <65 years old were less favorable than those ≥65
years old across plausible parameter ranges. For ≥ 65-year -old age group, ICERs were most
sensitive to seasonality -adjusted vaccine impact, probability of hospitalization, and vaccination
costs. ICERs are more favorable in scenarios with a higher risk of hospitalization and lower
vaccination costs.
Dr. Shaw questioned whether models accounted for the costs of potential post-infection care,
e.g., transient or permanent residence in a skilled nursing facility, and the cost of a family
member who may need to leave work to care for an elderly adult.
Dr. Prosser responded that the costs associated with hospitalizations and complications are
from MarketScan data, which includes episode cost and some costs paid for by the health plan.
It is highly likely that some of those costs would not be incorporated there if they’re covered at
the family level. This would include a conservative estimate of those costs. The cost of informal
caregiver time, primarily associated with hospitalization, has been included in the model.
Dr. Loehr commented that he buys his vaccines as a small family practice owner. The current
prices at which he purchases the vaccines are about 30% less than what is listed on the private
market price slide.
29

 Dr. Prosser agreed that this was an important point to share. Looking at an approximate $100
per dose, for the additional dose strategy, the corresponding incremental cost-effect ratios
remain above $600,000 per QALY for age groups under 65 years ; perhaps we can get closer to
$200,000 per QALY for those 65 and older using a lower vaccine cost.
Dr. Schechter reflected on the previous summer's surge, which had higher hospitalizations in
California than the 2023 surge.  He asked whether this was reflected in national hospitalization
statistics , and about the impact of hospitalization rates on these estimates .
Dr. Taylor responded that COVID -NET is comprised of multiple sites, and each site was
different. Some sites that had a mild winter had a larger summer surge. Sites with very high rates during the winter peak in December and January saw a more moderate summer surge.
Dr. Brewer requested that Dr. Prosser speak about how equity would be cost-effective and how the model addresses the cost of time loss (e.g., post-vaccine side effects, time off work to receive the vaccine, etc.).
Dr. Prosser stated that there had been no formal incorporation of health equity considerations
into the model. Vaccination would be more cost-effective if a population or sub-population had
higher rates of illness, hospitalization, or death. This could be a way to think about equity within
this presentation. This is not a current goal in this analysis but can be considered in a future
study. Regarding time loss, some costs are incorporated into the time required to receive
vaccination.
Ms. Lauren Roper (CDC/NCIRD) reviewed the Evidence to Recommendations ( EtR) framework
for additional doses of the 2024– 2025 COVID -19 vaccine in older adults and people with
moderate or severe immunocompromise. On June 27, 2024, ACIP voted to recommend 2024–
2025 COVID-19 vaccines for everyone ages ≥6 months. On August 22, 2024, the FDA
approved and authorized 2024– 2025 Pfizer -BioNTech and Moderna COVID -19 vaccines for
people ages ≥6 months. On August 30, 2024, the FDA authorized the 2024– 2025 Novavax
COVID -19 vaccine for people ages ≥12 years of age.
The EtR framework policy questions are, in addition to previously recommended 2024-2025
vaccination:
• Should a second dose of 2024– 2025 COVID -19 vaccine be recommended for adults
ages 65 years and older?
• Should a second dose of 2024– 2025 COVID -19 vaccine be recommended for people
ages 6 months and older who are moderately or severely immunocompromised?
• Should additional doses (i.e., 3 or more) of 2024– 2025 COVID-19 vaccine be
recommended for people ages 6 months and older who are moderately or severely
immunocompromised under shared clinical decision-making?
Currently, the ACIP recommends that people age d ≥5 years receive one dose of the 2024– 2025
COVID -19 vaccine at least 2 months after receiving their last dose. People who are previously
unvaccinated for COVID -19 and receive Novavax should complete a 2-dose initial series.
Current recommendations for people aged ≥6 months who are moderately or severely
immunocompromised include a homologous initial COVID -19 vaccine series with at least 1
2024– 2025 COVID-19 vaccine dose, and they may receive one additional 2024– 2025 COVID -
19 vaccine dose with an option for further additional doses of 2024– 2025 COVID -19 vaccine
informed by the clinical judgment of a healthcare provider and personal preference and
circumstances.
30

  Regarding the public health problem, Ms. Roper shared that SARS -CoV-2 continues to circulate
year-round, with peaks occurring in the winter and late summer, compared to influenza and
RSV, which have clearer increases during the typical respiratory virus months, with periods of
low activity during the summer . Adults ≥65 years of age have the highest rates of
hospitalizations due to COVID -19. Older adults also have the highest rates of death due to
COVID -19. Adults ≥65 years of age have higher vaccination- only seroprevalence rates than
younger age groups . Hospitalizations are highest among American Indian/Alaska Native non-
Hispanic persons, followed by Black non-Hispanic persons, and are lowest among Asian and
Pacific Islander non-Hispanic persons. The number of chronic conditions a person has
increases with increasing age and is higher among Black non-Hispanic persons than among other racial and ethnic groups. About 1 in 6 people hospitalized with CO VID-19 have an
immunocompromising condition. Risk for severe outcomes during COVID –19–associated
hospitalization among adults varies by immunocompromising condition status. After reviewing
this domain, the work group felt COVID-19 disease among adults ≥65 years of age and among
people with moderate or severe immunocompromise is of public health importance.
For benefits and harms, adults ≥65 years of age who received a 2023– 2024 COVID -19
vaccination had increased protection against COVID -19-associated ED/UC visits and
hospitalizations compared to people who had not received a 2023– 2024 vaccine dose.
Protection waned to 0 against COVID -19-associated ED/UC visits and hospitalization by ~4-6
months. Waning patterns of 2023– 2024 COVID -19 vaccines appeared similar to previous
COVID -19 vaccine formulations; most durable protections appeared for critical illness. VE
against critical illness remained above 40% at 5 months after vaccination among those ≥65
years of age. VE was similar across age groups. Data from prior seasons shows that an
additional vaccine dose appeared to provide some extra protection. Updated COVID -19
vaccination helped protect COVID -19–related thromboembolic events. Based on modeling data,
annual and semiannual COVID -19 vaccine doses are likely to have the largest benefit in adults
≥65 years of age and people who are immunocompromised.
COVID -19 vaccines protected persons both with and without immunocompromise. Patterns of
COVID -19 VE in immunocompromised persons differed from season to season, with generally
lower VE than non-immunocompromised person s but with inconsistent waning patterns. During
2023– 2024, VE against hospitalization in people with immunocompromising conditions waned
to 0 by ~4-6 months. The inconsistency in waning patterns is likely multifactorial, including
heterogeneity among those classified as immunocompromised, variation in underlying immunity
and response to prior infection, and differing health behaviors over time and by
immunocompromised status.
Safety surveillance demonstrated that serious adverse events after COVID -19 vaccination have
been rare. Anaphylactic reactions have been rarely reported following receipt of COVID -19
vaccines. There is a rare risk of myocarditis and pericarditis; however, this is predominately in
males ages 12-39 years. No increased risk has been observed in adults aged ≥65 years.
Whether the risk might be different in immunocompromised people is unknown. COVID -19
vaccine doses continue to be reactogenic. The rate of local and systemic reactions reported to V-safe was lower with additional doses than after the initial series. Most vaccine recipients have mild reactions, but during 2023– 2024, at least 10% reported health impact events during the 7
days post- vaccination, such as being unable to complete daily activities. Symptoms are less
frequent and severe among older adults than adolescents and younger adults.
31

 After reviewing this domain, the work group felt that the desirable anticipated effects of a second
dose of 2024– 2025 COVID -19 vaccine in adults ages ≥65 years were moderate to large. The
work group majority felt that the undesirable anticipated effects of a second dose of a 2024– 2025 COVID-19 vaccine in adults ages ≥65 were small, with a minority choosing minimal. The work group felt that the balance of benefits and harms favored the intervention of a second dose in this group. The work group felt that the desirable anticipated effects of a second dose of 2024– 2025 COVID-19 vaccine in people with moderate or severe immunocompromise was
moderate. The work group majority thought that the undesirable anticipated effects of a second
dose of 2024– 2025 COVID-19 vaccine in people with moderate or severe immunocompromise
were small, with a minority polling minimal. The work group felt that the balance of benefits and
harms favored the intervention of a second dose in this group. The work group felt that the desirable anticipated effects of a third dose of 2024– 2025 COVID -19 vaccine in people with
moderate or severe immunocompromise was moderate. The work group majority thought that
the undesirable anticipated effects of a third dose of 2024– 2025 COVID -19 vaccine in people
with moderate or severe immunocompromise were minimal to small. The work group was split
between the balance of benefits and harms, favoring the intervention and being unclear.
For the values domain, adults ≥65 years of age surveyed were more concerned about COVID -
19 disease and had higher confidence in vaccine safety and vaccine importance. The work
group felt “moderately” that adults ≥65 years of age feel the desirable effects are large relative
to undesirable effects. The work group opinion was split between “probably important uncertainty or variability” and “probably not important uncertainty or variability” in how adults ≥65
years of age value the main outcome. Limited data exists on the concern about COVID -19
disease, specifically in people with moderate or severe immunocompromise. The work group
opinion was moderate to large that people with moderate or severe immunocompromise feel the
desirable effects are large relative to undesirable effects. The work group opinion was split
between “probably important uncertainty or variability” and “probably not important uncertainty or variability” in that people with moderate or severe immunocompromise value the main outcome.
For the acceptability domain, the percent vaccinated with 2023– 2024 COVID -19 vaccine
coverage was higher for adults ≥65 years of age compared to younger age groups. 39.3% of
adults aged ≥65 years and 5.4% of immunocompromised adults received at least two 2023–
2024 vaccine doses. A healthcare provider recommendation for the COVID -19 vaccine was
highest among adults ≥65 years of age. In an October 2024 survey of healthcare providers,
70% of respondents reported recommending a second COVID -19 vaccination to el igible
patients ≥65 years of age “most of the time“ or “always” and 68% reported recommending a
second COVID-19 vaccination to eligible patients who were immunocompromised “most of the time” or “always.” Feedback through the work group professional organization liaisons indicated they prefer age-based recommendations over risk -based or shared clinical decision- making,
frequent changes in vaccine recommendations create confusion, most preferred one to two total doses a year, and need to reiterate that self-a ttestation of being moderately or severely
immunocompromised is permissible.
2023– 2024 COVID-19 vaccine coverage of ≥2 doses among adults aged ≥65 years of age
varied by race, ethnicity, and urbanicity. Coverage was higher in Black, non-Hispanic adults
compared to white, non-Hispanic adults. Coverage was also higher in urban settings compared
to rural. 2023– 2024 COVID -19 vaccine coverage of ≥2 doses among immunocompromised
adults ≥18 years varied by urbanicity, race and ethnicity, healthcare provider recommendation, and insurance status. Coverage was lower in Asian adults compared to white, non-Hispanic
adults. It was also higher in suburban areas compared to rural areas.
32

