summary 2023 04 19 508

MEETING OF THE ADVISORY
COMMITTEE ON IMMUNIZATION
PRACTICES (ACIP)

APRIL 19 , 2023
MEETING SUMMARY

CONTENTS
WEDNESDAY: APRIL 19, 2023 .................................................................................................................... 2
WELCOME AND INTRODUCTIONS  ...................................................................................... 2
Call to Order/Roll Call ......................................................................................................... 2
Announcements  .................................................................................................................. 2
COVID -19 VACCINES  ............................................................................................................ 4
Session Introduction ........................................................................................................... 4
COVID -19 Vaccine Program Updates  ................................................................................. 4
mRNA COVID -19 Bivalent Booster Vaccine Safety Update  ................................................ 7
v-safesm After Vaccination Health Checker  .........................................................................12
COVID -19 Vaccine Effectiveness Updates  .........................................................................14
Updates to COVID -19 Vaccine Policy: Considerations for Future Planning ........................19
Updates to Interim Clinical Considerations for Use of COVID -19 Vaccines  ........................23
PUBLIC COMMENT  ..............................................................................................................29
Overview  ............................................................................................................................29
Public Comments  ...............................................................................................................29
CERTIFICATION  ......................................................................................................................................... 33
ACIP MEMBERSHIP ROSTER  .................................................................................................................. 34
ACRONYMS USED IN THIS DOCUMENT  ................................................................................................. 42

2

WEDNESDAY : APRIL 19, 2023

WELCOME AND I NTRODUCTIONS

Call to Order/Roll Call

Dr. Grace Lee (ACIP Chair) called to order and presided over the April 19, 2023 Advisory
Committee on Immunization Practices  (ACIP ) meeting.  Dr. Lee co nducted 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
conflict s of interest (COIs) were  identified.  The following potential COI was identified:


 Dr. Camile Kotton is involved in a clinical trial for Takeda for an investigational antiviral that does not involve any work with vaccines.

Announcements

Dr. Melinda Wharton (ACIP Executive Secretary, CDC)  noted  that copies of the slides for the
meeting were available on the ACIP website and were made available through a ShareLink ™
file for voting ACIP Voting, E x Officios , and Liaisons  Members . The ACIP  is, at its heart, a public
body. Engagement with the public and transparency in all of its processes are vital to the committee’s work. She indicated that there would be 1 oral public comment session during this
meeting, which was scheduled for 1:30 PM Eastern Time ( ET). To create a fair and more
efficient process, individuals interested in making an oral comment were asked to submit a request online in advance of the meeting. Priority is given to these advance requests.  If more
people make requests than can be accommodated, a blind lottery is conducted to determine who the speakers will be. Speakers selected in the lottery for this meeting were notified in advance of the meeting. Members of the public also may submit written comments via
https://www.regulations.gov  us
ing Docket Number  ID CDC- 2023-0 028. Information on the
written public comment process, including information on how to make a comment,  can be
found on the ACIP website.

A
s noted in the ACIP Policies and Procedures manual, ACIP members agree to forgo
participation in certain activities related to vaccines during their tenure on the committee. For certain other interests that potentially enhance a member’s expertise  while serving on the
committee , CDC may issue limited COI waivers. Members who conduct vaccine clinical trials or
serve on  data safety monitoring board s (DSMB s) may present to the committee on matters
related to those vaccines, but those m embers are prohibited from participating in committee
votes  on issues related to those vaccines. Regarding other vaccines of the concerned company,
a member may participate in discussions with the provision that he/she abstains on all votes
related to that  company. ACIP members state  any COIs  at the beginning of each meeting.
 Dr. Wharton reported that Since the COVID -19 vaccination program began in the United States
(US) in December, 2020,  more than 670 million doses of COVID- 19 vaccines have been
administered  to 270 million people. A lot has happened since the original authorizations of
COVID -19 vaccines.  There have  been multiple changes to recommendations for vaccine use as
additional vaccines became available and vaccines were authorized for additional age groups.
During the February 2023 ACIP meeting,  there was discussion of future directions for the
COVID -19 vaccination program.  This proposal included moving toward a single dose of an
3
 updated vaccine for most people,  and additional doses needed  only for young children who may
not yet have been exposed to COVID , older  adults, and immunocompromised people. With  the
previous day’s regulatory action by the Food and Drug Administration  (FDA) , a large step was
taken in this direction. She invited colle agues from the FDA to provide an update on  that action.

Peter Marks M., PhD (CBER/FDA)  indicated that FDA’s ultimate objective is to improve public
health by facilitating better updated COVID -19 vaccine coverage  and those eligible for
vaccination. The previous day’s action was an initial effort , based  on the totality of evidence
available,  to simplify the vaccination regimen for most individuals  and authorize the current
bivalent vaccines to be used for all doses administered to individuals 6 months of age  and older,
including an additional dose or doses for certain populations.  Most  individuals, depending on
age previously vaccinated with an original or monovalent COVID -19 vaccine,  who have not
yet received the do se of a bivalent vaccine, may receive a single dose of a bivalent vaccine.
Most unvaccinated individuals may receive a single dose of a bivalent vaccine rather than
multiple doses  of the original monovalent mRNA vaccines in order to be considered protected.
Most individuals who have already received a single dose of the bivalent vaccine are not
currently eligible  for another dose with some exceptions. The FDA intends to make decisions
about future vaccination for all of the various populations after receiving recommendations on
the strain composition at an FDA Vaccines and Related Biological Products Advisory Committee
(VRBPAC) m eeting to be held in June  2023,  at which time strain selection will be discussed
for the coming year or season.  As noted, individuals 65 years of age  and older who have
received a single dose of a bivalent vaccine may receive one additional dose of vaccine at least
4 months following their initial bivalent dose. M ost individuals with certain kinds  of
immunocompromise who have received a bivalent COVID -19 vaccine may receive a single
additional dose of a bivalent COVID -19 vaccine at least 2 m onths following a dose of that
vaccine.  Additional doses may be administered at the discretion of and intervals determined by
their healthc are provider  (HCP). The one exception is for immunocompromised individuals 6
months through 4  years of age  for whom the eligibility  for additional doses will depend upon the
vaccine previously given to the individual.  Children 6 months through 5 years of a ge who are
unvaccinated may receive a 2 -dose series of the Moderna bivalent vaccine.  Children 6 months
through 4 years of age may receive a 3 -dose series  of the Pfizer -BioNTech bivalent vaccine.
Children 5 years of age may receive either 2  doses  of the Moderna bivalent vaccine or a single
dose of the Pfizer -BioNTech bivalent vaccine.  Children 6 months through 5 years of age who
have received 1 , 2, or 3 doses  of a monovalent COVID -19 vaccine may receive a bivalent
vaccine, which is essentially to complete  that initial vaccination series. FDA realize s that this
updated regimen is still  somewhat more complicated than desirable but view s it as an interim
step moving into the next cycle of strain selection, which is coming up in late Spring to early
Summer.  FDA will f urther consolidate and simplify the regimen as  labeling is further updated  for
these vaccines.  Ultimately, the goal is to have the regimen simple enough for patients to easily
understand  and providers to easily administer. For now, the key message is that for older
children and adults up to age 65,  a single bivalent vaccine is appropriate for prevention of
COVID -19 under the current Emergency Use Authorization (EUA) . In terms of those who have
received non -mRNA vaccines, FDA will be discussing with manufacturers how to further update
those vaccines  so that there will be options available moving forward. The previous day’s action
does not affect those vaccines at this time.

Dr. Grace Lee (ACIP Chair)  thanked FDA colleagues for their continued attention to addressing
the COVID -19 pandemic, recognized that this is an evolution of recommendations or
authorizations over time, and expressed appreciation for FDA’s attempt to a more simplified
future state.

4

COVID -19 VACCINES

Session Introduction

Dr. Matthew F. Daley (ACIP WG Chair)  introduced this session on behalf  of the ACIP COVID -
19 Vaccines Work Group  (WG) . As they just heard from Dr. Marks,  there were FDA
authorizations on April 18, 2023  that includ ed updating the COVID -19 Vaccine EU A, including
the use of bivalent mRNA vaccines  for all doses and indications administered to individuals
ages 6 months and older  and additional doses for certain specific populations.1
 Since the February 2023 ACIP meeti ng, the COVID -19 Vaccines WG  reviewed a number of
data points around pediatric COVID -19 vaccination.  They also reviewed the epidemiology of
COVID -19, including among adults ≥65 years of age. The WG heard a number of vaccine
effectiveness  (VE) updates . In a ddition, they reviewed preliminary results  from pediatric cost -
effectiveness analyses  and discussed additional doses in vulnerable populations.  The February
24, 2023 ACIP meeting  included COVID -19 updates and discussions on vaccine safety , VE,
and epidemiology and hospitalization data. In addition, there were presentations and discussions on a benefit -risk analysis, c onsiderations for transition to a bivalent primary series ,
and future directions of COVID -19 vaccines, including updates to vaccine policy .

The session on April 19 included vaccine safety updates , VE data updates, presentations on
epidemiology and hospitalization data and a benefit -risk analysis, c onsiderations for transition to
bivalent primary series , and discussion on f uture directions of COVID -19 vaccines —including
updates to vaccine policy .

COVID -19 Vaccine Program Updates

Georgina Peacock, MD, MPH, FAAP (CDC/NCIRD) presented COVID -19 Vaccine Program
updates. As  a reminder, she reviewed the key objectives that were set forward at the beginning
of the pandemic , which were to: 1) ensure safety  and effectiveness ; 2) reduce mortality,
morbidity,  and the incidence of COVID -19 disease; 3) h elp minimize disruption to society and
the economy,  including maintaining healthcare capacity; and 4) ensur e equity in vaccine
allocation and distribution.
Moving into the next phase, it is important to keep these objectives in mind  for the US COVID -
19 Vaccination Program . In terms of the reasons for changes in the program, the Public Health
Emergency (PHE) will end on May 11, 2023. Regarding what will change, it is possible that there will be reduced submission of vaccine administration data from some jurisdictions  on a
national level . This is going to limit the completeness  of the administration data that can be
reported report on a national level. CDC has  been working with jurisdictions  to sign an extension
of their COVID -19 Data Use Agreement s (DUAs)  that will extend CDC’s ability to get data f rom
most states until the end of 2023. It is expected  that that a few jurisdictions  may not submit
those data based on state laws and other issues that are impacted by the end of the PHE .
Nevertheless, CDC still will be getting the majority of administration data on COVID -19
vaccines. Other things will not change. CDC will continue to work  with public and private
partners to learn more about the short - and long- term health effects associated with COVID -19
in terms of who is affecte d and why and to implement vaccine recommendations  to optimize

1 https://www.fda.gov/news- events/press -announcements/coronavirus- covid -19-update- fda-authorizes -changes -simplify -use-
bivalent -mrna -covid -19-vaccines
5
 protection. FDA’s EUAs will remain in place for COVID -19 products, including vaccines,  even
beyond the PHE . All vaccines purchased by the US Government  (USG) will continue to be
distributed and available for free. CDC is committed to ensuring a strong immunization program
going forward as changes continue to occur.
 Commercialization  of COVID -19 vaccines is expect ed to occur in early Fall 2023.
Commercia lization is the transition of vaccines  previously purchased by the US G to established
pathways  of procurement, distribution,  and payment for vaccinations  by public and private
payers.
2 Considerations include what will be authorized by FDA and recommended by CDC,
and the alignment with any  strain changes due to potential variants. After commercialization ,
vaccines will remain free for most people through the Vaccines for Children Program  (VFC), the
Children ’s Health Insurance Program  (CHIP) , most commercial  insurance, and Medicare  and
Medicaid programs .

A focus on vaccination equity has been a very important part of the COVID -19 Program.  CDC
has been working with national, state, tribal, and territorial health departments; healthcare; and
community partners to ensure that all people have fair  and just access to vaccination. This  effort
also has addressed many issues related  to vaccine confidence. Given that access and
confidence go hand- in-hand, there has been a major emphasis on these over the past couple of
years. CDC uses a S ocial Vulnerability Index  (SVI)3 to support areas that are at increased risk.
The SVI allows health departments  and others to look at  vaccine coverage at  the sub -county
and C ensus track levels to determine where there is  social vulnerability  in order to target efforts
to increase vaccine coverage. Making sure that uninsured adults have continued access to
COVID -19 vaccines with as few financial barriers as possible is a top priority.
 An important announcement was made by the HHS Secretary  in the last few days that t here will
be an “HHS Bridge Access Program For COVID -19 Vaccines and Treatments ” for uninsured
adults.
4 This program is being put in place  to serve th e 30 million uninsured adults in the US.
This supports the existing public sector vaccine safety net.  Traditionally, CDC has  worked with
state  and local health department partners to make vaccines available through the 317 Program
that provides vaccines and supportive infrastructure to vaccinate uninsured adults.  Funding for
this effort will be made available through this existing program.  Funding  also will be going to
Federally Qualified Health Centers  (FQHCs) . In addition, there will be a funded partnership with
pharmacy chains. This will allow another way for uninsured adults  to be able to receive vaccines
free of charge.  A major development  over the last couple years and throughout the pandemic is
that pharmacies have been a key partner in helping to increase access to COVID vaccine.
Pharmacy partners  administered COVID vaccine during the pandemic, which is an important
model in terms of consideration of the domestic vaccine program.  CDC is committed  to thinking
through and supporting pharmacy networks in terms of moving forwa rd in this new phase of the
COVID vaccine program.  One of the ways to do this is through the Bridge Program for the
uninsured.