  Coverage was higher among people with health insurance and among those with a healthcare
provider recommendation.
When asked if recommending a second dose of the 2024– 2025 COVID -19 vaccine for adults
ages ≥65 years of age would be acceptable to key stakeholders, the work group’s opinion was
“probably yes” and “yes.” When asked if recommending a second dose of the 2024– 2025
COVID -19 vaccine for people ages ≥6 months with moderate or severe immunocompromise
would be acceptable to key stakeholders, the work group’s opinion was “probably yes” and
“yes.” When asked if recommending additional doses (i.e., three or more) of the 2024 – 2025
COVID -19 vaccine for people ages ≥6 months with moderate or severe immunocompromise
would be acceptable to key stakeholders, the work group’s opinion was “probably yes” and
“yes.”
For the feasibility domain, based on survey data, physicians think shared clinical decision-
making (SCDM) increases time and confusion. When asked if a second dose of 2024– 2025
COVID -19 vaccine was feasible to implement among adults ≥65 years of age, the work group’s
opinion was “yes,” with a minority saying, “probably yes.” When asked if a second dose of 2024– 2025 COVID -19 vaccine is feasible among persons with moderate or severe
immunocompromise, the work group’s opinion was split between “probably yes” and “yes.”
When asked if additional doses (i.e., three or more) of 2024– 2025 COVID-19 vaccine were
feasible to implement among persons with moderate or severe immunocompromise, the work group’s opinion was split between “yes” and “probably yes”.
In the resource use domain, administering a second dose of the COVID -19 vaccine is most
cost-effective for older adults, who experience the highest disease burden. An additional dose is
likely more cost-effective in populations with a higher prevalence of risk factors. There was no
information specific to the cost-effectiveness of additional doses in people with moderate or
severe immunocompromise. When asked if a second dose of the 2024– 2025 COVID-19
vaccine in adults ≥65 years old is a reasonable and effi cient allocation of resources, the work
group answered “yes” and “probably yes.” When asked if a second dose of the 2024– 2025
COVID -19 vaccine in persons ≥6 months of age with moderate or severe immunocompromise
was a reasonable and efficient allocation of resources, the work group answered “yes” and “probably yes.” When asked whether additional doses (i.e., three or more) of the 2024 –
2025 COVID -19 vaccine in persons ≥6 months of age with moderate or severe
immunocompromise would be a reasonable and efficient allocation of resources, the work
group’s opinion was split between “probably no,” “probably yes,” “varies” and “don’t know.”
The work group felt that a harmonized recommendation for older adults and
immunocompromised people would ease implementation. Still, some work group members did
not favor a harmonized recommendation but supported differing recommendations in the two
populations under consideration. Limited data for immunocompromised people makes making
recommendations challenging. Despite hesitations about a shared clinical decision-making
recommendation, many work group members acknowledged the benefit for people with
moderate or severe immunocompromise. Allowing flexibility in additional doses may allow these patients to time around travel, life events, chemotherapy, etc.
There was a low uptake of more than one dose of the 2023– 2024 vaccine. The complexity of
the existing schedule has led to reduced adherence by clinicians. Provider recommendations
directly impact uptake, and as part of this recommendation, provider educati on and ensuring
providers are on board is critical to improving adherence. More straightforward vaccine recommendations may increase vaccine uptake.
33

 Focusing on the number of doses of 2024– 2025 vaccine rather than additional doses in
recommendations could help reduce complexity and improve uptake.
The proposed voting language is as follows:
In addition to previously recommended 2024– 2025 vaccination: ACIP recommends a
second dose* of 2024– 2025 COVID-19 vaccine for adults ≥65 years. ACIP recommends
a second dose** of 2024– 2025 COVID-19 vaccine for people ages 6 months –64 years
who are moderately or severely immunocompromised. ACIP recommends additional
doses (i.e., 3 or more doses) of 2024– 2025 COVID-19 vaccine for people ages 6 months
and older who are moderately or severely immunocompromised under shared clinical decision-making
*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age-appropriate 2024– 2025
COVID -19 vaccine 6 months (minimum interval 2 months) after second dose.
**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024– 2025
vaccine are recommended, and depending on vaccination history more may be needed. This
additional 2024– 2025 vaccine dose is recommended 6 months (minimum interval 2 months)
after completion of initial vaccination series.
Dr. Lakshmi Panagiotakopoulos (CDC/NCIRD) shared the clinical considerations. The routine schedule is the schedule for people without moderate or severe immune
compromise. The proposed recommendations for adults ages 65 years and older are for two
doses of 2024– 2025 COVID -19 vaccine at a recommended interval of 6 months (and a
minim um interval of 2 months). Having a recommended and minimum interval is standard for all
vaccines and additionally allows for some flexibility in the timing of doses. For those adults 65 and older who have never received a COVID -19 vaccine and are receiving their first dose of
Novavax vaccine, two doses are recommended as their initial vaccination series, followed by a third dose of any age-appropriate COVID -19 vaccine 6 months after their second dose, with the
same 2-month minimum interval.
People with moderate or severe immune compromise ages 6 months and older are
recommended to get an initial COVID-19 vaccine series – this consists of 3 homologous mRNA
COVID -19 vaccine doses or 2 Novavax COVID- 19 vaccine doses. The proposed
recommendation for 2024– 2025 COVID -19 vaccine doses is for at least two doses with a
recommended interval of 6 months and a minimum interval of 2 months. One of these two doses may be a part of the initial vaccination series, and at least 1 of the 2 doses should be recei ved 6 months after completion of the initial series. Beyond that, the additional doses for
2024– 2025 COVID-19 vaccine would remain under shared clinical decision-making 2 months
after the last dose of 2024– 2025 COVID -19 vaccine.
When transitioning from a younger to an older age group, the CDC recommends that people receive the age-appropriate vaccine product and dosage based on their age on the day of vaccination, which is consistent with CDC’s General Best Practices for Immunization.
Specifically, if a person moves up to an older age group between vaccine doses, they should receive the vaccine product and dosage for the older age group. The previous option to administer a lower dosage is no longer authorized for children who transition from age 4 to 5 and for children moderately or severely immunocompromised who transition from 11 to 12.
34

 The main interchangeability language remains the same – in which COVID -19 vaccine doses
from the same manufacturer should be administered whenever recommended. However, there
are circumstances in which vaccines from different manufacturers may be administered,
including the same vaccine not being available at the time of the clinic visit, the previous dose unknown, a person who would not otherwise receive a vaccine dose, and a contraindication to previously received COVID -19 vaccine. Of note, a VAERS report is not indicated in these
circumstances, meaning these are not considered errors. People ages 12 years and older who initiate vaccination with Novavax and receive the first dose of Novavax should complete a 2
dose initial series with Novavax vaccine. However, if more than 8 weeks have elapsed since
receipt of the first dose, any 2024– 2025 COVID -19 vaccine may be administered. As a
reminder, COVID -19 vaccine is recommended for everyone ages 6 months and older,
regardless of prior symptomatic or asymptomatic SARS- CoV-2 infection, including people with
long COVID . People who recently had SARS CoV -2 infection may consider delaying a COVID -
19 vaccine dose by 3 months from symptom onset or positive test if the infection was asymptomatic. Individual factors, such as risk of severe COVID-19 and current indicators of community transmission, should be considered when determining whether to delay getting a
COVID -19 vaccination after infection.
The interim Clinical Considerations for Use of COVID-19 Vaccines in the United States
webpage continues to be rapidly updated to reflect the most recent COVID -19 vaccine
guidance. COVID-19 vaccine recommendations have moved towards simplicity and the standard language used for the ACIP routine immunization schedule and General Best
Practices. Recommendations for additional doses in older adults and people with moderate or severe immunocompromise will be updated following the October 2024 ACIP meeting votes.
Dr. Loehr thanked the public for the emails and comments on this topic. There has been a
strong push to offer the vaccine to anyone who wants it, not just to individuals ≥65 years of age and immunocompromised. Individuals who care for ill family members are requesting additional vaccine doses. I am not comfortable with that. If an individual is willing to pay for an extra dose
out of pocket for off-label use of a vaccine, I do not see a reason why they should not be able to
do so.
Dr. Panagiotakopoulos responded that this did come up in the work group discussion. The two
considerations were that this is not done for other vaccines and the cost from a societal perspective. It would be unusual to have this done for the COVID -19 vaccines when it is not
done for other vaccinations.
Dr. Wharton clarified that paying out- of-pocket for off-label use of vaccines is generally allowed
as part of medical practice.
Dr. Asturias questioned whether language should include anything about the ideal time before
surges or whether this should be left to others' discretion.
Dr. Panagiotakopoulos replied that considerations for the 6-month recommendation included
waning, cost -effectiveness, feasibility , values, and attitudes ; some providers who take care of
immunocompromised patients expressed that annual vaccination would be sufficient because of
the difficulty of vaccinating more than once a year.  The two-month minimum interval provides
flexibility , allowing local and personal factors to be considered.
35

 Dr. Cineas requested clarification on the interim clinical considerations, whether the guidance
on the interchangeability slide refers to children 6 months to 4 years old, and whether this
should be added for clarity.
Dr. Panagiotakopoulos stated that in addition to 6 months to 4 years, this also applies to
immunocompromised people, people who are recommended to get a homologous series, and people receiving Novavax and who were previously unvaccinated.
Ms. Moser added that some people who were caregivers of high-risk people commented on the
public forum and stated that they could not get the vaccine when they were willing to pay out of pocket. If this is allowed, we should ensure the providers and pharmacists know they can provide them. There were also educators and parents of young children concerned that the families would get the vaccine in the fall and would have to wait a whole year to get it again.
When people are infected, they can defer for three months, but now we are saying vaccination
after six months.
Dr. Fleming-Dutra clarified that while off-label vaccinations are allowed under the practice of
medicine, some complexities make it difficult, and this will be discussed in a later session. In
certain jurisdictions, there are places where vaccines cannot be given if they are not ACIP -
recommended. Although physicians may be able to prescribe it off-la bel, patients may have
difficulty accessing said vaccine. Specific to COVID-19, vaccines must be used in alignment
with HHS guidance.
Dr. Shaw requested clarification on which group the statement: "Individual factors such as the
risk of severe COVID -19 and current indicators of community transmission should be
considered when determining whether to delay getting a COVID -19 vaccination after infection."
The vaccine may be ineffective if vaccinated too soon.
Dr. Panagiotakopoulos explained that the statement is not aimed at any specific group. Much of the data is based on low reinfection rates during the first three months following an infection.
While some may contemplate delaying the vaccine, receiving it sooner than three months after your infection is possible.
Dr. Chu concurred with Dr. Shaw that the two months in one slide and three months in the other
are confusing. Should we instead change the three-month recommendation to “should receive
two doses of the age-appropriate vaccine spaced six months apart as close as three months
after the last” to align the language?
Dr. Fleming-Dutra clarified that the FDA determines this two-month minimum interval. Dr.
Kaslow said they would take this point of two- and three-month intervals between vaccination
and infection causing confusion under advisement.
Dr. Loehr motioned that ACIP recommends a second dose of 2024– 2025 COVID -19 vaccine for
adults 65 years of age and older.
Dr. Jam ieson seconded the motion.
Dr. Loehr motioned that ACIP recommends a second dose of 2024– 2025 COVID -19 vaccine for
moderately or severely immunocompromised people ages 6 months to 64 years.
Dr. Jam ieson seconded the motion.
36

  Dr. Loehr motioned that ACIP recommends additional doses (i.e., three or more doses) of 2024– 2025 COVID-19 vaccine for people ages 6 months and older who are moderately or
severely immunocompromised under shared clinical decision-making.
Dr. Jam ieson seconded the motion.
Ms. Hayes inquired whether the current vaccine is not 100% aligned with circulating strains of
the virus and whether data was available to speak to this.
Dr. Silk stated he does not have specific data from the lab but is told they are expected to
provide good protection given that they are subsets and the sublineages of the JN.1 strain.
Speaking on behalf of the American Geriatrics Society, Dr. Schmader expressed support for the
recommendation for an additional dose for those ≥65 years . The AGS also notes that a n
important population likely to benefit from additional doses that is not included in these
recommendations is nursing home residents younger than 65 years of age. This is something to
consider.
Dr. Hopkins commented that vaccines are the best defense against respiratory diseases, yet our vaccination rate remains below our goals. Less than 1 in 5 adults are concerned about Flu, COVID -19, or RSV. Only 38% shared they would get a Flu vaccine, and 26% would “definitely
get” an updated COVID vaccine. The concerns included side effects and distrust of vaccines in general. To address this problem, it’s necessary to directly address the concerns of side effects and safety .
Vote: COVID-19 Vaccines-Vote #1
Dr. Keipp Talbot (ACIP Chair ) read the following proposed ACIP voting language for COVID -
19 vaccines into the record:
In addition to previously recommended 2024-2025 vaccination: ACIP recommends a second dose of 2024-2025 COVID -19 vaccine for adults ages 65
years and older
Motion/Vote: COVID -19 Vaccines
Dr. Loehr motioned to approve the proposed vote recommendation for COVID -19 vaccines vote
#1, stating,” ACIP recommends a second dose of 2024-2025 COVID -19 vaccine for adults ages
65 years and older.”  Dr. Jamieson seconded the motion. No COIs were declared. The motion
carried with 15 favoring and 0 opposing. The disposition of the vote was as follows:
15 Favored: Asturias, Brewer, Brooks , Chen, Chu, Cineas, Jamieson, Kamboj, Kuchel,
Loehr, Maldonado, Moser, Schec hter, Shaw and Talbot
0 Opposed:
0 Abstained:
37

  Vote: COVID-19 Vaccines-Vote #2
Dr. Keipp Talbot (ACIP Chair ) read the following proposed ACIP voting language for COVID -
19 vaccines into the record:
In addition to previously recommended 2024-2025 vaccination:
ACIP recommends a second dose of 2024-2025 COVID -19 vaccine for people ages 6
months -64 years who are moderately or severely immunocompromised
Motion/Vote: COVID -19 Vaccines
Dr. Loehr made a motion to approve the proposed vote recommendation for COVID -19
vaccines vote #2, ”ACIP recommends a second dose of 2024– 2025 COVID-19 vaccine for
people ages 6 months -64 years who are moderately or severely immunocompromised.”  Dr.
Jamieson seconded the motion. No COIs were declared. The motion carried with 15 favoring
and 0 opposing. The disposition of the vote was as follows:
15 Favored: Shaw, Schec hter, Moser, Maldonado, Loehr, Kuchel, Kamboj, Jamieson,
Cineas, Chu, Chen, Brooks, Brewer, Asturias, Talbot
0 Opposed:
0 Abstained:
Vote: COVID-19 Vaccines-Vote #3
Dr. Keipp Talbot (ACIP Chair ) read the following proposed ACIP voting language for COVID -
19 vaccines into the record:
In addition to previously recommended 2024-2025 vaccination: ACIP recommends additional doses (i.e., 3 or more doses) of 2024– 2025 COVID -19
vaccine for people ages 6 months and older who are moderately or severely
immunocompromised under shared clinical decision-making
Motion/Vote: COVID -19 Vaccines
Dr. Loehr made a motion to approve the proposed vote recommendation for COVID -19
vaccines vote #3, ”ACIP recommends additional doses (i.e., 3 or more doses) of 2024– 2025
COVID -19 vaccine for people ages 6 months and older who are moderately or severely
immunocompromised under shared clinical decision-making.”  Dr. Jamieson seconded the motion. No COIs were declared. The motion carried with 15 favoring and 0 opposing. The
disposition of the vote was as follows:
15 Favored: Asturias, Brewer, Brooks , Chen, Chu, Cineas, Jamieson, Kamboj, Kuchel,
Loehr, Maldonado, Moser, Schec hter, Shaw and Talbot
0 Opposed:
0 Abstained:
38

 PUBLIC COMMENTS
The floor was opened for public comment on October 23, 2024, at 3:45 PM E ST. The comments
made during the meeting are summarized in this document. Members of the public were also
invited to submit written public comments to ACIP through the Federal eRulemaking Portal
under Docket Number ID CDC-2024-0072. Visit regulations.gov for access to read the
comments received.
Noah Louis-Ferdinand
Voices for Vaccines
Noah Louis -Ferdinand, communications coordinator for Voices for Vaccines, commented on
adding the high-dose flu vaccine to the V FC program for transplant recipients. He emphasized
the importance of protecting vulnerable populations, noting low vaccination rates among young,
healthy individuals. Many of his peers in their 20s are not enthusiastic about getting vaccinated, making additional options beneficial. He also expressed interest in the expanded pneumococcal vaccination recommendations, questioning how likely adults are to receive multiple vaccines in a year. He highlighted the importance of understanding the need for multiple vaccinations and
the potential barriers, such as time off for appointments and the possibility of feeling unwell
afterward. These public health considerations are crucial for effective implementation, even though the safety and efficacy of these vaccines are established.
Andrew Wang, PhD
Private Citizen
Andrew Wang thanked Dr. Talbot, the committee members, and the public for the opportunity to
share his comments. He highlighted ongoing concerns regarding the COVID -19 pandemic,
which still affects millions of Americans. He stressed the need for access to vaccines at least
twice a year for all individuals, regardless of health status, and urged the committee to revise
their policy questions accordingly. A restrictive approach to vaccination creates confusion and
discourages high-risk populations, including those under 65, from seeking necessary boosters.
He pointed out that public vaccine hesitancy will persist if the committee complicates vaccination criteria. Moreover, the vaccination schedule should address waning efficacy and new variants, aligning with the FDA’s approach. Ensuring biannual vaccine access will enhance protection against severe outcomes and align with CDC recommendations. He also emphasized
the need for equitable and affordable access to vaccines, especially after the end of the CDC’s Bridge Access program in August 2024, which left many uninsured with limited access . He
urged the committee to support no-cost access to COVID -19 vaccines to eliminate barriers and
improve public health.
Paul Hennessy
Unaffiliated Community Member
Paul Hennes sy said that the CDC must allow everyone to receive a second COVID -19 shot two
months after the first rather than limiting it to immunocompromised individuals. He requested
changes to voting language to broaden eligibility, as restricting access creates barriers and
limits protection. Additional shots have been proven effective and safe, and the CDC should
make sure this is covered by insurance while restoring the Bridge Access Program. Given the immune damage caused by COVID -19 in the population, all individuals need access to extra
doses.
39

 The CDC has noted spikes in cases during summer and winter, suggesting that low
transmission periods are not as low anymore—a more frequent vaccination strategy with
updated vaccine every six months is needed, rather than just in the fall. Waning vaccine efficacy should also be investigated. The ACIP should accelerate funding for intranasal COVID -19
vaccines and ensure H5N1 vaccines are available to all, especially farmers. Annual H5N 1
vaccinations alone will not suffice; preventative vaccines are essential for public health.
Edward Nirenberg
Unaffiliated Community Member
Edward Nirenberg thanked ACIP for the opportunity to speak. Despite advancements in other
areas, he expressed concern over the stagnation of influenza vaccine innovation. He noted that most available vaccines are ineffective against the H3N2 virus, partly due to egg-based
production methods. He urged increased support at the clinical trial, regulatory, and
manufacturing level to modernize influenza vaccines and highlighted the increasing public
discomfort with injections. He suggested that combining vaccine and mucosal -administered
options might be more acceptable. He supported the FDA's decision to allow caregiver and self-
administration of FluMist. He also discussed the durability of antibodies from current vaccines,
includi ng mRNA options, and advocated for making additional vaccine doses available. He
emphasized the need for clear communication regarding the risks and benefits for those
considering extra COVID -19 vaccines. He also noted that immunocompromised individuals want
additional doses but need help finding suitable vaccination environments, feeling uncomfortable in crowded, poorly ventilated pharmacies.
Timothy Cestaro
Unaffiliated Community Member
Timothy Cestaro thanked the group for the opportunity to share his concerns. As a father of four
boys, he reported that his first three children were vaccinated without issues. Still, his youngest
son suffered severe complications due to his pediatrician’s failure to follow safety protocols. He
worried about the lack of communication regarding vaccination safety for children with existing health issues. His son experienced severe allergic reactions and was diagnosed with eczema, which the pediatrician suggested was safe for vaccination. Despite being immunodeficient by CDC standards, the child received live vaccines at an early age and later had a febrile seizure after vaccination. He expressed concern that MMRV should not be given due to the risk of
febrile seizures. He also criticized the FDA for approving two vaccines that offer similar immunity when one has proven more dangerous, emphasizing that these decisions should not rest solely with parents.
Daniel Bessonov
Masks for All
Daniel Bessonov thanked the group for the opportunity to share his views. He strongly
encourages the CDC to recommend COVID -19 vaccines for all ages and health statuses,
advocating for at least two vaccinations annually . Full access to spring vaccinations is essential,
as the virus persists year -round and often surges. Immunity from vaccines wanes significantly
within 4 to 6 months, increasing the risk of infection and complications. Restricting vaccines based on age and health status leaves many unprotected, raising the chances of transmission. Regular updates to the vaccine are necessary to maintain effectiveness. He has faced
vaccination barriers due to his health, placing him at higher risk.
40