2 https://aspr.hhs.gov/COVID -19/Pages/FAQ -Commercialization.aspx
3 https://www.atsdr.cdc.gov/placeandhealth/svi/at -a-glance_svi.html
4 https://www.hhs.g ov/about/news/2023/04/18/fact -sheet -hhs-announces -hhs-bridge- access -program -covid -19-vaccines -treatments -
maintain- access -covid -19-care-uninsured.html
6
 Another issue that has arisen that affects the COVID -19 Vaccine Program is the  Public
Readiness and Emergency Preparedness  Act (PREP Act ) for Medical Countermeasures against
COVID -19.5 HHS  recently announced an intention to amend the declaration under the PREP
Act for Medical Countermeasures against COVID -19. By issuing this amendment,  the HHS
Secretary intends to extend immunity  liability to pharmacists, pharmacy interns, and pharmacy
technicians to administer COVID -19 and seasonal influenza vaccines through December 2024.
This amendment will allow for the ability of pharmacists to vaccinate children for routine
vaccinations down to 3 years of  age.
 Another important development is the Inflation Reduction Act,
6 which includes some key
provisions that eliminated cost -sharing for all ACIP -recommended vaccinations under Medicaid
and Medicare Part D or equivalent plans.  This started on January 1, 2023 and is  continuing to
be implemented. While not yet fully in place, it guarantees  that nearly 50 million Medicare
beneficiaries and more than 80 million Medicaid beneficiaries will have access  to all ACIP -
recommended vaccinations for adul ts without any cost -sharing.  This is a very important
development for the coverage of vaccines across the lifespan.

Despite these advances, a comprehensive Vaccines for Adult s (VFA) Program  is still needed
that will fill in th e gaps in places  where no coverage  is currently available.  The proposed VFA
would reduce the spread of vaccine- preventable diseases and pave the way for greater health
equity. In CDC’s FY24 President’s Budget Request, there is a request for the proposed VFA
Program. This $1.2 billi on request  for FY24 equates  to $12 billion over 10 years  that would be
utilized for vaccine purchase, program operations , provider administration, and provider fee
reimbursement . This would cover all ACIP -recommended vaccines  for uninsured adults, which
equates to approximately 30 million people in the US . In addition to this, not included in the VFA
proposal,  is the important provision for the support  of vaccine confidence and equity activities
need to continue  through the discretionary funding related to Section 317.

Discussion Points
 Dr. Duchin (IDSA) expressed concern about cessation of reporting of vaccine administration
data, given that it seems critical to ensuring equity in access and distribution.  He requested
information about how this gap would be addressed long- term and whether it is part of the new
informatics initiative the CDC is working on. He applauded the movement forward in terms of
the Adult Vaccination Program  after so many years of adv ocacy by the National Vaccine
Advisory Committee (NVAC) and others  and asked what specifically  would be provided to state
and local health departments that administer these vaccines and carry out many of the
relationships  with community providers.
 Dr. Pea cock emphasized that there  has not been complete cessation of reporting of
administration data.  There will be some decreases after this PHE, most of which is related to
state laws  that prohibit sharing these  data with the federal  government.  CDC is working  with its
state partners to determine whether there are ways to continue to receive vaccine
administration data related to COVID and routine vaccinations.  Putting an extension of the
DUAs  into place for COVID  and negotiation of r outine vaccination DU As should be helpful. For
COVID vaccine s, the CDC COVID- 19 Vaccination Program Provider Agreement  is still in place .
At the peak, over 120,000 providers  were providing COVID vaccine . The agreement includes a
provision that providers need to report administration data of COVID vaccine. While it is

5 https://www.hhs.gov/about/news/2023/04/14/factsheet -hhs-announces -amend- declaration- prep- act-medical -countermeasures -
against -covid19.html
6 https://www.cms.gov/newsroom/fact -sheets/inflation- reduction- act-lowers -health- care-costs -millions -americans
7
 probable that CDC will not have the full  picture of what is occurring nationally , state health
departments will still have these data within  their Immunization Information Systems (IISs) . It will
still be necessary to consider ways  to ensur e equity  moving forward . There will be challenges,
but CDC has supported many partners who have been working with community -based
organizations  (CBOs)  to examine access and  confidence issues.  This work is continuing to be
funded and move forward.  In relation to the Adult Program and support of state  and local health
departments, that work is critical. As a domestic program is implemented that serves people
across the lifespan, the infrastructure that has been built  to serve children over the last 30 years
through the VFC Program serves as  a basis for providing vaccines for adults  through a VFA
Program. Built into that is an increase in the infrastructure, which is essentially the jurisdiction
awardee that CDC funds . That is an important part of the VFA proposal.

Dr. Sanchez  requested clarification with  regard to  the amendment to the PREP Act  in terms of
children down to 3 years of age and how that applies  to vaccine provided to children and
pregnant women .
 Dr. Peacock clarified that the PREP Act allowed for a number of vaccinators  to vaccinate people
all down to 3 years of age . Typically, there are state laws that differ by state that designate  who
can be vaccinators.  The PREP Act extended the ability to vac cinate to pharmacists, pharmacy
techs, and  pharmacy interns for COVID- 19 vaccine,  influenza vaccine, and routine childhood
vaccination.  This has been ongoing throughout the pandemic.  The amendment to the PREP Act
allows certain provisions to continue. Cert ain provisions  allow influenza and COVID vaccination
to continue down to 3 years of age, so there is coverage across the nation for that.  That
provision was not extended for routine childhood immunization, which now revert back to state laws. She apologized for not having any details on pregnant women.
 Dr. Dale y expressed gratitude for the continuing advocacy for the VFA Program.  Although death
from COVID -19 is largely vaccine- preventable,  it seems completely unfair that the ability to
access that vaccine is related to whether someone has health  insurance.

Dr. Peacock stressed that the announcement of the B ridge Program  represented an important
step forward toward ensuring administrative of a vaccination program  that serves people across
the lifespan.

mRNA COVID -19 Bivalent Booster Vaccine Safety Update

Tom T. Shimabukuro, MD, MPH, MBA (CDC/NCEZID)  described current data on ischemic
stroke following mRNA COVID- 19 bivalent booster vaccination from the following systems:
  CDC’s Vaccine Safety Datalink (VSD) Rapid Cycle Analysis (RCA) signal assessment for
ischemic stroke after Pfizer -BioNTech COVID -19 mRNA bivalent booster dose vaccination
in the age group ≥65 years old

 Vaccine Adverse Event Reporting System (VAERS) data on ischemic stroke following
mRNA COVID -19 bivalent booster dose vaccination

As a reminder, the VSD is CDC’s  active , electronic health record (EHR) -based surveillance
system that was established in 1990 as a collaborative project between CDC and 9 integrated
healthcare organizations. These analyses included the 9 participating sites  that have data on a
total of about 12.5 million individuals.

8
 VSD RCA pre -specified outcomes were assessed during weekly sequential monitoring after
bivalent booster vaccination.  The risk of pre- specified outcomes in 1 to 21 days following
vaccination were compared with bivalent vaccinated individuals who were 22 to 42 days out
following the bivalent dose.  This is a vaccinated concurrent comparator method  that assesses
cases in vaccinated individuals  in the risk window of 1 to 21 days compared to cases in
vaccinated individuals  in the comparison interval at  22 to 42 days. All analyses were  adjusted
for age, sex, race and ethnicity,  VSD site , calendar time (days) , and seasonality  (time).  The
signaling threshold is a 1 -sided p-value <0.01 .

This table shows the pre -specified outcomes  that were  monitored in the COVID -19 Vaccine
RCA and the settings in which they were monitored:

In the COVID -19 booster vaccination monitoring,  the RCA detected a statistical signal for
ischemic stroke  after Pfizer -BioNTech bivalent booster vaccination in the age group 65 years
and older.  No other VSD RCA pre -specified surveillance outcomes have signaled in any age
group for either of the mRNA COVID -19 bivalent boosters or when data for the 2 mRNA  vaccine
types were combined or pooled.  VSD investigations  of an RC A signal to assess  whether it
reflects a real effect of vaccination on an outcome include several steps,  including the following:

 Data quality assessment for errors, anomalies, or missing or late- arriving data
 Analyses using different comparators than the primary concurrence  (e.g., un-boosted,
unvaccinated, or “ historical ” comparators ) to supplement the primary analyses
 Additional investigations to provide context , such as background rates
 Graphic displays of outcome incidents, day -by-day after vaccination , using temporal scan
statistics  to assess apparent clustering to examine the temporal clustering of outcome
events in subgroups defined by demographics, site, or simultaneous exposure (e.g., influenza vaccine)
 Further analyses by site or subgroup conducted as appropriate if the signal is driven by a
strong association  in one subgroup or VSD site
 Chart review to confirm cases and collect additional data,  such as date of s ymptom onset
 Consideration of epidemiologic studies to further investigate surveillance findings

9
 Moving now to the results of the VSD COVID -19 RCA analyses of ischemic stroke after Pfizer -
BioNTech bivalent booster among people ≥65 years of age,  substantially more Pfizer -BioNTech
(643,372)  booster vaccines were administered during the bivalent booster program compared to
Moderna  (355,767) between 8/28/22 and 4/8/23. There were substantially more doses
administered early in the booster program, with the peak of COVID -19 bivalent booster with
Pfizer -BioNTech at about the same time as  peak influenza vaccination in this age group.

This table reflects the VSD RCA ischemic stroke case definition, onset date, codes to detect
prevalence, and exclusion criteria:

 In terms of the  bivalent RCA concurrent comparator  analysis o f ischemic strokes during a 1-  to
21-day risk interval versus a 22 - to 24-day comparison interval , the primary analysis  was the
vaccinated concurrent comparator , shown for the most current weekly analysis  with d ata
through April 8, 2023.  This analysis was broken down by age groups 18─ 64 years and 65+
years . While younger age groups were assessed, ischemic stroke is a very rare outcome  and
those data are not informative for this analysis. For the most recent sequential analysis by the 2
age groups and by vac cine (Pfizer, Moderna)  none of the  findings met the signaling threshold,
which is a p -value of <0.01. In the nominal analysis,  all the 95% confidence intervals included
1.0, so it also was not statistically significant. As Dr. Shimabukuro recalled, the last time he
showed these data, the nominal analysis for Pfizer vaccine among persons ≥65  years of age the
was statistically significant  and the sequential analysis did not hit the signaling threshold.
 In the weekly analys es ischemic stroke after Pfizer -BioNTech bivalent booster  for persons  age
≥65 years  from October 16, 2022  through April 8, 2023, the rate ratio  was 1.26 with a 95%
confidence interval of 0.99 to 1.60  as of April 2, 2023.  A statistical signal for ischemic s troke
following the Pfizer -BioNTech bivalent booster  in this age group was first detected in November
2022.  This signal persisted through January 2023 , but did not meet the signaling threshold for
the last 10 weekly analyses.  An important caveat is that in  the VSD RCA, once there is a signal,
there always is a signal.  While the most recent 10 weekly analys es did not meet the statistical
threshold for a signal, there still was a signal  for this outcome. However, CDC continues to
follow these weekly analyses over time because  they think it is informative  to do so.

10
 In addition to the primary analysis,  supplemental analyses  also are performed. The
supplemental RCA analyses  assessing ischemic strokes in the 1 - to 21 -day risk interval
comparing bivalent boosted to unboosted concurrent comparators  can be thought of as a
vaccinated versus unvaccinated comparison . A note for this particular analysis  is that it is not
truly a vaccinated versus unvaccinated : it is a bivalent booste d versus unboosted, but eligible
for a booster.  These individuals probably  are more similar than true vaccinated versus
unvaccinated.  In the supplemental analyses, the adjusted rate ratio was  1.01 (0.86─1.19) and
was not statistically significant.

As ment ioned earlier, much of the vaccination with the Pfizer -BioNTech bivalent booster was
occurring at the same time as peak influenza vaccination in the VSD  in persons  ≥65 years  of
age. A  substantial number of the cases  in the risk window also had simultaneous  influenza
vaccination.  Most of the individuals ≥65 years  of age who had simultaneous  influenza
vaccination received a high- dose or  adjuvanted influenza vaccine,  which might be expected
because those vaccines are preferential ly recommended.  A stratified analysis was conducted  to
assess ischemic stroke incidence during the risk window compared to the comparison window
among persons ≥65 years of age, with and without simultaneous  influenza vaccination. For
individuals who received the bivalent Pfizer -BioNTech booster and simultaneous high- dose or
adjuvanted influenza vaccine, the adjusted rate ratio was elevated but not statistically significant
at 1.59 (0.99─ 2.61). The bivalent Pfizer -BioNTech bivalent booster without any same day
influenza vaccine  had an adjusted rate ratio of 1.01 in February 2023 in the simultaneous group
and was statistically significantly elevated.  It is now attenuated and is no longer statistically
significant.

To summarize, the statistical signal persisted during the  November to January timeframe. The
rate ratio has slowly attenuated from 1.92 to 1.26  and has not met signaling criteria during the
past 10 weekly analyses. Supplemental analyses using an unboosted concurrent comparator
showed a rate ratio of 1.01, which was  not st atistically significant.  Analyses evaluating
simultaneous high -dose or adjuvanted  influenza  vaccine showed a rate ratio of 1.59,  which also
was not statistically significant. Separate analyses did not detect an elevated rate ratio for stroke
after influenz a vaccine alone. In previous presentations,  data from some  supplemental analyses
suggest ed comparison interval rates were lower than expected.  There can be several reasons
an elevated rate ratio might be seen. There may be more than expected cases in the r isk
window  compared  to the comparison window , less cases than expected in the comparison
window compared to the risk window, or  a combination of two.  Data previously presented in
February suggest ed that  there was some evidence of a lower rate in the comparison interval
than would be expect ed.