  The low vaccination rates compared to influenza are concerning. Continuous widespread
vaccination is crucial, as relying on infection immunity is risky. Frequent vaccination is vital to
prevent serious long-term health issues related to l ong COVID. The current vaccination
restrictions are confusing and may discourage people from getting needed boosters.
Corey Greenblatt, MPH
Global Healthy Living Foundation
Corey Greenblatt, representing the Global Healthy Living Foundation, expressed support for
vaccine access and public trust in their safety but raised concerns about specific RSV and PCV vaccine guidelines proposed by the committee. He hopes for revisions before finalization. The foundation advocates for individuals with chronic diseases, especially the most vulnerable, for whom vaccine access is essential. The recommended RSV vaccine for those aged 60 to 74
poses significant implementation challenges, particularly in community settings. The
requirement to confirm immunocompromised status may be hindered by inaccessible medical records. While the ACIP suggests patient attestation for risk factors, this can complicate the healthcare providers' decision-making process. Providers should not have to set aside their
clinical judgment. Aligning recommendations with FDA guidelines could help ensure informed
decision-making while maintaining patient safety. Additionally, the foundation urges routine PCV
recommendations for all adults over 50 to address alarmingly low pneumococcal vaccination rates.
RESPIRATORY SYN CYTIAL VIRUS (RSV) VACCINES -MATERNAL/PEDIATRIC
Dr. Helen Chu (ACIP, Work Group Chair) introduced the Respiratory Syncytial Virus (RSV)
section.  As of last year, there are now two forms of protection for infants against RSV. They are
maternal vaccine ( ABRYSVO
®, Pfizer) and n irsevimab (Beyfortus®, Sanofi & AstraZeneca). The
maternal vaccine is administered at 32- to 36 weeks gestation. Nirsevimab is administered to all
infants ≤8 months whose mother did not receive maternal vaccine. Only one of these products
is needed in most instances. Nirsevimab and maternal vaccines have different seasonal administration windows to provide optimal protection to the infant. The maternal vaccine is
typically administered from September through January. For infants born shortly before October
or during October through March who are not protected by the maternal RSV vaccine, immunize
within one week of birth, ideally during the birth hospitalization.
Dr. Anushua Sinha (Merck) presented on clesrovimab (MK -1654). Clesrovimab binds with high
affinity to RSV F protein site 4 with a highly conserved binding epitope. It has a low rate of
mutations detected within its binding site sequences. It has a high potency in vitro against various RSV clinical isolates and is equipotent against RSV -A and RSV -B. Three engineered
substitutions termed YTE result in an extended half-life. It achieves high nasal tissue distribution
and concentrations at sites of RSV infection.
The proposed indication is the prevention of RSV lower respiratory tract disease in neonates
and infants who are born during or entering their first RSV season with a proposed dose of 105 mg administered as a single intramuscular (IM) injection at the same dose to all infants
regardless of weight.
Protocol 004 was a Phase 2b/3 double-blinded, randomized, placebo-controlled study in healthy
preterm and full -term infants. The study's endpoints were the vaccine's safety, tolerability, and
efficacy against medically -attended lower respiratory tract infection due to RSV.
41

  Clesrovimab, administered as a single dose for infants of all weights, provides robust protection
against mild, moderate, and severe RSV disease for all healthy infants, including term and
preterm. Clinical data demonstrates over 90% efficacy in preventing RSV-associated lower
respiratory tract (LRI) hospitalizations through 6 months. Clesrovimab efficacy is durable across
all efficacy endpoints through 6 months. No shifting of RSV disease burden was seen in the
second RSV season. Clesrovimab is well tolerated in healthy preterm and full -term infants born
during or entering their first RSV season, and it has a safety profile that is generally comparable
to that of a placebo.
Protocol 007 is a Phase 3 multicenter, randomized, partially blinded palivizumab-controlled trial
conducted with active surveillance over 2 RSV seasons. The participants were infants at an increased risk for severe RSV disease. This is an ongoing study. The endpoints are safety, tolerability, and efficacy.
The safety profile of clesrovimab in infants at increased risk of severe RSV disease is generally
comparable to palivizumab and consistent with the safety profile in healthy infants. Efficacy in the Protocol 007 population was inferred from efficacy established in Protocol 004 among healthy infants based on comparable clesrovimab pharmacokinetic data. In infants at increased
risk for severe RSV disease, a single dose of c lesrovimab protects against RSV disease,
including RSV hospitalization, through 6 months.
In conclusion, clesrovimab, administered as a single dose for infants of any weight, provides
robust protection against mild, moderate, and severe RSV disease for all infants, including term, preterm, and those with risk factors. Clesrovimab is highly efficacious in healthy infants against
a broad spectrum of RSV disease endpoints, with no shifting of RSV disease burden in the
second RSV season (Protocol 004) —over 90% efficacy in preventing RSV LRI hospitalizations
through 6 months. Clesrovimab also protects infants at increased risk for severe RSV disease, comparably to palivizumab (Protocol 007).
Clesrovimab is well -tolerated in infants, with a safety profile generally comparable to controls
and consistent across infant populations. It is well tolerated in healthy preterm and full -term
infants born during or entering their first RSV season, and its safety profile is generally
comparable to that of placebo. The safety profile of clesrovimab in infants at increased risk for severe RSV disease is usually comparable to palivizumab and consistent with the safety profile in healthy infants.
Dr. Jamieson inquired whether it was possible to stratify efficacy by infant weight since the
conclusion was robust protection across all infant weights.
Dr. Sinha responded that the group conducted subgroup analyses, including one stratified by
weight. What was observed was that the stratified efficacy results were comparable and
consistent with the overall efficacy results. This can be shared with ACIP committee members.
Dr. Brooks requested the receipt of the data stratified by race and ethnicity.
Dr. Sinha confirmed this is available and will share it with the ACIP committee members.
Dr. Brewer stated for clarity that the primary outcome is medically -attended lower respiratory
tract infection (MALRI) with one or more indicators of LRI severity, while elsewhere, this is listed
as a secondary outcome. He also requested clarity on why the LRI hospitalization data looked
42

  similar. When looking at the all -cause data, there is a significant falloff in efficacy for the primary
outcome but none for hospitalization data.
Dr. Sinha confirmed that Dr. Brewer's statement was correct. The primary efficacy endpoint was
MALRI, which required at least one indicator of LRI/Severity with follow -up through five months.
One of the secondary endpoints was the same efficacy endpoint but with follow -up through six
months. She also confirmed that efficacy against LRI hospitalization due to any cause is 49%, reflecting the severity of this endpoint; this includes not just RSV determined by the pre-
specified endpoint but LRI hospitalization due to any cause. The MALRI endpoint is broad and
encompasses many diseases in clinics and hospitals.
Dr. Chu followed up on Dr. Jamieson's request. She would like to see the efficacy stratified by
gestational age and weight. She also requested to see the pharmacokinetic ( PK) data six
months out and whether there will be a faster or slower fall -off with different gestational ages or
birth weights.
Dr. Sinha confirmed that these data will be shared with the work group.
Dr. Schec hter asked whether PK or other data indicated the expected durability of protection
after the first season and whether primary and secondary event counts tended to occur later or
sooner after immunization. He also requested data on the durability of protection compared to
the timing of the injection and finally inquired whether there was a correlation of protection.
Dr. Sinha clarified that all efficacy points were collected through six months. These data are
available. A Kaplan-Mei er curve may be helpful to see that the efficacy is durable through the
entire six months. Cases were occurring across the entire 180-day period of follow up. There is
no formal correlate of protection.
Dr. Brewer was surprised by the outcomes and wanted to know whether additional outcomes
could have been reported within the presentation.
Dr. Sinha confirmed that all primary, secondary, and tertiary endpoints were reported in the
presentation.
Dr. Brewer shared a concern about data stability for post hoc analysis. It may be helpful to focus
on either a primary or a primary and secondary outcome. He is concerned about the
intensiveness of inspecting data across too many outcomes.
Dr. Malini B. DeSilva (Health Partners Institute) presented preliminary data about the RSVpreF
vaccine, preterm birth, and small for gestational age at birth preliminary results from the Vaccine
Safety Datalink (VSD). VSD is a collaborative project between CDC and 13 integrated healthcare organizations. It monitors the safety of vaccines used in the U.S., primarily through
observational multisite studies of rare and severe events following vaccination. VSD includes
data on ~15.5 million individuals across all sites annually, about 3.4% of the U.S. population. VSD reported an annual birth cohort of about 115,000 live births.
ACIP recommended Pfizer’s maternal RSV vaccine with seasonal administration (September to
January) for all pregnant women 32- 36 weeks gestation in September 2023. In clinical trials,
Pfizer’s maternal RSVpreF clinical trials identified an imbalance in preterm births in the
vaccinated group compared to the placebo group. Most were late preterm (34– <37 weeks),
occurred >30 days after vaccination, and occurred in a single country.
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  ACIP judged the benefits of the maternal RSV vaccine ( ABRYSVO ) at 32– 36 weeks’ gestation
to outweigh the potential risks for preterm birth and the hypertensive disorders of pregnancy.
The group evaluated preterm birth (<37 weeks gestation) and small for gestational age (SGA) at birth following maternal RSV vaccination. Most VSD sites started vaccinating in late October or
November 2023. SGA was defined as birthweight below the 10
th percentile for gestational age
and sex. In this controlled VSD study, Pfizer’s maternal RSVpreF vaccine was not found to be
associated with an increased risk for preterm birth or SGA at birth. Work is in progress on
analyzing acute safety outcomes, stillbirth, and hypertensive disorders of pregnancy
[preeclampsia, eclampsia, and HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets)].
Dr. Schec hter asked whether the study was limited to a single season or whether there were
plans for continued surveillance.
Dr. DeSilva confirmed there are plans to continue the study for this season. However, the data
presented is only for the first season.
Dr. Brewer requested an explanation of how to interpret preterm birth risk by gestation age at
vaccination from 32 to 36 weeks.
Dr. DeSilva commented that the team does not interpret this to mean that vaccination is
protective for preterm birth. The trend is similar in both of the groups.
Dr. Joseph was reassured that maternal immunization is a safe strategy for protecting infants against RSV. However, the analysis does highlight two points. Overall, the maternal vaccination rate was low, and the licensure data included patients vaccinated earlier than 32 weeks gestation. This is different from the approved dosing window. Given the implementation challenges, she inquired whether the work group plans to look at data from other surveillance systems like the United Kingdom to help inform the risk of preterm birth.
Ms. Moulia stated that she thought that the UK started maternal RSV vaccination in September
2024 and that the work group c ould review data from the UK when available.
Dr. Asturias requested clarification on the RSV groups, including whether there were any
exclusions and whether the vaccinated and unvaccinated groups were similar.
Dr. DeSilva shared that vaccinated and unvaccinated people have similar characteristics.
However, there are some imbalances including for race, ethnicity, and age.
Ms. Danielle Moulia (CDC/NCIRD) reviewed the maternal and pediatric RSV work group’s
interpretations and next steps. The policy question being considered is whether clesrovimab
should be recommended for all infants <8 months of age entering their first RSV season or born during the RSV season.  Initial efficacy and safety data look promising; however, the work group has requested additional pharmacokinetic, efficacy, and safety data from the manufacturer. The work group also highlighted that clesrovimab had demonstrated a shorter half-life than
nirsevimab (42 vs. 71 days), the COVID -19 pandemic disrupted the trial enrollment period, and
clesrovimab and nirsevimab trial outcomes had different definitions. Overall, the work group felt
that the initial data merited moving forward with the evidence review for the policy question.
44

  Future evidence to be reviewed by the work group includes additional data on Phase 2b/3 and
Phase 3 studies, GRADE of evidence, cost-effectiveness analysis, and the EtR framework. It is
projected to be presented at the February 2025 meeting, with an ACIP vote possibly as early as
the June 2025 meeting, depending on FDA licensure.
Data were summarized on the preliminary findings from the first season of maternal RSV
vaccine administration in an SD study that found that maternal RSV vaccine during 32– 36
weeks’ gestation was not associated with an increased risk of preterm birth or sm all for
gestational age. The work group felt that messaging about potential risks for hypertensive
disorder of pregnancy should be separated from preterm birth. Some work group members felt that when counseling on maternal RSV vaccination at 32– 36 weeks, messaging on potential
risks of preterm birth could be softened, or counseling no longer needed to include discussion regarding a possible risk of preterm birth. CDC and FDA will continue to monitor safety data for
maternal RSV vaccine, including further VSD analyses for hypertensive disorders of pregnancy.
Dr. Shaw asked whether the preterm birth rates reported in this study were low or within the
expected range and if any more was known about the preterm birth signal seen in GSK’s clinical trial.
Dr. DeSilva responded that preterm birth rates in the population and the SGA at birth were in the
expected range for the VSD.
Dr. Jones addressed the second question and said there was not a clear biologic explanation.
Dr. Schec hter encouraged committee consideration for language encouraging the speedy
implementation of nirsevimab in birth hospitals.
Ms. Moulia noted that the current guidance is that infants born shortly before or during the RSV
season should be immunized within one week of birth, ideally during the birth hospitalization.
CDC is organizing learning collaboratives to share promising practices for nirsevimab
administration in birthing hospital s.
Dr. Chatham -Stephens followed up with additional information. CDC is working closely with the
immunization programs to enroll more birthing hospitals into the Vaccines for Children Program
and offering specialized technical assistance to awardees. Some jurisdictions received site
visits, focus groups, and key informant interviews. In early August, the CDC held a perinatal and
maternal reverse site visit, during which many immunization program managers from across the country also came to discuss these issues.
Ms. Hayes expressed her appreciation for the review of data on vaccinating pregnant women,
which shows that vaccination in this group is safe.
Dr. Brooks moved the meeting to recess and reconvening on October 24, 2024, at 8:00 am
.
With no additional business posed for the day, the ACIP meeting stood in recess until 8:00 AM
on October 24, 2024.
45

  THURSDAY : OCTOBER 24, 2024
WELCOME AND INTRODUCTIONS
Call to Order/Roll Call
Dr. Keipp Talbot (ACIP Chair) c alled to order and presided over the October 24, 2024, Advisory
Committee on Immunization Practices (ACIP) meeting. She then conducted a roll call , which
established that a quorum was present. A list of Members, Ex Officios , and Liaison
Representatives is included in the appendixes at the end of this summary document. No COIs
were identified for the second day of this meeting.
AGENCY UPDATES
Center
s for Medicare and Medicaid Services (CMS)
Ms. Mar
y Beth Hance shared that they have worked hard to amplify CDC and HHS messaging
around the importance of seasonal and routine immunization. They have talked to state
Medicaid agencies and interested parties at many touchpoints throughout state connections and
community involvement. They have appreciated the efforts of representatives from the CDC speaking with state Medicaid agencies to emphasize the importance of immunization and continue to return to the higher pediatric immunization rates seen in previous years. She also highlighted that on September 12, 2024, her colleagues issued a Medicare learning network bulletin that included COVID codes and pricing for this year’s COVID -19 vaccine codes and
pricing for this year’s vaccine.
Cent
ers for Disease Control and Prevention (CDC)
Dr
. Demetre Daskalakis thanked colleagues at the FDA, industry, and ACIP for an expeditious
rollout of COVID -19 vaccines. COVID -19, Influenza, and RSV are all available and in the field.
There have been interesting changes seen by launching earlier in the year. We have seen a higher uptake of the COVID-19 vaccine during this time of year compared to last year's same date. This is a testament to the close collaborations across the various components of government and industry. The number of respiratory illnesses in the U.S. continues to be low. COVID -19 activity continues to decline in all areas. As expected, there is minimal seasonal flu
and RSV activity in the southeastern part of the U.S. It tends to start in this area and then sweep across the country.
He flagged the number of measles cases seen. As of October 10, 2024, 32 jurisdictions
reported 267 measles cases. There have been 14 outbreaks reported in 2024, and 70% of
cases are outbreak -associated. For comparison, four outbreaks were reported during 2023, and
49% of cases were outbreak -associated. Jurisdictions at the highest risk for measles outbreaks
continue to be those with communities with persistently low MMR vaccination coverage and
importations from international locations with measles outbreak s.
He also highlighted that respiratory infections caused by Mycoplasma pneumoniae have
increased in the United States since last spring among all age groups, particularly young
children. Healthcare providers should consider M. pneumoniae as a cause of pneumonia and
test when indicated. Macrolides are the first-line treatment for this infection; some first-line antibiotics used to treat pneumonia, like penicillin, will not treat M. pneumoniae.
46

  He shed light on the Vaccines for Children Program for its 30th anniversary. With the
intervention, 508 million illnesses and 1.29 million deaths in children will be prevented, saving
2.7 trillion in societal costs.
Food and Drug Administration (FDA)
Dr. David Kaslow shared that since the last FDA Agency report at the June 2024 ACIP meeting,
our Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened twice
and plans to meet again before yearend. The Office of Vaccines Research and Review took
several noteworthy supplemental regulatory actions.
In September, VRBPAC met in an open session to discuss considerations related to using
pertussis Controlled Human Infection Models (CHIMs) to demonstrate the efficacy of pertussis
vaccine candidates for licensure. Two endpoints were discussed: mild disease such as cough,
and colonization. Considerations on using these models included their relevance to pediatric
populations, their limitations with real -world pertussis infection and disease, and the ability to
assess the long-term effectiveness of pertussis vaccine candidates.
In October, VRBPAC also convened in an open session to make recommendations on influenza
vaccine strains for the 2025 influenza season in the Southern Hemisphere and discuss pandemic preparedness for highly pathogenic avian influenza virus, including considerations for vaccine composition for (H5) vaccines. The FDA proposed an Inter -Pandemic Period Strain
Change Process to use the inter -pandemic period to accrue additional safety and
immunogenicity evidence with updated prototype vaccines and potentially save critical
pandemic response time to have updated vaccines when needed.
FDA also anticipates a VRBPAC meeting on December 12th to discuss considerations for RSV
vaccine safety in pediatric populations.
On 19 August, the meningococcal B vaccine, BEXSERO, with a dosing schedule in individuals
10- to 25 years of age of two doses administered at 0 and ≥1 month under accelerated approval
was revised to two doses administered at 0 and 6 months, and to include a three-dose schedule
of BEXSERO administered at 0, 1-2, and 6 months for the same age group, now under
traditional approval.
On 29 August, Smallpox and Mpox (Vaccinia) Vaccine, Live, ACAM2000
®, was approved to
include mpox disease prevention in individuals at high risk for mpox infection. It was approved
with an updated medication guide.
Finally, on Tuesday this week, the RSV vaccine ABRYSVO was approved to prevent lower
respiratory tract disease caused by RSV in individuals 18-59 years of age who are at increased
risk for lower respiratory tract disease caused by RSV.
47

  Health Resources and Services Administration (HRSA)
CDR Paul McClung shared that t he Division of Injury Compensation Programs (DICP ) continues
to support the Nation’s public health through the administration of the National Vaccine Injury
Compensation Program (VICP ) and the Countermeasures Injury Compensation Program
(CICP ). As a part of this support, HRSA, in partnership with the Centers for Disease Control and
Prevention (CDC), sponsored a study from the National Academy of Sciences, Engineering, and Medicine (NASEM) to review the evidence from 19 potential harms of COVID -19 vaccines and
nine (9) potential shoulder injuries from intramuscular administration of vaccines more broadly. The NASEM committee drew 65 conclusions where it could not find evidence to establish, accept, or reject a causal relationship and drew 20 conclusions with sufficient evidence, with the final release of the report in August 2024. The important conclusions drawn by the committee will support decision-making for VICP and CICP when adjudicating compensation claims.
In support of VICP, the Advisory Commission on Childhood Vaccines (ACCV ) was briefed on
the NASEM report on July 11, 2024. ACCV made motions to establish a workgroup to amend
the Vaccine Injury Table’s Qualifications and Aids to Interpretation (QAI) to address conclusions and information provided by NASEM on shoulder injuries. They also added an agenda item to
the next ACCV meeting, with input from HRSA/HHS, about potential research areas of interest regarding shoulder injuries.
ACCV currently has several vacancies and is seeking nominations. Additional information is
available on the ACCV website. If you have questions or want to submit a nomination, please
visit our website or email ACCV@hrsa.gov .
VICP is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.
It was created in the 1980s after lawsuits against vaccine companies and healthcare providers
threatened to cause vaccine shortages and reduce U.S. vaccination rates. VICP continues to serve as a keystone program in the Nation’s ability to stabilize vaccine supply and protect the
Nation’s public health by expeditiously processing claims.
Over the past two fiscal years, VICP has made substantial strides in reducing the backlog of
claims awaiting review by an HRSA provider.  From October 2022 to October 1, 2024, VICP has
reduced the number of claims activated by the U.S. Court of Federal Claims from 1,107 to
166. Over this same period, the waiting times for a HRSA medical review have decreased from
more than 12 months to 49 days.  In FY2024, VICP received 1,161 petitions, adjudicating 1,374
claims and awarding over $149 million to petitioners and over $53 million for attorney’s fees and
costs.
CICP is also a no-fault compensation program. CICP adjudicates requests for benefits alleging
an injury from covered medical countermeasures deployed in response to a pandemic,
epidemic, or security threat covered under a Public Readiness and Emergency Preparedness Act declaration by the Secretary of Health and Human Services. As of October 1, 2024, 13,468
claims alleging injuries/deaths from COVID-19 countermeasures had been filed with the CICP.  CICP continues to make substantial progress in processing claims and has now rendered
decisions on 3,318 COVID-19 claims.
48