Moving on to VAERS. As a reminder, VAERS is the national spontaneous reporting or passive
surveillance system  that is co-managed by CDC and FDA.  This system is good at rapidly
detecting safety signals  and rare adverse events  (AEs) . As a spontaneous reporting system, its
main limitation is that causality cannot be assessed based on VAERS data alone.  In general
summary of US reports to VAERS following bivalent booster COVID -19 mRNA  vaccination
among people ≥5 years  as of April 2, 2023 (N=28,363) , the distribution by age, sex,  and serious
status was similar regardless of manufacturer. For both Pfizer -BioNTech and Moderna
vaccines, 93% of reports were non -serious . That is consistent  with what  has been observed with
other monovalent booster vaccinations.

In terms of r eports to VAERS of ischemic stroke or transient ischemic attack (TIA) after  bivalent
COVID -19 mRNA vaccination in people ≥18 years  of age after bivalent vaccination as of April 2,
2023, there were 252 preliminary reports of ischemic stroke or TIA.  Of these, 34  are still under
11
 review , 9 were excluded based on chart review , and 60 were non- ischemic strokes verified by
chart review. That left a total of 149 verified reports of ischemic s troke or TIA comprised of 110
ischemic strokes, 35 TIAs, and 4  ischemic stroke + TIA. There are 112 Pfizer BioNTech bivalent
cases and 37 Moderna  bivalent  cases.  The m edian age was 72 years, median time to onset
was 13 days, 68 were in males and 81 were in females.  All 149 verified reports had at least 1
risk factor for ischemic stroke, with the most common being hypertension.  Some of these cases
received simultaneous  influenza vaccination. In those 18─64 years of age, 6 had simultaneous
administrati on with standard dose influenza vaccine . Among those ≥65 years  of age, 1 had
high- dose, 3 had adjuvanted, 2 had standard dose, and 1 had an unknown type of influenza
vaccine. This table show s VAERS reports and reporting rates of ischemic stroke and TIA in the
3 weeks  after bivalent vaccination people 18─ 39, 40─ 64, and ≥65 years  of age:

This is limited to reports with onset within the  3 weeks , so the observed reports are the verified
VAERS reports in these specific age and vaccine strata.  The chart verified reports plus reports
under review  is essentially a sensitivity analysis  in which the reports under review are  assumed
to be  true reports.  The easiest way to explain this ,  focus ing on the bottom row, this is saying
that within in a hypothetical cohort  of individuals ≥65 years  of age ( 9.6 million individuals ) about
3,500 stroke or TIA cases would be expected in a 3 -week  period.  The background rates are
based on the references at the bottom of the table. These are t hese observed versus  expected
cases, which  require s some assumptions.  While this is not a perfect analysis, it does provide
some perspective on what is being observ ed compared to what would be expect ed based on
background.  To provide some information on stroke in general from  CDC statistics, about every
40 seconds someone in the US has a stroke and about every 3.5 minutes somebody dies from
a stroke.  About 87% of strokes are ischemic strokes.  In this analysis,  no unusual or unexpected
reporting patterns were observed and no ev idence of a safety concern  was detected for
ischemic stroke  with either mRNA COVID- 19 bivalent booster in VAERS monitoring.

In terms of COVID -19 mRNA bivalent booster vaccination safety  data from other monitoring
systems and programs,7 FDA monitoring in the Center for Medicare and Medicaid Services
(CMS ) data and Department  of Veterans Affairs  (DVA)  monitoring in the Veterans Affairs ( VA)
system have not detected any safety signals  using historical comparator designs. Surveillance
conducted by i nternational regulatory  and public health partners have not detected a safety
concern for ischemic stroke.  There is no evidence of a safety signal for ischemic stroke in

7 Note: These surveillance activities did not include analyses to evaluate the effect of simultaneous flu vaccination; different
formulations of COVID -19 mRNA bivalent booster vaccinations were used globally .

12
 Pfizer ’s global monitoring of COVID boosters . No safety signals were dete cted for ischemic
stroke for primary series or monovalent boosters for Pfizer -BioNTech or Moderna vaccines in
US and global monitoring.

In terms of further evaluation, CDC will continue to consult with other surveillance systems to
better understand the possible role  of simultaneous high- dose or adjuvanted influenza
vaccination with COVID -19 vaccination, as well as the possible decreased rate of stroke
observed in the VSD in the 3 to 6 weeks following vaccination. CDC is in the process of chart
reviewing a random sample of 100 cases across VSD sites and will continue to monitor VAERS.
CDC continues to recommend that everyone eligible for a COVID -19 mRNA bivalent booster or
influenza vaccine get vaccinated.  CDC and FDA are engaged in epidemiologic analyses
regarding simultaneous vaccination with COVID -19 mRNA bivalent booster  and influenza
vaccines.
v-safesm After Vaccination Health Checker

Tom T. Shimabukuro, MD, MPH, MBA (CDC/NCEZID)  next presented an update on the v-
safesm after vaccination health checker , including a brief overview of v- safesm, contributions of v-
safesm to the COVID -19 response, data on historical and current participation in v- safesm,
planning for the wind- down of the current system  and the development of the next version of  v-
safesm, and continued safety monitoring of COVID -19 vaccines.  As a reminder, v -safesm was
implemented in December 2020 . It was designed to collect near real- time data by direct
outreach to vaccine recipients.  It was initially conceived to rapidly collec t basic safety data  (e.g.,
primarily local and systemic reactogenic and health impacts ) at the onset  of the COVID -19
vaccination program to provide early data while other systems like VAERS and the VSD were
accruing data.  In addition, v -safesm identified vaccinated pregnant persons for possible
enrollment in the COVID -19 Vaccine Pregnancy Registry.  It also was u seful in rapidly collecting
early safety data when authorizations and recommendations expanded to other age  and risk
groups. It was quickly adapted to capture simultaneous administration  of other non- COVID
vaccines  (e.g., influenza vaccine) . It was designed, built, and supported in collaboration with
Oracle Health Services under a donation agreement with  the Department of Health and Human
Services (HHS ).
 Enrollment  in v-safe
sm is by self -registration on a smartphone, with any dependents added  to a
guardian’ s account. Survey completion was prompted by text message reminders  for “health
check -ins,” which had links to online surveys. Call follow -up was performed on all participants
who reported a medically attended event. There was robust participation in its first year,  with 9.3
million participants and 131 million health surveys completed.  Total participation to date has
included 10.1 million participants and 151 million health surveys completed.  Most of the
registration and most  of the health surveys occurred in the first year.  v-safesm has been
particularly effective  in characterizing the basic safety of COVID -19 vaccines during early
vaccine i ntroduction and following new authorizations and recommendations. v- safesm has
successfully accomplished his mission  and worked as intended. This graph shows participation
in v-safesm over time :

13

Generally, registra tions  paralleled doses administered. As noted earlier, most new v -safesm
registrations and survey  completions occurred in the first year  of the vaccination program.  Use
has waned rapidly and has pretty low uptake at this point. Also noteworthy is that active
registra tion and  doses administering paralleled early on when many doses  were  administered.
Then there were peaks in doses administered largely represent ing new authorizations
and recommendations. However, there was not a corresponding surge in v -safesm uptake with
these new registrations. There probably were a lot of early adopters early  in the program, which
is not totally unexpected.
 It is important to understand what v -safe
sm is and is not. v -safesm was designed to rapidly
monitor  and assess common outco mes (e.g., local and systemic reactogenicity and health
impacts )—the basic safety profile of the vaccine. It is not designed to be a signal detection or
signal assessment system. Those systems  are primarily VAERS , VSD, FDA's Biologics
Effectiveness and Safety (BEST) System, and FDA , CMS,  and VA  active surveillance systems.

In terms of the next step for v- safesm, the timing for the final registration and completing of
surveys will be announced soon.  Follow -up will continue on reports of medically attended health
events. The next generation v- safesm is under development.  CDC plans to collect data on new
vaccines. Once developed and implemented,  the new  v-safesm will allow greater flexibility for
surveys and use  of CDC information technology (IT) infrastructure.  It will be designed to permit
longer -term support for collecting data rapidly from a large number  of vaccine recipients.  v-
safesm is one of the several compl ementary systems at CDC and one of many compl ementary
systems that the US G uses to monitor vaccine safety. CDC’s  standard established systems will
continue to monitor  and assess the safety of COVID -19 vaccines. That includes VAERS, the
VSD, and the Clinical Immunization Safety Assessment (CISA) Project.

Discussion Points
 Dr. Virginia Caine (NMA) observed that according to the VAERS data, Blacks have a 50%
greater stroke incidence than their White counterparts  and asked whether stroke incidence side
effects data were broken down by race and ethnic populations  to understand whether there
would be higher risk among Blacks over the age of 65 .

14
 Dr. Shimabukuro indicated that data on race and ethnicity are collected in V AERS, but because
VAERS is passive, the data on these variables is dependent upon the reporters  filling in that
information.  While the data are not analyzed by race and ethnicity, these data are collected .
This information is also collected in the VSD, but the ability to analyze at that level  is limited in
the VSD because of small numbers. He acknowledged the importance and said that
consideration can be given to exploring ways of getting better visibility  on race and ethnicity. At
least for the VSD RCA,  race and ethnicity  are not the primary variables in the RCA because the
finer the data are sliced , the greater the small numbers problem.

While he was glad the signal had not persisted and that there would be continuing
epidemiologic analyses regarding simultaneous  vaccine with the high- dose influenza and
COVID bivalent booster, Dr. Sanchez asked if any changes were anticipated in the
recommendation that they can be administered simultaneously or if there should be a cautionary note saying that there should be an interval of separation between the tw o.
 Dr. Shimabukuro said he did not think the data were sufficient to conclude that there is a safety
problem for ischemic stroke with the Pfizer vaccine in this age group,  or that there  is a safety
problem with simultaneous administration  of COVID and influenza vaccines. Additional w ork is
being done. FDA has a study in progress and CDC  and its VSD partners will continue to
evaluate the data.  At this time, the feeling is that the data are  not sufficient to conclude that
there is a safety problem  requiring make a change in recommendati ons.
 Dr. Lee  reflect ed on the importance of sustaining these vaccine safety surveillance efforts
beyond COVID -19. She reminded everyone that during H1N1, there was a similar effort in place
akin to v-safe
SM to monitor safety rapidly with the initial imple mentation of H1N1 vaccines, but it
was difficult to sustain.  With COVID -19, it was not clear how v -safeSM would be able to
contribute.  However, it has been quite impactful—especially for pregnant populations.  She
expressed gratitude to CDC for continuing t o sustain important and compl ementary safety
surveillance tool for the future.  It gave her confidence and she found it incredibly reassuring  that
based on the number  of compl ementary systems at CDC for vaccine safety and in partnership
with other federal agencies  (FDA, DoD, IHS, VA, and others ) that ACIP is are able to emphasize
the importance of vaccine safety to vaccination programs.

COVID -19 Vaccine Effectiveness Updates
 LCDR Ruth Link -Gelles, PhD, MPH  (USPHS/CDC)  presented  a summary  of vaccin e
effectiveness data available from CDC studies, including VE of the original monovalent vaccines
and updated bivalent vaccines.  This included presentations on  updated estimates  of VE of
monovalent vaccines for symptomatic infection in young children aged 6 months –4 years
(Pfizer -BioNTech) and 6 months –5 years (Moderna ), as well as an update on monovalent and
bivalent VE against severe disease in adults with  and without immunocompromising conditions.
For background,  she shared the national coverage estimates from CDC’ s COVID  Data Tracker
8
for the primary series among young children showing that young children have the lowest
coverage for either a single dose or a completed primary series , with just over 10% for 1 dose
and 6% for the complete primary series in children  2 to 4 years  of age . Coverage is even lower
among those under 2 years of age. Children vaccinated early may be meaningfully different
from those who remained unvaccinated, which may impact VE estimates.

8 https://covid.cdc.gov/covid -data- tracker/#vaccination -demographics -trends
15
 The Increasing Community Access to Testing (ICATT) platform includes community -based
testing data from pharmacies and partners nationwide.  It uses a test -negative design with self -
reported vaccine history at the time of test registration.  For th ese analys es, only children whose
caregivers reported symptoms and who were between the ages of  3 and 5 years for the
Moderna analyses and 3 and 4 years of age  for the Pfizer -BioNTech analyses were included.
Children whose caregivers reported that the child being tested had immunocompromising
conditions were excluded.  These data are for tests from July 4, 2022 through April 8, 2023,
although the analysis start date varied  depending upon the dose analyzed.  This was a period
when Omicron BA .4/BA.5 and XBB related sub- lineages predominated.

Looking at preliminary estimates of VE against symptomatic infection for monovalent Moderna
vaccine among children 3 to 5 years of age, VE was 40% (95% CI: 25 -52) for 1 dose  or a partial
series during the interval between the first and se cond doses.  VE for the complete 2 -dose
primary series of  Moderna was  47% (95% CI: 37 -54) over the entire  2 weeks to 6  months after
the dose.  Broken down by time since dose, VE decreased from 61% (95% CI: 47 -71) during the
first 2 weeks to 1 month  after the dose to 18%  (95% CI: -6-37), with confidence intervals
crossing the null during the 4 to 6 months after the dose.  Looking at the same information for
Pfizer -BioNTech in children 3 to 4 years  of age  for a 1 -dose partial  series,  VE was 20% with a
confidence interval that just crossed  the null  (95% ci: 0 -36). For 2 doses, which for Pfizer -
BioNTech also is a partial series, VE was 40%  (95% CI: 28 -50) in the interval between doses 2
and 3.  For 3 doses, a complete Pfizer -BioNTech primary series,  VE was 27%  (95% CI; 4- 45) in
the 2 weeks to 6 months  after the dose. There was not enough statistical power to break  down
the Pfizer - BioNTech complete series estimates by time since last dose.

There are a number of limitations for this analysis. As  noted earlier, vaccine coverage is low  in
children 5 years of age and under. When coverage is low, vaccinated children may be
meaningfully different than unvaccinated children , potentially biasing early VE estimates and
making the estimates less stable. The prevalence  of prior infection among children is high.
Based on CDC seroprevalence data through December 2022,  more than 92% of children  6
months through 17 years of age had a prior infection.  If unvaccinated children have protection
from prior infection, it may lead to an underestimation of VE.  However, the prevalence of prior
infection is so high that these estimates are likely  to represent the current situation among
young children in the US. While the goal of the US COVID -19 vaccination program is  to prevent
severe disease, the ICATT platform estimates VE for symptomatic infection only.  To date, l ow
vaccination coverage in this age group has p revented estimation of VE against more severe
disease. However, other VE platforms may impact future ability to estimate  VE in this group,
including against severe outcomes.  Given this context, VE against symptomatic infection can
provide important insight into vaccine protection.

In conclusion,  a complete monovalent primary series vaccination helped provide protection for
children 3 through 5 years of age against symptomatic SARS -CoV-2 infection for at least the
first 3 months after vaccination. Some waning of the monovalent Moderna primary series
appears  to occur by 4  to 6 months after the second dose. These patterns are similar to patterns
observed in older children and adults in the first months after vaccination. Waning of
monovalent Pfizer -BioNTech against symptomatic infection could not be assessed, but also is
likely based on analyses in older children and adults.  Children should stay up- to-date with
COVID -19 vaccines . CDC will continue to monitor VE in this age group,  including against severe
disease and for bivalent doses if possible.

16
 Moving to updated estimates of bivalent VE against ED and u rgent care (UC)  encounters  and
hospitalizations in adults 18 years of age and older , the VISION VE Network  is a multi- state
network based on EHRs. Like ICATT, it uses a test -negative design with cases having COVID -
like illness and a positive PCR  for SARS- CoV-2 and controls having COVID -like illness (CLI)
with a negative PCR. VE is adjusted for age, sex, race, ethnicity,  geographic region, calendar
time, and local rates of SARS -CoV-2 circulation.  Vaccination is determined via EHRs  and state
and city registries.  In terms of the absolute VE of monovalent and bivalent vaccines against  ED
and UC encounters among i mmunocompetent adults  among adults 18─ 64 years of age and
≥65 years of age, for those who received only monovalent doses, roughly a year has passed
since their last dose.  For those receiving bivalent doses, the time since last dose is  much
shorter.  For monovalent doses, there is little remaining protection.  For bivalent  vaccination, the
trends across the age groups are similar with bivalent VE at 53% (95% CI: 48 -58) for adults
18─64 years of age and 61% (95% CI: 57- 64) for adults ≥ 65 at 7 to 59 days after the first dose.
Estimated VE declines by 120 to 179 days  after the bivalent dose to 15% (95% CI: 2- 26) for the
younger group and 25%  (95% CI: 16- 34) for the o lder group.

For hospitalizations, there was s ome residual protection.  In contrast to the ED , effectiveness of
a monovalent dose was  21% (95% CI; 10- 30) for younger adults and 25% (95% CI: 18- 31) for
older adults.  For bivalent doses, trends were similar across age groups . However, there was not
enough statistical power  to interpret  estimates for 120 to 179 days out from the bivalent dose in
the younger group.  In older adults, there was waning at a higher point estimate than against
ED/UC encounters.  Regar ding absolute VE of bivalent booster doses  against hospitalization
among immunocompromised individuals ≥ 18 years of age, there was little remaining residual
protection of the monovalent vaccine.  VE estimates for bivalent vaccines start ed lower  than for
those of immunocompetent individuals at 30%  (95% CI: 12 -44), but the same patterns  of waning
have not been seen in this group thus far.

To provide a snapshot of who is being hospitalized with COVID -19 and the VISION VE Network ,
it is important to note that this analytic population does not match the population used in the VA
analysis precisely . It does give an overall sense of who is being hospitalized and who has
critical illness defined as “admission to intensive care or in- hospital death  within the VISION
Network.  The median age is approximately 75 years . Eighteen percent of those hospitalized and
24% of those with critical illness had an immunocompromising condition. This is compared to
roughly  3% in the overall US population.  Thirty percent of those in the hospital and 34% of those
with critical illness are entirely unvaccinated, which is particularly notable when considered along with the median age of this population and the fact that in the US as a whole, 94% of
those aged 65  and up have completed at least a primary series.  Also notable is t hat 17% of
those hospitalized and 15% of those with a critical hospitalization had received a bivalent
booster  compared to about 43% of the overall US population over 65 years of age.

The next update is on data published by CDC in December  2022 looking at the effectiveness  of
the bivalent boosters against hospitalization in adult s ≥65 years of age through the Investigating
Respiratory Viruses in the Acutely Ill ( IVY) Network , which is a multi- state VE platform  that uses
a prospective test -negative design. For this analysis, participants were  enrolled from 25
hospitals  in 20 states with hospitalization between September 8, 2022 and April 1, 2023. Note
that this analysis includes data beyond what was published in the MMWR  in December  2022 .
Participants are adults hospitalized with COVID -like illness. Cases have a SARS -CoV-2 positive
PCR or antigen test  and controls are negative for SARS -CoV-2 and influenza by PCR.  Models
are adj usted for age, sex, race, ethnicity, admission date, and HHS region.

17
 In terms of updated  IVY results among adults ≥65 years of age for  absolute VE against
hospitalization, comparing people with at least 2 monovalent doses but no bivalent dose to
unvaccinated people , VE was 13% with a confidence interval crossing the null  (95% CI: - 9-30).
This is  consistent  with the limited to no residual protection of the monovalent doses. Absolute
VE of a bivalent booster follow ed a similar pattern , with high initial pro tection and apparent
waning.  Looking at the r elative VE of a bivalent booster comparing individuals  who received a
bivalent booster to individuals with at least 2  monovalent doses but no bivalent booster , the
additional protection offered by a bivalent booster  was 60% (95% CI: 45- 71) with waning
apparent  with more time since the dose. Note that as with the VISION estimates , the median
time since last dose was  over a year  for monovalent only recipients.

Regarding the durability of monovalent VE protection against the most critical illness,  invasive
mechanical ventilation (IMV)  and death among adults ≥18 years of age in the IVY Network, this
analysis assessed VE of 2 to 4 monovalent mRNA vaccine doses against IMV  or death among
immunocompetent adults  ≥18 years of age through January 31, 2023.  Overall, this group is  at
approximately 8 months  since their last monovalent dose.  For the overall group, VE was  62%
(95% CI: 52- 70) against critical illness.  This does not vary substantially by age group.  VE
started at 76%  (95% CI: 66- 83) in the first 179 days since the last monovalent dose, with
evidence of waning early on. However, that VE at a median of 455 days or about 15 months
since the last dose remained relatively high at  56% (95% CI: 36- 69), showing the lasting
durability of COVID -19 vaccines  against the most critical illness.  Looking at these same data
broken down by time  since last dose of 7 to 179 days or 180 plus days  and number of
monovalent doses received,  there was a  slight decline  in VE by tim e since last dose, but
sustained protection overall against the most critical illness.  Substantial variation is not seen by
number of doses received in either the earlier  or the later  period.

The results  presented from both the VISION and IVY  VE Networks have  several limitations.
Regarding the estimates of absolute VE, if unvaccinated individuals are meaningfully different
than vaccinated individuals, estimates may be biased.  For interpretation  of estimates of relative
VE, residual protection from prior doses is an important  consideration and likely varies by
severity of outcomes studied.  There is limited information on prior infection,
although just as with young children, rates of prior infection in adults and older children are
known to be high.  Therefore, the VE estimates presented during this session represent a
snapshot of how well the vaccine is working under current conditions.  Finally, VE against
COVID -19-associated hospitalization from the  IVY and VISION platforms represent individuals
hospitalized with COVID- 19 disease, but may underestimate protection against critical illness.

In summary, current data from CDC  VE platforms demonstrate  that bivalent booster doses
provide added protection compared to earlier monovalent doses  against ED  and UC encounters
and hospitalizations  in adults, though there is evidence of waning protection.  For most adults,
both in the platform s shown and in the general population, more than a year has passed  since
they last received a monovalent COVID -19 vaccine.  These individuals may have limited residual
protection against hospitalization and should receive a bivalent booster dose. However, results
from the IV Y analysis show durability  of protection against the most critical COVID -19 disease
requiring IMV or causing death. CDC will continue ongoing monitoring of VE, including for all
outcomes of interest  and for all authorized vaccines in the US, including Pfizer, Moderna,
Janssen, and Novavax, with a focus  on assessing new policy recommendations and VE in
populations at higher risk of severe COVID -19 disease.

18
 Discussion Points

Dr. Chen  inquired as to why the original Wuhan strain was being included in the vaccines, given
that there is evidence the more recent doses are more effective —certainly with the bivalent
vaccines. This seemed like an opportunity to comment on thoughts about strai n match  and
selection going forward for the bivalent versus monovalent  vaccines  for mRNA  and other
vaccine constructs as well.
Dr. Link-Gelles  pointed out that the goal of this presentation was to summarize what is known
about currently available vaccines and that she would defer questions about strain selection and
the make- up of current and future vaccines  to later conversations among the ACIP and
VRBPAC.
 Referring to Slide 7 regarding monovalent vaccine, Ms. Bahta  asked whether there were any
theories  about why efficacy decreased or was not remarkable after the third dose of the Pfizer
BioNTech vaccine and there was no boost at all from the second dose.
 Dr. Link-Gelles  indicated that it was important to keep in mind  that the confidence intervals
between the estimates overlap quite a bit  so she was not sure it could be called a decrease . In
addition, the time for follow -up is quite a bit different.  For the 2- dose estimate, the analysis
looked only at  the interval before the third dose out to 3 months. The estimate for the third dose
goes out to 6 months.  That was because there were not enough children who received all 3
doses, so there was not enough power to break it down by time since dose.  Therefore, the third
dose is g etting dinged  for having more extensive follow -up time.  It is known from older children
and adults that VE against symptomatic infection wanes by time since dose.  If there were
comparable follow- up times after the second and third doses, the point estimates probably
would be more comparable.
 Referring to Slide 14 regarding hospitalization among immunocompromised adults  ≥18. Dr.
Kotton observed that while there was some overlap in the various timeframes  that showed
potential waning, it was not as much as might have been expected. She asked if there were any
thoughts about this, especially in the context of considering another bivalent booster  for th e
immunocompromised population ≥ 18.
 Dr. Link-Gelles  said she thought in part this was a precision issue, especially at the furthest
follow-up time  where the confidence interval  was quite wide and there may be missing waning
just because of that.  In addition, the immunocompromised populations being studied in these
platforms are fairly heterogeneous  and includes the span of potential immunocompromise.  It is
known from earlier studies that the vaccine works much better  in some immunocompromised
populations and worse in others, such as bone or organ transplant recipients.  In this case,
because of precision issues, there are not enough data to break it  down by type of
immunocompromise d. What this analysis was showing probably  was the result of a relatively
heterogeneous group combined with those that who probably are at highest risk of severe
COVID  being earlier adopters probably having different numbers  of monovalent doses
previously received , and different times since those monovalent doses previously received.
What she would read from this comparison  to immunocompetent individuals was  that VE is
lower at the beginning in immunocompeten t individuals  and similar patterns of waning would be
observed if broken down by some of the variables mentioned previously, which has not been possible due to precision.

19
 Dr. Long  observed that there did not seem to be much evidence of herd protection. With the
effects of bivalent vaccine boosters apparently being modest  and short -lived based on these
analyses, it seemed the hope with this kind of vaccine and disease the hope would be to protect
against death and mechanical ventilation.

Dr. Link-Gelles  agreed that the goal of the COVID -19 vaccination program is  to prevent severe
disease, including hospitalization and the critical outcomes discussed.  VE for symptomatic
infection has been shown in cases where there is a lack of data to show VE against more
severe illness.  This presentation showed VE for symptomatic infection in young children
because to date, there has not been sufficient s tatistical power to assess that against sever e
disease.

Recognizing that  there is a very small proportion of the population vaccinated and that it is
difficult to assess effectiveness with the small numbers, Dr. Long asked whether the vaccine manufacturers and possibly FDA  could comment on post-mark et Phase 4 studies  that might
address effectiveness in these populations. There continues to be a strong need for additional
data on the levels in durability of protection for children, pregnant people,  and
immunocompromised populations.