 In August 2024, the Bureau of Primary Health Care (BPHC) released its Uniform Data System
(UDS) data. The UDS captures the immunization rates for children two years of age and under
based on the CDC10 series. BPHC is actively collaborating with CDC to promote immunization
efforts across the spectrum by promoting various tools and resources that CDC has developed
through different communication channels.
HRSA’s HIV/AIDS Bureau also continues its important work through the Ryan White HIV/AIDS
Program, which continues to support access to mpox vaccination.
Indian Health Services (IHS )
Dr. Matthew Clark shared that the Indian Health Service remains committed to immunization as our leading clinical and public health prevention priority. As part of our ongoing national E3
vaccine strategy, IHS offers every ACIP -recommended vaccine when appropriate to every
patient at every encounter. HIS has designated 32 E3 pilot sites in 9 IHS Areas, including
federal, tribal, and urban Indian organization teams.
The IHS E3 Vaccine Strategy continues to bear fruit as pilot sites innovate at the local level and
share best practices regarding effective immunization strategies in tribal communities to cross -
pollinate our system of care. This year, five IHS E3 Champions have been designated in the
Alaska, Bemidji, Great Plains, Nashville, and Oklahoma City Areas. Each has demonstrated
excellence by exceeding established thresholds to improve vaccine coverage rates for AI/AN people.
Over the last several months, we have been developing E3 training materials for an academic
detailing activity. This week, six healthcare professionals representing federal, tribal, and urban
Indian organization programs are undertaking intensive training to become E3 ambassadors in
their respective a reas. Following completion of training, they will undertake outreach to educate
and support immunization staff working in tribal communities in implementing the IHS E3
Vaccine Strategy.
Following ACIP action in June of this year related to a preferential recommendation for the
hexavalent vaccine VAXELIS
® in AI/AN infants , through a variety of platforms including written
guidance and both in-person and virtual events, IHS has been working diligently to communicate this option to vaccination teams serving tribal communities. We plan to monitor
the impact of this recommendation on vaccine coverage rates and potential ly disease
outcomes.
Finally, IHS is actively engaged in its annual seasonal vaccination campaign to reduce the risks
of vaccine-preventable respiratory viral diseases in Indian Countr y, including influenza, COVID,
and RSV. This includes aggressive efforts to promote access to and uptake of both maternal
RSV vaccine and nirsevimab among AI/AN infants and young children. Like last year, in addition to collaboration with the Vaccines for Children program, IHS procured and distributed a supplemental supply of nirsevimab to support programs, especially those in remote locations,
with planned early -season vaccination activities. This year, IHS has also worked closely with
federal partners at the CDC and the Administration for Children and Families (ACF) to develop
materials and provide education to support home-based outreach to Indigenous families about
the importance of recommended RSV immunizations.
49

  Working in collaboration with our federal, Tribal, and Urban Indian organization partners, the
Indian Health Service will continue our efforts to mitigate the risk of vaccine-preventable illness
in Indian Country.
Office of Infectious Disease and HIV/AIDs Policy (OIDP)
Dr. Chinedu Okeke shared that t he National Vaccine Advisory Committee (NVAC) met on
September 12-13, 2024. At this meeting, the committee showcased work that can help to
strengthen the U.S. vaccine and immunization system and inform vaccine policy. The meeting
began with a panel presentation on implementing the ACIP universal vaccine recommendation for adults aged 19- to 59 years of age and adults aged 60 years of age and older with known
risk factors for hepatitis B. The committee also heard presentations on provider payment and RSV immunization across lifespan.
Much of the discussion at this meeting also focused on innovation to provide additional context
for the report the committee is currently working on. NVAC hosted speakers on tuberculosis vaccine innovation and some challenges of advancing the tuberculosis vaccine pipeline. It also
hosted a panel on new research to inform future HIV vaccine development.
On the first day of the meeting, we learned more about a new HHS campaign called Risk Less.
Do More. NVAC also hosted two panels focused on immunization equity. The first panel
showcased two innovative projects, and the second panel explored lessons and evaluation
approaches. To fulfill the charge of providing input to advance the development of the Vaccine National
Strategy , the committee participated in two working sessions to discuss potential
recommendations for new goals, indicators, and objectives.
In collaboration with the HHS Interagency Vaccine Work Group, OI DP has started planning,
data gathering, and engagement efforts for the next iteration of the National Vaccine Strategic
Plan for 2026-2030. OIDP has posted the Request for Information for the public on the Federal
Register, and the 60-day countdown has begun. Everyone is encouraged to provide feedback
on all the strategies. We encourage ACIP members to actively submit feedback and
recommendations during this process .
OIDP is putting together several virtual and in-person sessions. The first listening session will
occur on October 29 from 2 to 3:30 PM ET. The second opportunity is a vaccine strategy -
focused listening session on October 31 from 1 to 2:30 ET. In November, OIDP will host two
general sessions for all the National Strategic Plans on November 13 and November 14
(Spanish language) from 2 to 3:30 ET.
OIDP continues to lead the "Summer of Pride" Mpox Equity Initiative, a nationwide effort to increase access to mpox vaccines for communities most at risk. This initiative leverages Pride festivals and other events to reach these communities effectively .
50

  On September 4th, OIDP and the HHS Office of Intergovernmental Affairs organized a virtual
stakeholder call for community partners. This call served as a continuation of OIDP's previous
discussions this year with community partners and health department staff involved in the mpox response. The stakeholder call, led by Assistant Secretary for Health ADM Rachel Levine and
CDC Director of the National Center for Immunization and Respiratory Diseases Demetre Daskalakis, provided an update on the Clade 1 mpox virus and the U.S. preparedness and response. OIDP is currently planning another stakeholder call for November.
National Institute of Health (NIH)
Dr. John Beigel shared that NIAID is sponsoring a Phase 1 trial testing the safety of an
experimental nasal vaccine for SARS -CoV -2. The vaccine utilizes a new virus vector, murine
pneumonia virus, related to human RSV. Scientists at the NIH/NIAID Laboratory of Infectious
Diseases designed and tested it in pre-clinical studies. This is part of Project NextGen, a
program in both BARDA and NIAID that aims to accelerate the development of next generati on
COVID -19 vaccines .
For m pox, NIAID sponsored a clinical trial of the MVA- BN mpox vaccine in adolescents,
demonstrating that it is safe and generated an antibody response equivalent to that seen in adults. Adolescents are among the population groups affected by mpox in the current outbreak in the DRC. Bavarian Nordic received EMA approval to extend the MVA -BN authorization to
include adolescents.
As part of the U.S. government’s response to the current mpox outbreak, NIAID has updated its
priorities for mpox research. The NIAID mpox research agenda includes objectives to respond
to the mpox outbreak including trials to evaluate ways to stretch the vaccine supply, and to
develop novel vaccines and therapeutics.
For m alaria, two NIH -supported trials of a novel malaria vaccine in healthy adults in Mali found
that all regimens were safe and generated a robust immune response. The vaccine candidates
conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over two years without the need for a ny booster dosing.
For RSV, NIAID is conducting a randomized, open-label Phase 4 s tudy of maternal RSV
vaccination compared to infant n irsevimab or both products combined. The trial opened to
enrollment in September 2024 and evaluates antibody titers for one year, which is expected to
inform clinical use of these products.
NIAID has named Sarah W. Read, M D, MHS, as the Principal Deputy Director for the institute
following Dr. Hugh Auchincloss’s retirement in September 2024.
NIH has established the Research and Development of Vaccines and Monoclonal Antibodies for
Pandemic Preparedness network —called ReVAMPP — to focus on “prototype pathogens” to
develop vaccine candidates and monoclonal antibodies to better protect against emerging
pathogens . By studying specific prototype pathogens, scientists will build a knowledge base that
could be applied to future emerging viruses.
51

  MENINGOCOCCAL VACCINES
Dr. Jamie Loehr, chair of the ACIP Meningococcal Vaccines Work Group, introduced the
meningococcal vaccines session. The work group is working on three main topics. The work group is reviewing GSK ’s pentavalent MenABCWY vaccine, with a regulatory decision expected
by February 14, 2025, and anticipating a vote on this topic in February 2025. The work group
also has discussed the newly approved interval and dosing change for MenB -4C ( BEXSERO),
with a vote planned for this meeting. The work group also is continuing its review of the
adolescent meningococcal vaccine schedule and expects a vote in 2025.
From 1996- 2023, meningococcal disease cases dropped by 90%. There are 0.13 cases per
100,000 population (1 in a million cases). This drop is primarily attributed to serotypes B, C, and Y. There was an increase in cased due to serogroup Y in 2023. During 2012-2021, many of the
cases were seen in the elderly and age group <1 year, but current policy discussions are focused on the age groups 11-15, 16-20, and 21-25 years of age.
Dr. Xiaoyu Dong (CDC/NCIRD) presented the results of the economic analyses of GSK (MenABCWY) vaccine among adolescents in the U.S. The goal for the economic analysis was
to evaluate the effectiveness of vaccinating adolescents with the GSK pentavalent vaccine (MenABCWY) compared to the current recommendation of the MenACWY/MenB vaccine. The current recommendation is MenACWY vaccine (Q): 1st dose at 11– 12 years; 2nd dose at 16
years. In addition, ACIP recommends MenB vaccine (B): 1st and 2nd dose at 16– 23 years
(preferred 16– 18 years), based on shared clinical decision- making.
Three policy questions (PICO s) are under consideration.
1. PICO 1: Should the pentavalent vaccine (P, MenABCWY) be included as an option for
MenACWY/MenB vaccination in people currently recommended to receive both vaccines
at the same visit? (Q -P-B)
2. PICO 2: Should the pentavalent vaccine be included as an option for people currently
recommended to receive MenACWY only? (P -P)
3. PICO 3: Should the pentavalent vaccine be included as an option for people currently
recommended to receive MenB only? (Q -P-P)
The intervention was the use of pentavalent in adolescents compared to current
recommendations or related strategies. For reference, each strategy was compared to no
vaccination. The economic model included the entire cohort of current 11-year -olds in the U.S.
Vaccination costs and meningococcal cases were assessed for 19 years. Costs and health outcomes of meningococcal cases were evaluated from age 11 years through the participant’s
entire lifetime. The analysis was from the societal perspective and a 3% discount rate was
applied.
Invasive meningococcal disease (IMD) rates among unvaccinated individuals were based on
observed rates from 2003-2005 for serogroups ACWY and from 2012-2014 for serogroup B.
Case fatality rates were estimated at 15.4% for serogroups ACWY and 9.4% for serogroup B.
Some of the sequelae of IMD include hearing loss, skin scarring, neurologic disability, and
single and multiple amputations. Vaccine efficacy was estimated at 79% for the first Q dose and 99% for the subsequent doses and 64% for the first dose of B and 79% for the second, with
waning over time for all doses. In PICO 1, the intervention P is introduced as an alternative to QB. In PICO 2, P doses were introduced to replace current Q doses.
52