Dr. Rituparna Das  from Moderna  responded that the effectiveness work  is ongoing within the
Kaiser Permanente Southern California Health System.  Moderna presented some early data on
bivalent effectiveness  in adults during the January  2023 VRBPAC meeting and hopes to receive
an update soon on pediatric VE and the immunocompromised.  As noted, the ability to do this
will depend on the uptake in that system.

Alejandro Chevalier from Pfizer  indicated that Pfizer also is working with Kaiser Permanente
Northern California and are seeking to bring the data soon.
Updates to COVID -19 Vaccine Policy: Considerations for Future Planning
 Sara Oliver, MD, MSPH (CDC/NCIRD)  first re viewed COVID vaccine uptake over time, pointing
out that the overall population received vaccine shortly after recommendations have been
updated, but uptake overall has declined over time with additional vaccine recommendations.  In
terms of current vaccination coverage  by vaccine and age group, 1 6.7% of the population
overall has received a bivalent booster  dose to date, with higher coverage in older age groups.
However, even among adults ≥65 and over , over half of the population has  not received a
bivalent dose to date.  Regarding trends in variant proportions over time, the most recen t
surveillance shows that most isolates are related to the XBB sub- variant. Even with the newer
variants , there has not been a larger increase in cases as seen in previous years.  Looking at
overall hospitalization rates by age from COVID -NET, the highest hospitalization rates continue
to be among older adults.
 Building on what was discussed in February  2023, the goal is simple recommendations.
Aspects of this include how frequently people should get a COVID vaccine and groups or
populations who may benefit from possibly more than one vaccine a year.  During this session,
Dr. Oliver discussed steps toward simple recommendations, noting that this is a journey that
likely will include several steps.  In terms of a single formulation for mRNA COVID- 19 va ccines,
a single annual dose  possibly will be needed for most individuals , with flexibility for vulnerable
populations.  It is important to note that many of the monovalent COVID -19 vaccine products
already  have expired and others will expire soon.  FDA has removed the authorizations from
monovalent mRNA COVID19 vaccine products  and harmonization across the recommendations
20
 with the bivalent mRNA COVID- 19 vaccines was discussed at the VRBPAC  meeting in January
2023 and the ACIP  meeting in February  2023. B oth a dvisory committees expressed support.

To summarize data that  have been presented during previous ACIP meetings , the bivalent
COVID vaccines are able to induce an immune response, whether given as a primary series in
individuals who are previously unvacci nated or when given as a booster dose.  When given to
unvaccinated children, the immunogenicity data of a BA.1 vaccine induced antibody titers to
BA.1  that were 25 times higher than the original monovalent vaccine. The percent of patients
who reported local  or systemic events were similar to or less than what was seen after the
monovalent vaccine.  However, this may be a result of the larger percent of seropositive
participants in the bivalent vaccine group . There are limited data to directly compare  COVID -19
outcomes after a monovalent versus a bivalent vaccine.  Most studies showed an improvement
in neutralizing antibodies for Omicron variants with a bivalent vaccine.  However, it is difficult to
correlate  that improvement to defined clinical outcomes. W hen evaluating antigen cartography
that was presented in September  2022 , the bivalent vaccines expanded the immune response
and provided increased diversity in antibody response.  Data  from a United Kingdom ( UK) study
found around a 10% increase in VE for COVID -19 infections  with a bivalent vaccine.  The
transition will reduce the mRNA products from 11 vials to 5  vials and will eliminate the lookalike
vials between the monovalent and bivalent products.

To summa rize discussions from the last ACIP meeting, receiving COVID -19 vaccine s continues
to be important for prevention of COVID -19 severe disease,  hospitalization, and death.
However, many children and adolescents remain unvaccinated for COVID.  COVID -19 vaccine
recommendations that are simple to implement may remove some barriers to uptake.  Overall,
ACIP was supportive of a transition of the mRNA COVID -19 vaccine primary series  from
monovalent to bivalent vaccines.  As discussed earlier , FDA removed the authorization from
monovalent mRNA products.  The BLAs are still in place, but the vaccines are either expired or
have very limited doses in circulation.  At this point, the bivalent mRNA COVID -19 vaccines are
now authorized for all indications and there were no changes to the current language in the
other COVID -19 vaccine authorizations , such as Novavax  or Janssen COVID -19 vaccine s. In
terms of what this all mean s for CDC recommendations , a transition to bivalent COVID -19
vaccines could simplify presentations,  reduce  errors, and allow continued access for vaccine
with the expiration of monovalent products.  Bivalent mRNA COVID vaccines would now be
recommended for all indications.

The next step toward simple recommendations  perhaps would be a single annual dose for m ost
individuals.  Looking at data from blood donors  to assess the proportion of the population by type
of immunity and how they  have transitioned over time, the proportion has continued to decline
over time.  Overall, h ybrid immunity  has increased over time.  Separated out by age groups ,
there are 2 things to note. The proportion w ith no prior infection or vaccination is low across all
age groups  in the most recent data. The proportion with hybrid immunity , which may at this point
provide the strongest pr otection, is actually the lowest in that oldest age group.  Highlighting
timing for increases in cases or hospitalizations , overall increases have been seen during the
winter months , due to the emergence of new escape variant s, or when both have occurred at
the same time.

21
 To summariz e previous discussions  regarding the possibility of a single annual dose, future
doses for most people would be an additional boost after prior infection, prior vaccination, or
both.  An update to the benefit -risk analysis  shown in February demonstrated that time since the
last COVID -19 vaccine dose may both increase the incremental benefits of a COVID vaccine
and decrease the risk of myocarditis.  As shown by VE studies, vaccine protection likely declines
over time.  Winter months  and immune escape variants have impacted COVID -19 epidemiology.
It is known that a simplified annual recommendation could help reduce vaccine and message
fatigue.  A plan for a fall booster dose could provide added protection at a time when many
would be about a year from their last dose.  The future epidemiology in SARS -CoV-2 virus
evolution could help determine the need  for continued annual boosters.

Again, FDA authorized a single age- appropriate dose of mRNA COVID -19 vaccine for most
individuals . A singl e age- appropriate dose of a bivalent Moderna COVID -19 vaccine is
authorized for individuals ages 6 years and older who are unvaccinated, or at least 2 months
after receipt of any monovalent COVID -19 vaccine.  A single age- appropriate dose of a bivalent
Pfizer COVID -19 vaccine  is authorized for individuals ages 5 years and older  who are
unvaccinated,  or at least 2 months after receipt of any monovalent COVID -19 vaccine.

School children nearly all have had prior infection,  vaccine -induced , or hybrid immunity.  The
proportion with immunity is lower in the youngest age groups.  Based on these and other data,
some populations of young children likely still need a prime and a boost to optimize immunity.  In
addition, young children will continue to age i nto the vaccine recommendations at 6  months  and
could be SARS -CoV-2 naïve . Additional data are forthcoming  to evaluate the benefits of a multi -
dose primary series in all children ages 5  and younger,  or if those recommendations could be
simplified further. The WG looks forward to presenting a cost -effectiveness  analysis in children
and additional antibody data in children during f uture ACIP meetings.  In the pediatric population,
FDA has authorized 1 , 2, or 3 doses of a bivalent vaccine for  children  6 months through 4 or 5
years.  The number of doses depends on age and the number and type of prior COVID -19
vaccines received.

The overall implications for CDC recommendation s are that a COVID -19 vaccine framework for
a single dose could be easy for COVID -19 vaccine providers to implement  and for the public to
understand. The current recommendation for a single dose may evolve over time and could
move to an annual recommendation. With these updates, a single bivalent dose would be
recommended for everyone ages 6 years and over. For most people, the implication of this
update means no change, and. the actions taken after this are exactly the same.  If someone
has not received a bivalent vaccine yet, they  are recommended to receive one regardless  of
their previous vaccine history. C hildren  6 months through 5 years  of age would receive at least
2 COVID -19 vaccine doses , including at least 1  bivalent vaccine.  Detailed guidance for this will
be published in the I nterim Clinical Considerations.

In terms of fl exibilit y for vulnerable populations, the rates of hospitalization for those 65 years of
age and over have seen several increases over the past year.  Unlike what was seen previously
in the pandemic, these increases have not been near ly as high in the other younger  age groups
as they were earlier.  However, rates of COVID -19 death  by vaccination status among older
adults 65─ 74 years of age and ≥ 80 years of age are highest among the unvaccinated and
lowest are among those with an updated or bivalent booster dose.  Many  adults who already
received a bivalent booster dose  were eager for the option to receive another one. In a survey
22
 of boosted adults in January,9 over half said that they were awaiting new guidelines for
additional doses and 86% said that they felt it was an important or top priority  to receive
additional doses. While it is know n that many in the population are experiencing vaccine fatigue,
there is a subset who are eager to continue to receive additional doses.

To summarize overall  what was discussed in February, it is known that older adults continue to
have higher rates of hospitalization than younger adults. Among older adults, vaccination rates
with bivalent COVID -19 vaccines remain low and it is known that it is critical for older adults to
be up- to-date on current recommendations, including receiving a bivalent booster. ACIP
discussed that at the time, the data were insufficient  to support a routine recommendation for
older adults to receive a COVID vaccine dose every 6 months long- term,  but acknowledged that
the population may continue to be more vulnerable to severe COVID -19 and likely needs
flexibility with COVID -19 vaccine recommendations.  Updates from FDA ’s authorizations for
adults ≥65 years  of age are that  a single dose of a bivalent mRNA COVID vaccine, either Pfizer
or Moderna , may be administered at least  4 months following the first bivalent dose.  In terms of
implications for CDC recommendations , bivalent COVID -19 vaccines continue to provide
protection against severe disease and rates  of hospitalization or death among adults who have
received a bivalent booster continue to be low.  However, some older adults may  benefit from an
additional updated COVID -19 vaccine dose prior  to future recommendations for updated
vaccines this fall. Adult ≥65 years of age may now choose to receive another updated COVID-
19 vaccine dose if it has been 4 months since their first bivalent dose.
 For immunocompromised persons, data  presented in February  showed that
immunocompromised adults can have a less robust immune response to COVID- 19 vaccines.
Unfortunately, there are no currently authorized prophylactic monoclonal antibody products for
populations  at highest risk for COVID -19. ACIP discussed that while the data were insufficient  to
support a routine  recommendation for people who are immunocompromised to receive a COVID
vaccine every 6 months long- term,  they acknowledged that this population continues to be
vulnerable and needs flexibility with COVID -19 vaccine recommendations.  FDA has provided
that fl exibility. For people who are immunocompromised, additional doses have been
recommended previously and current updates continue to allow additional protection to a
vulnerable population. Updates also allow flexibility to adjust to an individual’s specific
circumstances, including timing of immunosuppression as well as the possible need for re -
vaccination after particular events (e.g., stem cell transplant) . Additional guidance is to be
published in Interim Clinical Considerations . People who are immunocompr omised may choose
to receive another updated COVID -19 vaccine dose  and have the flexibility to receive additional
doses based on their clinical circumstances.

To recap, steps toward the goal  of simple recommendations include the single formulation
mRNA CO VID-19 vaccines  and a single (possibly annual) dose for most individuals , with
flexibility for vulnerable populations . However, this cannot be achieved in a single action, so it is
important to acknowledge that future steps may be possible.  While the updates during this
session were focused on mRNA vaccines, it may be possible to s implif y all COVID -19 vaccines.
While looking to the possibility of updated vaccines this fall, the WG will continue to evaluate
data- driven ways to simplify the pediatric program and present related data during upcoming
meetings. As always, the goal will be to continue to work toward a goal  of flexibility and simple
guidance.

9 KFF COVID -19 Vaccine Monitor: January 2023. https://www.kff.org/coronavirus -covid -19/poll -finding/kff -covid -19-vaccine -monitor-
january -2023/  A ccessed February 7, 2023
23
 In summary, COVID -19 vaccines continue to be the most effective tool available to prevent
serious illness, hospitalization, and death from COVID- 19. Simple recommendations are easier
to communicate, which may improve uptake.  It is anticipated that an updated fall vaccine could
be available. The WG will continue to review data  to inform possible recommendations. Based
on available data at this time , it is anticipated that there would be benefits of COVID- 19
vaccines this fall. U pdates to COVID -19 vaccine policy also can acknowledge the  possibility of
future recommendations. For most individuals,  the current doses needed remain unchanged. A
single bivalent vaccine is recommended and there could be an updated vaccine and
recommendations this fall.  In direct response to feedback from previous discussions, there is
flexibility  for vulnerable populations in the current recommendations. Young children continue to
be recommended for multiple doses for the prime/ boost immune response. The WG will
continue to review additional data to optimize those recommendations.

To summarize the WG discussions  overall: the WG will continue to review data and evaluate the
COVID -19 vaccine program in the context  of evolving epidemiology. To date, the COVID- 19
Vaccine WG has had 112 calls  in which they have reviewed the data and discussed the COVID-
19 vaccine program. Early COVID -19 vaccine recommendations were made in light of a highly
susceptible immune- naïve population who had limited treatment options.  Increases in
population- level imm unity through vaccine and infection, SARS -CoV-2 virus evolution,
availability  of antiviral treatments, and the review of COVID- 19 epidemiology and hospitalization
rates can lead to evidence- based updates  in vaccine policy. This does  not change decisions
that were made then but highlights that the program can continue to evolve as these data
evolve as well.  Work will be ongoing to review additional data and continue efforts for
simplification.  When reviewing the totality of the data, the WG was supportive of  simplified
recommendations  and flexibility for vulnerable populations.

Updates to Interim Clinical Considerations for Use of COVID -19 Vaccines
 Evelyn Twentyman, MD MPH (CDC/NCIRD)  presented updates to the Interim Clinical
Considerations for the use of COVID -19 vaccines that are anticipated as a result of the
authorized revisions the previous day. First, these new recommendations are simple and
singular for most people.  The previous recommendations  were for people ages 6 through 11
years without immunocompromise, including specific recommendations  for a primary series and
booster , with variation by age and by product.  The new recommendation for people aged ≥6
years  without immunocompromise who have not yet received a bivalent mRNA dose is
extremely simple:  receive one bivalent mRNA dose  regardless of COVID -19 vaccination history.
The good news  is that vaccination is complete for people who already have received a bivalent
Pfizer or Moderna mRNA dose  and no doses are indicated at this time.

The new recommendations also offer flexibility for people at higher risk.  One of the groups of
people at higher risk of severe COVID -19 disease is people ages 65 years and older.  People
ages 65 years and older who have not yet received a bivalent mRNA dose  are recommended to
receive that dose. Additionally, they have the option of receiving an additional bivalent mRNA
vaccine dose when  it has been at least 4 months following their first bivalent mRNA dose. That
means that those aged 65 years  and older who  have already received a bivalent mRNA dose,
for example, who received their updated booster when they were authorized in September  2022
or sometime thereafter, are already up to date.  Vaccination is complete.
With the new flexible recommendations, they have the option  of receiving an additional bivalent
mRNA vaccine dose when it has been at least 4 months following the initial bivalent dose.  There
also is flexibility for people at higher risk of severe COVID -19 disease due to
immunocompromise.  For those people aged  6 years and older who have already received a
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 bivalent mRNA dose,  an optional additional bivalent mRNA dose may be administered at least 2
months after their first bivalent mRNA dose and additional bivalent mRNA doses may be
administered as needed.  The changes additionally offer  customized recommendations for
young children as illustrated here. The new recommendations are customized by COVID -19
vaccination history  such that all children receive at least 2  vaccine doses in total, including at
least 1 bivale nt dose.  This flow chart  was developed to depict how to easily determine what
customized recommendation is  relevant to a child given their personal COVID -19 vaccine
history.  For the Interim Clinical Considerations to be posted to the CDC website, a  complet e
table has been developed of the recommendations for vaccine doses moving forward,  given any
particular history of COVID -19 vaccination:

The other group of children who have customized recommendations are 5 -year-olds. These
recommendations are extremely similar to those for children ages 6  months through 4  years :

25

To summarize it means to be up -to-date with COVID- 19 vaccines in the context of the new
recommendations , adults and children aged 6 years and older are up- to-date with COVID -19
vaccines if they got a bivalent (updated) COVID -19 vaccine.  Children 6 months through 5 years
of age who received the Pfizer -BioNTech COVID -19 vaccine are up -to-date if  they are 6 months
to 4 years of age and got at least 3 COVID -19 vacci ne doses, including at least 1 bivalent
(updated) COVID -19 vaccine dose or they are 5 years of age and got at least 1 bivalent
(updated) COVID -19 vaccine dose.  Children 6 months through 5 years of age who got the
Moderna COVID -19 vaccine are up -to-date if they got at least 2 Moderna COVID -19 vaccine
doses, including at least 1 bivalent (updated) COVID -19 vaccine dose. Persons may be eligible
for additional COVID -19 vaccine doses if  they are 65 years of age and older and got their first
bivalent (updated) CO VID-19 vaccine booster 4 or more months ago and/or are moderately or
severely immunocompromised and received a bivalent (updated) COVID -19 vaccine booster 2
or more months ago.  Someone who is unable or chooses not to get a recommended bivalent
mRNA vaccine  will be up -to-date if they got the Novavax COVID -19 vaccine doses approved for
their age group.

In terms of implications for vaccine providers, the  new recommendations result in fewer total
COVID -19 vaccine products in use,  which might be very helpful for vaccine providers. There will
now be 5  total bivalent products in use and 1 monovalent product in use. The supply of the 1
remaining monovalent COVID -19 vaccine will be expired on May 6, 2023. Additional help for
providers i s on the way.  CDC is working to serve providers the very best way possible. Interim
Clinical Considerations are being updated with comprehensive tables of vaccine doses  and
dosages indicated for each age group, and by history of COVID -19 vaccines received  for
children aged 6  months through 5  years. CDC is working to revise additional clinical guidance
materials and will present these new recommendations and their implications for providers in
greater depth during an upcoming Clinician Outreach and Communica tion Activity (COCA)  call
on May 11, 2023.
 In terms of implications for public health , one of the most important messages  is that although
the new recommendations are simplified and although everyone ages 6  years and older will
now be up- to-date following  receipt of an updated mRNA vaccine, m ost people in the US have
not yet received an updated mRNA vaccine. Just 16.7%  of the entire  US population and just
over 20% of adults  or 4 out of 5 adults have not  yet received a bivalent mRNA vaccine and are
not up -to-date with COVID -19 vaccination at this time.  Bivalent COVID- 19 vaccine coverage
tends to decrease  with decreasing age . Unfortunately , coverage is not even 50% among people
ages 65 years or older  who may be at higher risk of severe COVID -19 disease because of their
age. Unfortunately, racial disparities in receipt  of bivalent mRNA vaccines persist . Bivalent
COVID  vaccine  coverage is lowest among Black, non- Hispanic , Hispanic /Latino, and N ative
Hawaiian or other Pacific Islander populations.  It also is important to point out that bivalent
COVID -19 vaccine coverage is lower among  those with lower income. It is evident that providing
these vaccines free of cost to the recipient has not yet resulted  in equitable coverage by
income.  Unfortunately, bivalent  COVID -19 vaccine coverage is also lower  among those without
health insurance. It is important to underscore here that a person does not need to have health
insurance in order to receive a bivalent COVID -19 vaccine.  It does appear that there is still work
left to be done in achieving equitable coverage for those without health insurance.

To provide some reflections and next steps , COVID -19 vaccines continue to be the most
effective tool to prevent serious illness, hospitalization,  and death from COVID -19. However,
uptake of the updated bivalent COVID -19 vaccines is not yet equitable and remains generally
26
 low. Simple recommendations are easier to communicate,  which hopefully may improve vaccine
uptake.  CDC is continuing to work toward additional materials  for vaccine providers, clinicians,
and the general public to make it easy for everyone to get up-to-date and stay up -to-date with
COVID -19 vaccines.

Discussion Points  (Oliver & Twentyman)

Ms. Bahta  asked whether ethnic  and racial background information related to hospitalization
and death  are available and expressed concern that there might be  a missing gap of individuals
who are vulnerable between 50 to 65  years of age.

Dr. Oliver recalled a presentation in February from the COVID -NET team,  which is where those
data come from at CDC. While she did not remember specifically whether those data showed race and ethnicity , she will engage in discussions  looking forward to future meetings to
determine whether additional data can be provided on that.
Based on the comments  that have been made via the Federal Registry, Ms. Bahta pointed out
that it is important to understand why the recommendations  are not being updated and
especially why there is no booster for Novavax.  While Dr. Marks addressed thi s, she thought it
was important to re -explain that.
 Dr. Twentyman indicated that there is a Novavax booster that is authorized in some  situations,
specifically including among those who are unable or unwilling to receive a bivalent mRNA
vaccine dose and who have not received previous booster doses. This is part of the
authorization of that vaccine dose and is why it is stated as such. In terms of updating the
Novavax vaccine itself, she called upon the sponsor to comment.

Dr. Raburn Mallory, Novavax , indicated that they are working to provide an updated vaccine for
the upcoming full winter season.  They have been engaged in discussions with the FDA and
other regulatory authorities about what kind of updates might be made to the vaccine.

Dr. Kotton  asked whether the FDA could provide any additional explanation for children who are
immunocompromised regarding the number  of vaccine doses that they can receive, which
seemed somewhat different from what ACIP had been thinking.  In addition, she asked whether
there would be additional guidance from FDA or CDC through Clinical Considerations.  While
she understand that the intent was  to provide an individual clinician flexibility with some of the
more extenuating circumstances, she wondered if there would be any specific language
provided regarding that, because as an immunocompromised host  provider, she was not
necessarily entirely c lear on what the flexibility actually would provide.
 Dr. David Kaslow, FDA, indicated that immunocompromised children  and adults  can receive an
additional bivalent dose after they  have gotten their first bivalent dose. FDA has provided
flexibility  for additional doses at the discretion of the HCP  and taking into consideration an
individual ’s clinic al circumstances.
 Dr. Twentyman clarified that Moderna recipients ages 6 months through 5 years  of age have the
option to receive further additional doses  of bivalent Moderna COVID- 19 vaccine as informed by
the clinical judgment of a HCP,  personal preference, and circumstances. T hose ages 6 years
and older who received Moderna  also have the option to receive further additional age-
appropriate doses of bivalent Moderna COVID -19 vaccine as informed by the clinical judgment
of a HCP, personal preference, and circumstances.  Pfizer recipients ages 5 years and older
27
 have the option to receive further additional age -appropriate doses of bivalent Pfizer  COVID -19
vaccine  informed by clinical judgment, personal preference, and circumstances.  Novavax
recipients ages 12 years and older have the option to receive further additional age- appropriate
doses of bivalent mRNA COVID -19 vaccine informed by th e same considerations.  Children 6
months through 4 years of age who are immunocompromised who received Pfizer are not
perceived to be authorized at this time.

Dr. Marks  emphasized that the FDA has to make decisions based on data and there were no t
sufficie nt data to support the  additional dose. Updates will be made when data are available.
That means that immunocompromised children  6 months through 4  years of age who had a
prior Pfizer  dose cannot receive additional vaccine doses moving forward until such t ime as
FDA has the data , which is anticipated to be toward the fall vaccination campaign once strain
selection is decided.

Dr. Kotton stressed that this potentially leaves this immunocompromised vulnerable population
at higher risk  for at least the next 6  months, which sounded potentially devastating for a high-
risk immunocompromised population.  Certainly, during the pandemic there have been times
when the best decisions  have been made at the time based  on the preponderance of data in the
interest of publi c health.  She spoke strongly in favor of trying to protect this vulnerable pediatric
population.

Dr. Marks indicated that FDA is happy to take this into consideration and to speak with their
CDC colleagues.

Regarding the bivalent Moderna being a lower do se than the primary series, Dr. Lee asked what
the potential impact would be now that the lower bivalent dose would be allowed for use as a primary series even though an additional dose is allowed. Immunocompromised children and
adult patients are presenti ng with severe consequences and have been hospitalized for
prolonged periods of time.  For the immunocompromised population,  there are not good choices
right now or the data to support that it will be possible to optimally protect that population. Given
that, she asked what guidance FDA would give providers who are caring for these patients .
 Dr. Marks replied that they allowed the additional dose for Moderna  because of the way
previous doses were administered and the situation they were  in. It was a challenge to sort out
what  would be best to do,  given the various dos es of the vaccine that were  used in the initial
series and in subsequent ones.  FDA will take this under advisement .
 Dr. Lee emphasized the need to highlight the gap that Dr. Kotton identified and provide some
guidance to clinicians about how to manage these patients because right now, there are not
optimal ways to protect those who are immunocompromised who are 5 years of age and
younger.

Dr. Das , Moderna,  responded that the primary  series is  25μg  for children, but the booster dose
is 10 μg for children 6 months to 5 years of age. The 10μg  bivalent booster dose is also the dose
for 6 years of age plus.  Dr. Lee noted that the question would be whether to provide the 25μg
dose for those  who might be immunocompromised if they are felt to need the additional doses
versus the one that  is now approved  for those 6 months to 5 years of age.

Dr. Sanchez  expressed appreciation for the flexibility, echoed what had been said about
immunocompromis ed children, and agreed that clarification  was needed.  Given VE in
immunocompetent children with the Pfizer and Moderna product s, he would think  that
28
 immunocompromised children need further dosing  and would appreciate  not only  further , but
also more protec tion in that age group.  In terms of scheduling, the bivalent dosing of 10μg was
still confusing to him.

Dr. Twentyman indicated that this would be addressed in the forthcoming Interim Clinical
Considerations. CDC is creating a table of precise dosage by both microgram ,  intervals by age,
and COVID -19 vaccine history  so that providers will be able to look up exactly where their
patient is sitting on the  table  and provide exactly the dosage indicated from the vial indicated.  To
speak to the Moderna issue , the chart indicates that children 6 months to 4 years of age who
have not previously received COVID -19 vaccine are recommended to receive 2 doses of
Moderna COVID -19 bivalent vaccine at a dosage of 25  μg from the dark blue cap gray label
bordered vial at an interval of 4  to 8 weeks  between Dose 1 and Dose 2. That is just one
example, but the plan is to provide this guidance  for every age and by history where relevant
among children ages 6  months through 5  years.  The 10μg  dose  remains  in use for chi ldren with
a history of receipt of  2 doses  of monovalent Moderna COVID -19 vaccines. In other words, that
recommendation has not changed from the previous  recommendation, and they can receive the
10μg  dose from the existing booster dose vial for that age group.