  In PICO 3, P replaced the B dose. The vaccine cost per dose (including administration) $177 for
Q, $224 for B, and $245 for P.
The model estimated that without vaccination, there would be an estimated 233 IMD cases and
33 deaths. The two vaccination strategies in PICO 1 yielded identical outcomes, with 142 IMD
cases and 19 deaths. In PICO 2, the main difference between the compared strategies was the
protection that P doses offer against serogroup B, which prevented an additional 12 IMD cases and one death. In PICO 3, the difference in health outcomes comes from the last dose in each strategy. The final dose of P in the Q -P-P will prevent one additional IMD case compared to
using B as the last dose. Both Q-P-B and Q -P-P were cost -saving compared to Q -QB-B.
However, compared to no vaccination, the cost per QALY gained was high for all vaccination
strategies (>$2M per QALY).
Dr. Dong provided a summary comparison of GSK’s model to the CDC model.  GSK’s model used a higher incidence and coverage rate than was used in CDC’s. The initial VE for 1
st dose
MenB was 64% in the CDC model compared to 33.5% in GSK’s model. In CDC’s model, VE
declined to 0% in 5-10 years compared to 0% after more than 20 years in GSK’s model. CDC’s model included five sequelae outcomes with an aggregate probability of 22%, while GSK’s
model included 16 sequelae outcomes with an aggregate probability of 55%. Both models
showed cost -saving for PICO 1. The GSK model showed a higher ICER than CDC’s models for
PICO 2. Both models showed cost-saving in PICO 3 when the intervention was compared to Q -
QB-B.
The study had limited VE data, assumptions on the third dose effectiveness of MenACWY, unknown pre-vaccination incidence rates, and estimated costs for GSK’s pentavalent vaccine. The study also did not account for additional protection against gonorrhea, the potential
increase in vaccine uptake, or benefits from fewer adverse events from reduced injections. The
CDC model used vaccine coverage data based on the current shared clinical decision-making
practices and did not model any changes to the routine use of MenB vaccines.
Dr. Dong summarized that Q -P-B was cost -saving relative to the current recommendation (vs.
Q-QB -B). P- P could improve health outcomes but costs $11.3 million per QALY saved (vs. Q -Q).
Q-P-P could improve health outcomes, but estimated economic value varied depending on the
comparator. Q -P-P is cost -saving compared to Q -QB-B, but compared to Q-P-B, it costs $4.5
million per QALY gained.
Dr. Maldonado was surprised that the work group would choose to give a vaccine at three
different times rather than a pentavalent vaccine, which we would only have to give twice,
especially in a population like adolescents, who are very hard to bring back. She was curious
how retaining an adolescent three different times would not impact efficacy. She questioned how 2 doses of a broader vaccine (i.e., pentavalent vaccine) would be least cost-effective and whether the vaccine cost drives this decrease. She also inquired whether P -P can be compared
to Q-QB-B.
Dr. Dong clarified that Dr. Maldonado is speaking on PICO2, in which P -P is compared to Q -Q.
Within this comparison, the travel trips would be the same: one trip for the first dose and another
for the second. When the incremental cost-effectiveness ratio is calculated, the advantage of
having fewer trips would be canceled. The study is limited when comparing P -P trips to other
strategies. She also clarified that P-P was not compared to Q -QB-B because it was not one of
the PICO questions, but there would be a reduced trip in this comparison.
Dr. Leidner stated that if there is an additional request to compare P-P to Q -QB-B, the
economics team would gladly do so.
53

 Dr. Schechter questioned whether the comparison of Q-P-P vs. Q -QB-B in PICO 3 would be
comparable with other pentavalent formulations already available.
Dr. Dong shared that PICO 1 is cost -saving because the net health outcome is the same.
Overall, cost -saving occurs because P is less than the cost of QB. In Q -P-P vs. Q -QB-B, Q -P-P
is cost -saving because the last dose of P protects against serogroup ACWY. The difference
between P and QB makes the price lower. Dr. Leidner added that if Dr. Schechter was referring to the pentavalent vaccine that is already in
use, the results from this analysis, which was done presented June 2023, were similar, and it
was also cost -saving.
Dr. Schechter inquired if the baseline risk was lower than before the availability of vaccines and
whether this would be associated with increased cost estimates. He also asked about the vaccine coverage inputs in the model ; for the Q -P-B model, was their overlap between the
27.3% receiving Q and the 32.4% receiving P?  He also asked what impact a coverage lower
than 59% would have on cost-effectiveness.
Dr. Leidner confirmed that if the disease risk is lower, the disease burden would be lower, and
there would be less disease to prevent with the use of vaccines. Therefore, the cost-
effectiveness ratios could increase. In this scenario, if a person was using shared clinical
decision-making after they got their second Q, they went on to get their B series. Those who did
not choose to get the B vaccine still got the Q vaccine to finish their Q series. He also stated that a lower coverage simulation was not run, but this is also something the team could investigate in the future.
Dr. Shaw requested confirmation that the P-P intervention would prevent the need for a second
B vaccine. In this case, comparing P -P to Q -QB-B would be relevant.
Dr. Dong responded that this simulation was not included in the model, and Dr. Leidner added that it would be brought back to the team to develop this comparison.
Dr. Loehr requested that the committee consider that we are only looking at hundreds of cases
vs other diseases that result in thousands of cases. Regarding the cost analysis, PICO 1 is cost -
saving because the manufacturer has priced it so that MenACWY might be $180 and Men B
would be $180, but combined, they are only $220. The pentavalent vaccine is much less
expensive than the two vaccines combined, resulting cost-saving compared to separate
administration. He reminded the group that the ACIP has decided on shared clinical decision-
making for MenB vaccine at the current time, so many people get Q -Q without B -B. He
emphasized that the ICER is in millions, not thousands , of dollars per QALY . Many other ACIP-
like o rganizations will not consider ICERs over $100,000 to $150,000 per QALY gained. He
wants the group to know that we are contemplating spending a lot of money on very few cases. He recognizes this is a dramatic, devasting disease for those who get it but would like to
consider fiscal prudence. He suggest ed that the manufacturers heed the concern that vaccine
prices are becoming too expensive for him as an ACIP member to contemplate.
Ms. Moser added that cost is only one part of the work group's consideration. This disease kills
1 to 2 of 10 people that it infects and permanently disables half of those who survive; the
committee has to take into account the costs beyond the economic costs. The models are
sensitive to changes in inputs and so there is uncertainty about what will actually happen, if a recommendation is made.  She also shared that there are a variety of points of view within the committee.
54