Dr. Marks, FDA, clarified that for the Moderna vaccine, children between the ages of 6  months
and 4 years have received 2 doses at 25μg . As in some adult situations,  there can be a  third
dose given to the immunocompromised at the  same 25μg  dose. A third 25 μg dose of Moderna
may be given in that population. I mmunocompromised children who have  not received any
doses could receive up to the 3 doses of Moderna at 25μg  each . That information is included in
the Fact Sheet.
 Dr. Caine  pointed out that the Biden Administration has a B ridge program  for the 30 million
uninsured adults, and there is an effort to get funding for the vaccine for adults.  One of the
slides showed that only 9% of Blacks overall have had bivalent COVID -19 vaccine. She asked
whether there are any recommendations  and/or funding from ACIP for community -based
organizations  (CBOs) engaged in outreach to get folks vaccinated. She is concerned about
those who are not connected to a medic al home  such as FQHCs  or providers  and about how to
get them connected to a medical home . Also concerning is that there has been a substantial
increase in undocumented immigrants.

Dr. Peacock  indicated that throughout the pandemic, a fairly large amount of funding has been
provided to CBOs and various state  and local health departments to focus on this type of work.
One of the activities that CDC has  funded is  through the Partnering for Vaccine Equity (P4VE)
program.  That is COVID -19 supplemental f unding that is  still in place and is  scheduled to go
through FY24.  CDC is continuing to work with  CBOs, which is a critical need.  Overall, there has
been fairly low uptake of updated vaccine and a lot of work needs to be done to improve
confidence and acce ss for these vaccines.

Dr. Hacke ll seconded the comments about addressing pediatric patients whose age group
changes, especially during the Moderna primary series because the dose is different.
Pediatricians  often are asked a lot of  questions by families,  parents, and grandparents .
Anticipating a possible update in the vaccine in the fall  and thinking about whether the optional
second booster should be received now , there could be an impact on eligibility for a booster in
the fall if the composition  of the  vaccine changes .

29
 Dr. Oliver emphasized that changes are being made to the recommendation in anticipation that
there still may be additional changes this fall. Overall, especially for children,  the additional
doses that would be recommended would be for immunocompromised people.  This would be up
to the clinician , but if there is a de sire and potential benefit, especially based on the level of
immunocompromise,  then she would encourage someone to get all available doses.  It is not
anticipated that getting a dose now would preclude somebody from getting a dose in the fall.
Reasonably healthy  and perhaps older adults may want to wait until  the fall , which is an option.

To clarify some continuing confusion, Dr. Twentyman explained that the transition from the era
of monovalent mRNA vaccines  to bivalent mRNA vaccines is slightly different for 5- year-olds
because these children were previously recommended to receive either 2 or 3 primary series
doses and then  at least 1 bivale nt dose. For 5- year-olds who have started the Moderna series ,
there are now customized recommendations to make sure that they all receive at least 2
vaccine doses in total,  including at least 1 bivalent dose.  Pfizer recipients who have turned age
5 who received Pfizer or who will receive Pfizer have the very simple recommendation of
receiving a single bivalent dose.

PUBLIC COMMENT

Overview

The floor was opened for public comment on April 19, 2023 at 1:30 PM ET. Given that many
more individuals registered to make oral public comments than could be accommodated during
this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle reminder that
the ACIP appreciates diverse viewpoints that are respectful in nature and issue- focused. The
comments made during the meeting are included in this document. Members of the public also were invited to submit written public comments to ACIP through the Federal eRulemaking Portal
under Docket ID CDC- 2023-0028. Visit http://ww w.regulations.gov
 for access to the docket or to
submit comments or read background documents and comments received.

Public Comments
 Donna Treubig
Licensed Child Care Provider
Family Traditions Child Care

Thank you. Hello. I am a licensed childcare owner /provider.  I have worked very hard over the
last 3 years and continue to work to protect the very young children I care for , including my
young grandchildren , from this virus. I have no conflicts.  I'm also a proud  member of Protect
Their Future, a non -profit grassroots advocacy organization made  up of parents, doctors , and
scientists d edicated to ensuring that children are prioritized regarding the development  of
vaccines. While I am a member, the following comment s are my opinions.  Our children need
your commitment to the early approval of the next round of fall vaccines before school starts in
August. We need all children, including children under 5, to be vaccinated and have immunity
before starting school and daycare this fall.  Please simplify the process. Families across the
country are actively looking to vaccinate their young children, but pharmacies will not administer
them and pediatric offices cannot manage a large stock of vials.  All vaccine trials and nex t
generation solutions should include all age groups simultaneously.  We know that the vaccines
are safe and effective. We also know  from the data that children  under 1 are at a higher risk for
COVID  complications. Babies cannot wear a mask to protect themselves.  Even based on
30
 today ’s discussion , please do not continue to leave them behind.  It would be beneficial for those
who haven't been infected, pregnant women, people with high BMI, and others to have access
to another bivalent booster before the late summer spike.  There shouldn't be an age range  or
immunocompromised requirement  to get a second bivalent booster today. It is too early to move
to a once- a-year flu shot -type schedule for COVID . COVID  is still mutating.  The vaccine
manufacturers need to be ready and free to produce a variant specific booster  that is quickly
available to all age groups. Thank you very much.

Ms. Crescent Martin
Pregnant Person

Good afternoon and thank you for the chance  to comment today.  I urge the ACIP and CDC , in
coordination with colleagues at FDA as needed,  to immediately grant pregnant people
permissive  access to an additional COVID  booster based on their pregnancy status. Recently ,
the WHO updated its recommendations  to include pregnant people as a high priority group and
to recommend that pregnant people receive an additional  booster dose if their last dose was
more than 6  months ago. I was heartened to hear Dr. Sara Oliver state at the February ACIP
meeting that a deeper dive into the emerging data on vaccination among pregnant individuals,
with a view towards assessing what data is needed to make recommendations for that
population, is  among CDC ’s top priorities for upcoming meetings.  But I'm here to remind you
that people who are currently pregnant do not have the luxury of waiting for full consideration of
all of the emerging data.  I received a bivalent booster as soon as I could get an appointment in
September —more than 7 months ago.  I'm currently in my third trimester of pregnancy  and I
recently received a Tdap  booster as recommended to protect my infant against whooping
cough.  However , under current restrictive US authorizations, I'm not eligible to receive an
additional COVID  booster  to maximize the mate rnal antibodies I could be passing on to my
infant. These antibodies could help reduce her risk  of serious COVID  complications before she
is eligible for her own vaccination. For context , this is my second pandemic pregnancy.  My first
pandemic baby was bor n in Summer 2020, a truly scary time to be pregnant , before any
vaccines were available.  My family tried hard to shield my son from getting COVID  until after he
was finally eligible  to be vaccinated in June 2022. In large part , our concerns were about the
unknown long- term consequences of infection with a novel pathogen , especially with a naïve
immune system. In 2023 , we're now fortunate to have the tools of vaccination and so it should
be much easier to protect this pandemic baby. However , the current move to an annual
vaccination schedule does not have enough flexibility to optimally protect the vulnerable groups
of pregnant people and infants under 6  months. As we wait for sufficient evidence to support an
affirmative policy recommendation that a COVID  booster is absolutely necessary in each
pregnancy, we do have very strong safety data.  The currently available evidence suggests that
the known and potential benefits of an additional booster are likely much higher  than the known
and potential risks. It woul d be a reasonable choice under a shared clinical decision- making
model for a pregnant person to choose an additional booster dose during pregnancy. CDC and
FDA policy should not stand in the way of that decision, but instead should ensure that pregnant
people have authorized access to additional booster dose if they wish to receive one.  This, of
course,  is in addition to continuing to promote and provide access to vaccination for the many ,
many pregnant people who are not otherwise up- to-date. Thank you for your consideration and I
look forward to hearing your discussion this afternoon.

31
 Dr. Jonathan Vi gh
Project Scientist
National Center for Atmospheric Research

Thank you so much, Dr. Lee and ACIP members. Thank you for the opportunity to provide input
on this very important subject. I'm a Project Scientist at the National Center for Atmospheric
Research in Boulder, Colorado. I'm also a wildfire survivor. My family lost their home in the
Marshall Fire. My 2 children attend elementary school here in Colorado and there has been a
frightful amount of illness at their school this year, inc luding COVID, RSV, flu, and strep.
Although no one in my family has tested positive for COVID so far, my son has been sick for
weeks and we worry he could be suffering from post -viral syndrome. I've learned that resilience
is vital, and that health cannot be taken for granted. I had Moderna for my first 3 vaccinations.
After my second shot, I experienced a strong reaction which included fever, malaise, heart
palpations, and chest pain. My first booster was only somewhat better. It was miserable to have
to miss a day of work each time I got vaccinated. Last fall, I was due for my second booster, so I
decided to try Novavax. The difference was night and day. The only side effects I experienced
were a sore arm, a slight tingle in my scalp, and feeling a little tired in the evening. I was able to
work the next day and for me,  Novavax was a game changer. From everything I've heard, I
understand that Novavax's monovalent vaccine has effectiveness on par with the bivalent
vaccines. Recent real -world data shows that the mRNA protection starts strong and begins
fading as early as 4 months. In contrast, Novavax offers durable,  lasting protection and
excellent protection against severe disease with fewer side effects. Also, many people suffering
long- COVID have reported that Novavax improved their symptoms. The weight of evidence that
we have in hand shows that Novavax is an effective and safe vaccine. Therefore, it is
inexplicable why the current guidelines make it nearly impossible for Americans to get Novavax as a seco nd booster. I have not seen any scientific justification that supports this restriction. I'm
asking for 4 changes to vaccine immunization practice today: 1) Please allow all age groups to get vaccinated more than once per year , if desired; 2) Please speed up the timeline for kids
under 12 to be able to get Novavax. I would like my kids to get it; 3) allow kids to get their
booster a full month before the school year starts; and 4) Please, please change the guidelines
to allow people to get Novavax without r egard to their previous vaccination history. We won't
achieve full vaccine equity until all Americans have the freedom to choose the vaccine that is
best for them. Once we achieve this, I believe that we will see improved uptake of boosters.
This will move  the needle toward stopping transmission and finally ending this pandemic. Thank
you very much.

Ms. Gwendolyn Kull
Attorney & Contributing Author
Brownstone Institute

Thank you. M y name is Gwendolyn Kull, I'm an A ttorney and a C ontributing Author for
Brownstone Institute.  I'm here today to speak about the policy requiring COVID -19 vaccination
for foreign travelers to the United States.  And for those of you who might not be aware, the CDC
has an A mended Order mandating that all travelers , non-citizen, non -immigrants , to the United
States be vaccinated before boarding an airplane. If this policy were truly for preventing disease,  shouldn't we instead mandate testing? This policy has failed at its purpose and is
costing thousands, precious time with their family members , and the US economy billions in
revenue. As of August 19, 2022 , the CDC public policies should not  differentiate by a person’ s
vaccination status  because of breakthrough infections. Yet this policy continues, leaving those
of us harmed by it  to question why.  Vindictive punishment for the exercise of medical autonomy
or religion? The CDC has a duty to the American public  and the US Constitution to rescind the
32
 policy regardless of President Biden's proclamation because it is unconstitutional. I t is an
unlawful delegation under T itle 3 since Director Walensky was not appointed through Senate
confirmation. It is not rationally related to the purpose of disease prevention since vaccines do
not prevent the disease, a nd it further causes families to be separated.  It oversteps authority
vested by Congress under the Administrative Procedures Act by creating additional
requirements for entry  into the United States than are actually legislated under T itle 8, Section
1182a, w hich only requires proof of vac cination against vaccine -preventable diseases prior to
entry.  Even if the vaccine did prevent disease, the policy is still ineffective because it doesn't
apply to Americans who can travel nearly anywhere in the globe unvaccinated,  free to transmit
the disease. In reality, the policy fails  because the vaccines do not prevent disease and it allows
people with active COVID  infections to fly  to the US so long as they present proof of
vaccination. As a result of this policy , bi-national families have been  kept a part—some for more
than 3 years. Unvaccinated visa holders living in the United States have been trapped here for
fear they will be denied re- entry and lose their jobs or education. Tourists choose non- US
destinations.  The vaccine is now also senselessly on the immigration schedule for adults and
children, again violating 1182a and the PREP Act.  Probable reciprocity is not maintained with
other nations and the US lost nearly $100 billion between lost tourism revenue and the cost of
enforcement in the last year alone. Stop wasting resources and taxpayer dollars on this moot
and unlawful policy that's causing real harm to innocent , healthy people while not preventing
transmission.  Resend the amended order implementing P roclamation 10294. T hank you .

33
 CERTIFICATION

Upon reviewing the foregoing version of the April 19, 2023 ACIP meeting minutes, Dr. Grace
Lee, ACIP Chair, certified that to the best of her  knowledge, they are accurate and complete.
Her original, signed certification is on file with the Management Analysis and Services Office
(MASO) of CDC.