    Dr. Middleman called for action regarding pharmaceutical companies' high vaccine costs. She
also added that the vaccine recommendation is confusing and should be simpler and more
concise.
Dr. Sarah Schillie (CDC/NCIRD) discussed the Evidence to Recommendations Framework
(EtR), which includes GRADE for the GSK Pentavalent (MenABCWY) vaccine. As a review, the
current routine schedule includes one MenACWY dose at age 11-12 years and a booster at 16 years. Two MenB doses at age 16-23 years (shared clinical decision-making [SCDM]). The
MenACWY vaccine is also recommended for persons at increased risk, including some
microbiologists, those exposed during an outbreak, those traveling to hyperendemic areas, first -
year college students (if not already vaccinated), and those with some health conditions such as asplenia, complement deficiency , complement inhibitor use, or HIV infection. MenB is also
recommended for persons at increased risk, including some microbiologists, those exposed during an outbreak, and those with some medical conditions, including asplenia, complement deficiency, and complement inhibitor use. MenACWY vaccines are interchangeable, but MenB vaccines are not.
There are two new MenABCWY vaccines. Pfizer manufactured Penbraya, which ACIP voted on
in October 2023. GSK manufactures the other and is anticipating an ACIP vote in February
2025. Each vaccine is a combination of an existing MenACWY and an existing MenB vaccines.
Both vaccines are intended to be administered as two doses separated by six months and
indicated for persons 10- 25 years of age. The ACWY component in the Pfizer vaccine is
Nimenrix, while in the GSK, the component is Menveo. The B component in the Pfizer vaccine is TRUMENBA
®, and BEXSERO in the GSK.
The policy questions for GSK’s pentavalent vaccine mirror those previously used for the Pfizer
vaccine and are as follows:
• Should the GSK pentavalent vaccine be included as an option for MenACWY/MenB
vaccination in people currently recommended to receive both vaccines at the same visit?
• Should the GSK pentavalent vaccine be included as an option for people currently
recommended to receive MenACWY only?
• Should the GSK pentavalent vaccine be included as an option for people currently recommended to receive MenB only?
The critical outcomes included meningococcal disease caused by serogroups A, B, C, W, and Y,
short-term immunity, and serious adverse events. PICO 1 translates to the schedule option Q -P-
B, PICO 2 to the schedule option P -P-B, and PICO 3 to the schedule option Q -P-P.
Dr. Schillie began the discussion of the EtR domains with the public health problem. Invasive
meningococcal disease (IMD), which often presents as meningitis or bacteremia, progresses
rapidly. It affects previously healthy young people, and 10-15% of cases are fatal even with
antibiotic therapy. About 20% of survivors experience long-term sequelae. The work group felt
that IMD is an important public health problem for all three PICOs.
Seven trials were included for evidence review for benefits and harms. Included studies were
randomized trials; all except one were blind to the observer. Four studies contributed to assessing short-term immunity one month after one MenACWY vaccine dose in healthy persons. The seroresponse risk ratio ranged from 0.94 to 1.03 for serogroups A , C, W, and Y.
The certainty was deemed moderate. For persons at increased risk, the certainty estimate was further downgraded for indirectness and the certainty was low. The certainty of evidence for
short-term immunity after series completion was similar to that found following one dose.
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  No studies informed long-term immunity for the MenACWY vaccine. One study informed long-
term immunity assessed at two years for MenB vaccine . The overall certainty level was low for
healthy people and very low for people at increased risk.
Seven studies informed adverse events. Serious adverse events related to vaccination occurred
among three subjects who received the pentavalent vaccine compared to one who received the
MenACWY vaccine and two who received the MenB vaccine. The certainty was rated moderate for healthy people and low for people at increased risk. For non-serious adverse events for healthy people, the certainty level ranged from moderate to high, with low to moderate certainty levels for people at increased risk.
In summary, for PICO 1, evidence for meningococcal disease caused by serogroups A, B, C, W,
and Y and interference with other vaccines administered concurrently is lacking. Evidence for
short-term immunity for ACWY and B serogroups is moderate and low for healthy persons and
persons at increased risk, respectively. Evidence for serious adverse events is moderate and low for healthy people and people at increased risk, respectively. Similarly, evidence for nonserious adverse events is moderate and low for healthy people and people at increased risk, respectively. Evidence for persistent immunity is only available for MenB serogroups and is low and very low for healthy persons and persons at increased risk, respectively. The summary is
similar for PICO 2 and 3, but the evidence lacks informing persistent immunity for MenACWY
serogroups , affecting PICO 2.
The work group felt that the desirable anticipated effects are small for all three PICOs. The
undesirable anticipated effects are minimal for PICOs 1 and 3 and small for PICO2. For PICO 1,
the work group felt the intervention was favored but varied for PICO 2 and 3. The overall
certainty of evidence for short-term immunity was moderate or low for the three questions , and
the overall certainty of evidence for serious adverse events was moderate or low for the three
questions.
For the values domain, in 2023 about 85% of 13-year -olds received at least one MenACWY
vaccine dose, and approximately 60% of 17-year -olds had at least two doses , and about 32%
and 13% of 17-year -olds received at least one or two doses of MenB vaccine, respectively.
Additionally, almost 90% of 16- to 23 -year-olds and 69% of their parents indicated they would
prefer a simplified vaccine schedule, with fewer injections and fewer visits . The work group felt
that the target population would feel that the desirable effects were large relative to the
undesirable effects for PICO 1, were probably large for PICO 2, and were large or probably
large for PICO 3. This is similar to the work group’s rating for the Pfizer pentavalent vaccine.
The work group felt that there was probably not or was not important uncertainty or variability in
how much people value the primary outcome for PICO 1. There was more uncertainty for PICO
2 and 3, similar to the ratings for the Pfizer pentavalent vaccine.
For acceptability, the CDC’s General Best Practice Guidance for Immunization and the American Academy of Pediatrics Red Book both state a general preference for combination
vaccines over separate injections of equivalent component vaccines. Adolescents prefer fewer
injections due to injection site discomfort, and parents/caregivers prefer fewer injections to reduce the number of physician visits. The work group felt that the intervention is or probably is acceptable to key stakeholders with more confidence and acceptability for PICO 1.
For the resource use domain, Q -P-B was cost -saving relative to the current recommendation
(vs. Q -Q-B- B). P-P-N could improve health outcomes but costs $11.3 million per QALY saved
(vs. Q -Q-N). Q-P-P is cost -saving compared to Q -Q-B-B. Q -P-P is $4.5 million per QALY saved
more than Q -P-B. The work group felt PICO 1 would efficiently allocate resources, but this
varied for PICO 2 and 3.
56

 For equity, an increase in IMD has been observed among Black or African American individuals.
Among 11- to 20-year -olds, case counts were too small to examine by year, but the average
annual incidence across 2015-2023 was highest among Black or African American individuals. IMD data by ethnicity showed a higher incidence among Hispanics starting in 2019. Among 1 1-
to 20-year -olds , the average yearly IMD rate was higher among those who were not Hispanic or
Latino. Counties with lower socioeconomic status (SES) had fewer MenB doses stocked
compared to higher SES counties . The provider ’s or patient's awareness of an SCDM
recommendation is a prerequisite for patient discussions and could lead to health inequities.
The pentavalent vaccine could potentially reduce disparities among those interested in MenB
vaccination but not receive clinical care, including a discussion of the MenB vaccine. The lack of MenB vaccine interchangeability currently restricts existing MenABCWY vaccine use to patients and providers stocking Pfizer MenB vaccine products. The work group felt that health equity would probably be increased or be increased with the GSK pentavalent vaccine. This is different
from responses previously noted for the Pfizer vaccine.
Dr. Schillie shared that challenges with insurance or financial burdens related to the pentavalent
vaccine are not expected for the feasibility domain. GSK pentavalent vaccine would provide an additional option and may reduce the number of doses for some people. The lack of MenB
vaccine interchangeability complicates stocking considerations. Overall, the work group felt the
intervention would be feasible to implement.
In summary, the determinations are generally favorable for PICO 1 and somewhat less
favorable for PICO 2 and 3. For PICO 1, the work g roup felt that the desirable consequences
outweighed the undesirable ones . For PICO 2 and 3, the work group was divided. They did feel
that there was sufficient information to move forward with the recommendation. The work group
does recommend the intervention for PICO 1. It does not recommend the intervention for PICO 2 and was evenly divided in recommending PICO 3. Several Work Group members noted that it
would be important to harmonize recommendations between the GSK and Pfizer pentavalent
vaccines unless there is a vaccine-specific reason for having a different recommendation. An
interim recommendation for the GSK vaccine could mirror the recommendation made for the
Pfizer vaccine last year. Recommendations for use of both pentavalent vaccines could then be revisited as part of future adolescent schedule deliberations .
Dr. Loehr invited the ACIP members' comments on PICO 3 since the work group differed in opinion on that option but may favor it. He stated that accepting this would cause a lack of
harmony between the two pentavalent vaccines. He does not feel it is acceptable because it
would not be harmonized among the vaccines.
Dr. Chu agreed that harmonizing is essential. She felt the most logical thing would be to accept
PICO 1 and then wait for subsequent data showing whether the P -P strategy is comparable to a
three-dose strategy.
Dr. Shaw requested confirmation that the P-P-B vs the current recommendation has not been
modeled.
Dr. Schillie stated that the work group is considering revisions to the adolescent schedule in the
coming months but would first like to address the use of the GSK pentavalent vaccine.
Currently, the work group only considers the pentavalent vaccine in the context of different options for existing recommendations.
57

 Dr. Asturias emphasized that before integrating any pentavalent vaccine into the immunization
schedule, we should transition from using a combination of vaccines with both a recommended
schedule and a shared clinical decision-making schedule to including the MenB vaccine as part
of the recommended schedule. I f MenB is to be added, it should be fully endorsed as a
recommendation rather than leaving it as a shared decision option, which could create confusion among parents and providers. This approach raises the question of whether we should prefer a three-dose series or maintain a two-dose regimen. Dr. Asturias expressed his concern about any changes that might diminish the first recommendation, which he noted that
parents have consistently valued.
Dr. Loehr clarified that the Q -P-B schedule (PICO 1), which the work group is considering
recommending, is still a shared clinical decision-making. The P and B are only offered if, after
shared clinical decision- making, the family or the child decides that they want B.
Dr. Maldonado, as a pediatrician, expressed concerns regarding the complexities of shared clinical decision-making, particularly for primary care providers dealing with devastating diseases with low incidence rates. She highlighted the challenges faced by providers in addressing this issue, especially considering the notably low uptake of the MenB vaccine
attributed to shared clinical decision- making. Dr. Maldonado suggested the importance of
streamlining recommendations to align them with the routine vacci nation schedule, advocating
for a swift transition into a non-shared clinical decision-making approach to enhance vaccination
uptake and ensure patients receive timely and effective care.
Ms. Moser clarified that the Pfizer vaccine is already approved for what we show at PICO 1. The
impending schedule review made this discussion very complex for the work group. It was
determined that it was best to address the GSK vaccine in comparison to the Pfizer vaccine .
The work group will revisit this when we return to looking at the routine schedule.
Dr. Brooks addressed Dr. Loehr's point regarding the importance of focusing on ICERs that
amount to millions of dollars. He noted that issues would likely arise if we do not achieve
harmonization, and therefore, he would not support going out of harmony. He expressed his preference for PICO 1. If the family wishes to pursue option B, it would be a cost-saving choice. Seeing the absolute numbers in some of the outcome data would be beneficial since they are
very, very low.
Dr. Ch en agreed with the need to harmonize to reduce complexity. She also requested
confirmation that the two pentavalent vaccines are not interchangeable because they contain different MenB components. If so, it would be difficult for clinics to stock all three vaccines. She raised the issue of the duration of immunity for MenACWY.
Dr. Schillie confirmed that Dr. Che n’s assumption was correct.
Dr. Talbot noted that while the QPB may appear simple, the reality is more complex. When
stocking three vaccines with "Meningitis " on their labels, there is a significant risk of
administering the wrong vaccine. This is an important consideration. She pointed out that when the conjugate pneumococcal vaccine was introduced, there were frequent errors in vaccine
administration. Dr. Talbot appreciates the debate surrounding the appropriateness of ICERs.
She is open to accepting higher ICERs, suggesting that other areas in medicine may be more suitable for cost savings. Additionally, she emphasized the importance of the working group returning to find a simplified standard vaccine that does not rely on shared clinical decision-making, as it has proven ineffective.
58

 Dr. Schechter inquired whether there w ere enough data to do a sensitivity analysis on the
potential protection of gonococcal disease in young adults.
Dr. Schillie responded that the vaccine is anticipated to be licensed to prevent meningococcal
disease; however, it is known that these vaccines have about 30-40% efficacy against gonorrhea infections. This, however, was not factored into the cost-effectiv eness analysis, but
theoretically, this will make it more cost-effective when considering the benefits of gonorrhea prevention.
Dr. Sarah Schillie (CDC/NCIRD) introduced the MenB -4C ( BEXSERO) interval and dosing label
change. T
…[truncated]

Summary: MEETING OF THE ADVISORY  COMMITTEE ON IMMUNIZATION  PRACTICES (ACIP)  OCTOBER 23-24 , 202 4  MEETING SUMMARY  Trade names are used for identification purposes only and do not indicate endorsement.                                                                                WEDNESDAY : OCTOBER 23, 2024  WELCOME AND INTRODUCTIONS  Call to Order/Roll Call  Dr. Melinda Wharton (ACIP Executive Secretary) called the October 23, 2024, Advisory …