34

ACIP MEMBERSHIP ROSTER

CHAIR
LEE, Grace M, MD, MPH
Associate Chief Medical Officer for Practice Innovation
Lucile Packard Children’s Hospital
Professor of Pediatrics, Stanford University School of Medicine  Stanford, CA
Term: 8/4/2021 – 6/30/2023

EXECUTIVE SECRETARY
WHARTON, Melinda, MD, MPH
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Atlanta, GA

MEMBERS
BAHTA, Lynn, RN, MPH, CPH
Immunization Program Clinical Consultant
Infectious Disease, Epidemiology, Prevention & Control Division
Minnesota Department of Health
Saint Paul, Minnesota
Term: 7/1/2019 – 6/30/2023

CHEN, Wilbur H, MD, MS, FACP, FIDSA
Professor of Medicine  Center for Vaccine Development and Global Health
University of Maryland School of Medicine
Baltimore, MD
Term: 12/23/2020 – 6/30/2024

DALEY, Matthew F, MD
Senior Investigator   Institute for Health Research, Kaiser Permanente Colorado
Associate Professor of Pediatrics
University of Colorado School of Medicine
Aurora, CO
Term: 1/4/2021 – 6/30/2024

KOTTON, Camille Nelson, MD, FIDSA, FAST
Clinical Director, Transplant and Immunocompromised Host Infectious Diseases
Infectious Diseases Division, Massachusetts General Hospital
Associate Professor of Medicine, Harvard Medical School
Boston, MA
Term: 12/23/2020 – 6/30/2024

35
 LOEHR, Jamie, MD, FAAFP
Owner, Cayuga Family Medicine
Ithaca, New York
Term: 7/26/2021 –  6/30/2025

LONG, Sarah S, MD
Professor of Pediatrics
Drexel University College of Medicine
Section of Infectious Diseases
St. Christopher’s Hospital for Children
Philadelphia, Pennsylvania
Term: 12/24/2020 – 6/30/2024

MCNALLY, Veronica V, JD
President and CEO Franny
Strong Foundation
West Bloomfield, Michigan
Term: 10/31/2018 – 6/30/2022

POEHLING, Katherine A, MD, MPH
Professor of Pediatrics and Epidemiology and Prevention
Director, Pediatric Population Health
Department of Pediatrics
Wake Forest School of Medicine
Winston- Salem, NC
Term: 7/1/2019 –  6/30/2023

SÁNCHEZ, Pablo J, MD
Professor of Pediatrics
The Ohio State University –  Nationwide Children’s Hospital
Divisions of Neonatal -Perinatal Medicine and Pediatric Infectious Diseases
Director, Clinical & Translational Research (Neonatology)
Center for Perinatal Research
The R esearch Institute at Nationwide Children's Hospital Columbus, Ohio
Term: 7/1/2019 –  6/30/2023

TALBOT, Helen Keipp, MD
Associate Professor of Medicine  Vanderbilt University
Nashville, TN
Term: 10/29/2018 –  6/30/2022

36

EX OFFICIO MEMBERS

Centers for Medicare and Medicaid Services (CMS)
HANCE, Mary Beth
Senior Policy Advisor
Division of Quality, Evaluations and Health Outcomes
Children and Adults Health Programs Group
Center for Medicaid, CHIP and Survey & Certification Centers
for Medicare and Medicaid Services
Baltimore, MD

Food and Drug Administration (FDA)
FINK, Doran, MD, PhD
Deputy Director, Clinical, Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Silver Spring, MD

Health Resources and Services Administration (HRSA)
RUBIN, Mary, MD  Chief Medical Officer
Division of Injury Compensation Programs
Rockville, MD

Indian Health Service (IHS)
CLARK, Matthew, MD, FAAP, FACP
Physician
Chair, IHS National Pharmacy & Therapeutics Committee
Durango, CO

Office of Infectious Disease and HIV/AIDS Policy (OIDP)
KIM, David, MD, MA
Director, Division of Vaccines, OIDP
Office of the Assistant Secretary for Health
Department of Health and Human Services
Washington, DC

National Institutes of Health (NIH)
BEIGEL, John, MD
Associate Director for Clinical Research
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, MD

37
 LIAISON REPRESENTATIVES

American Academy of Family Physicians (AAFP)
ROCKWELL, Pamela G, DO
Associate Professor, Department of Family Medicine, University of Michigan Medical School
Medical Director, Dominos Farms Family Medicine
Ann Arbor, MI

American Academy of Pediatrics (AAP)
MALDONADO, Yvonne, MD
Senior Associate Dean for Faculty Development and Diversity
Professor of Pediatrics and Health Research and Policy  Chief, Division of Pediatric Infectious Diseases
Stanford University School of Medicine
Stanford, CA

American Academy of Pediatrics (AAP)
Red Book Editor
KIMBERLIN, David, MD
Professor of Pediatrics
Division of Pediatric Infectious Diseases
The University of Alabama at Birmingham School of Medicine
 Birmingham, AL

American Academy of Physician Assistants (AAPA)
LÉGER, Marie -Michèle, MPH, PA -C
Senior Director, Clinical and Health Affairs
American Academy of Physician Assistants
Alexandria, VA
American College Health Association (ACHA)
CHAI, Thevy S., MD
Director of Medical Services
Campus Health Services
University of North Carolina at Chapel Hill Chapel Hill,
NC

American College Health Association (ACHA) (alternate)
MCMULLEN, Sharon, RN, MPH, FACHA
Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health
Ithaca, NY

American College of Nurse Midwives (ACNM)
HAYES, Carol E., CNM, MN, MPH
Lead Clinician
Clinical Quality Compliance and Management
Planned Parenthood Southeast  Atlanta, GA

38
 American College of  Nurse Midwives (ACNM) (alternate)
MEHARRY, Pamela M., PHD, CNM
Midwifery Educator, Human Resources for Health
In partnership with University of Rwanda and University of Illinois, Chicago

American College of Obstetricians and Gynecologists (ACOG)  ECKERT,  Linda O, MD, FACOG
Professor, Department of Obstetrics & Gynecology
Adjunct Professor, Department of Global Health
University of Washington
Seattle, WA

American College of Physicians (ACP)
GOLDMAN, Jason M , MD, FACP
Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca
Raton, Florida
Private Practice
Coral Springs, FL

American Geriatrics Society (AGS)
SCHMADER, Kenneth, MD
Professor of Medicine- Geriatrics Geriatrics
Division Chief  Duke University and Durham VA Medical Centers
Durham, NC

America’s Health Insurance Plans (AHIP)
GLUCKMAN, Robert A, MD, MACP
Chief Medical Officer, Providence Health Plans
Beaverton, OR

American Immunization Registry Association (AIRA)
COYLE, Rebecca, MSEd
Executive Director, AIRA
Washington, DC

American Medical Association (AMA)
FRYHOFER, Sandra Adamson, MD
Adjunct As sociate Professor of Medicine Emory
University School of Medicine  Atlanta, GA

American Nurses Association (ANA)
RITTLE, Charles (Chad), DNP, MPH, RN Assistant
Professor, Nursing Faculty
Chatham University, School of Health Sciences
Pittsburgh, PA

39
 American Osteopathic Association (AOA)
GROGG, Stanley E, DO
Associate Dean/Professor of Pediatrics
Oklahoma Sta te University -Center for Health Sciences
Tulsa, OK

American Pharmacists Association (APhA)
HOGUE, Michael D., PharmD, FAPhA, FNAP
Dean and Professor of Loma Linda University School of Pharmacy
Director, Center for Interprofessional Education & Practice
Loma Linda, CA
 Association of Immunization Managers (AIM)
HOWELL, Molly, MPH   Immunization Program Manager
North Dakota Department of Health
Bismarck, ND

Association for Prevention Teaching and Research (APTR)
ZIMMERMAN, Richard, MD, MPH
Professor
University of Pittsburgh School of Medicine
Department of Family Medicine and Clinical Epidemiology
Pittsburgh, PA

Association of State and Territorial Health Officials (ASTHO)
SHAH, Nirav D, MD, JD
Director
Maine Center for Disease Control and Prevention
Augusta, ME

Biotechnology Industry Organization (BIO)
ARTHUR, Phyllis A, MBA
Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy
Washington, DC

Council of State and Territorial Epidemiologists (CSTE)
HAHN, Christine, MD
State Epidemiologist
Office of Epidemiology, Food Protection and Immunization Idaho
Department of Health and Welfare
Boise, ID

Council of State and Territorial Epidemiologists (CSTE) (alternate)
LETT, Susan, MD, MPH
Medical Director, Immunization Program
Division of Epidemiology and Immunization
Massachusetts Department of Public Health
Boston, MA

40
 Canadian National Advisory Committee on Immunization (NACI)
DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM
Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia
Associate Professor, Dalla Lana School of Public Health, University of Toronto
Chair, National Advisory Committee on Immunization
Halifax, Nova Scotia

Infectious Diseases Society of America (IDSA)
BAKER, Carol J., MD
Professor of Pediat rics
Molecular Virology and Microbiology
Baylor College of Medicine
Houston, TX

International Society for Travel Medicine (ISTM)
BARNETT, Elizabeth D, MD Professor of
Pediatrics
Boston University School of Medicine
Boston, MA

National Association of County and City Health Officials (NACCHO)
ZAHN, Matthew, MD
Medical Director, Epidemiology
Orange County Health Care Agency
Santa Ana, CA

National Association of County and City Health Officials (NACCHO) (alternate)
DUCHIN, Jeffrey, MD
Health Officer and Chief, Communicable Disease
Epidemiology and Immunization Section
Public Health -  Seattle and King County
Professor in Medicine
Divis ion of Allergy and Infectious Diseases
University of Washington School of Medicine and School of Public Health
Seattle, WA

National Association of Pediatric Nurse Practitioners (NAPNAP)
STINCHFIELD, Patricia A, RN, MS, CPNP
Director
Infectious Disease/Immunology/Infection Control
Children's Hospitals and Clinics of Minnesota
St. Paul, MN

National Foundation for Infectious Diseases (NFID)
SCHAFFNER, William, MD  Chairman, Department  of Preventive Medicine
Vanderbilt University School of Medicine
Nashville, TN

41
 National Foundation for Infectious Diseases (NFID) (alternate)
DALTON, Marla, PE, CAE
Executive Director & CEO
National Foundation for Infectious Diseases (NFID)
Bethesda, MD

National Medical Association (NMA)
WHITLEY -WILLIAMS, Patricia, MD Professor a nd Chair
University of Medicine and Dentistry of New Jersey Robert Wood
Johnson Medical School
New Brunswick, NJ

Pediatric Infectious Diseases Society (PIDS)
O’LEARY, Sean, MD, MPH
Associate Professor of Pediatrics
Pediatric Infectious Diseases
General Academic Pediatrics
Children’s Hospital Colorado
University of Colorado School of Medicine

Pediatric Infectious Diseases Society (PIDS) (alternate)
SAW YER, Mark H, MD
Professor of Clinical Pediatrics
University of California, San Diego School of Medicine
San Diego, CA

Pharmaceutical Research and Manufacturers of America (PhRMA)
ROBERTSON, Corey, MD, MPH
Senior Director, US Medical, Sanofi Pasteur
Swiftwater, PA

Society for Adolescent Health and Medicine (SAHM)  MIDDLEMAN, Amy B, MD, MSEd, MPH
Professor of Pediatrics
Chief, Section of Adolescent Medicine
University of Oklahoma Health Sciences Cente r
Oklahoma City, OK

Society for Healthcare Epidemiology of America (SHEA)
DREES, Marci, MD, MS
Chief Infection Prevention Officer & Hospital Epidemiologist
ChristianaCare
Wilmington, DE
Associate Professor of Medicine
Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA

42

ACRONYMS USED IN THIS DOCUMENT

Acronym  Extension
AAFP  American Academy of Family Physicians
AAP American Academy of Pediatrics
ACHA  American College Health Association
ACIP  Advisory Committee on Immunization Practices
ACOG  American College of Obstetricians and Gynecologists
ACP American College of Physicians
AE Adverse Event
AHIP  America’s Health Insurance Plans
AI/AN  American Indian/Alaskan Native
AIM Association of Immunization Managers
AIRA  American Immunization Registry Association
AMA  American Medical Association
AOA  American Osteopathic Association
APhA  American Pharmacists Association
AR Adverse Reaction
ARI Acute Respiratory Illness
ASTHO  Association of State and Territorial Health Officers
BEST  Biologics Effectiveness and Safety System
BLA Biologics License Application
CBO  Community -Based Organizations
CDC  Centers for Disease Control and Prevention
CHIP  Children’s Health Insurance Program
CISA  Clinical Immunization Safety Assessment
CMS  Center for Medicare and Medicaid Services
COI Conflict of Interest
CSTE  Council of State and Territorial Epidemiologists
DFO  Designated Federal Official
DoD Department of Defense
DSMB  Data Safety Monitoring Board
DUA  Data Use Agreement
DVA Department of Veterans Affairs
ED Emergency Department
EHR  Electronic Health Record
ET Eastern Time
EtR Evidence to Recommendation
EUA Emergency Use Authorization
FDA Food and Drug Administration
FQHC  Federally Qualified Health Center
GBS  Guillain -Barré Syndrome
GMR  Geometric Mean Ratio
GMT  Geometric Mean Titers
GRADE  Grading of Recommendation Assessment, Development and Evaluation
HCP  Healthcare Personnel / Providers
HHS  (Department of) Health and Human Services
43
 IDSA  Infectious Disease Society of America
IHS  Indian Health Service
IIS Immunization Information System
MMWR  Morbidity and Mortality Weekly Report
NACCHO  National Association of County and City Health Officials
NACI  National Advisory Committee on Immunization Canada
NAPNAP  National Association of Pediatric Nurse Practitioners
NCEZID  National Center for Emerging and Zoonotic Infectious Diseases
NCHS  National Center of Health Statistics
NCIRD  National Center for Immunization and Respiratory Diseases
NFID  National Foundation for Infectious Diseases
NIAID  National Institute of Allergy and Infectious Diseases
NIH National Institutes of Health
NMA  National Medical Association
NP Nasopharyngeal
NVAC  National Vaccine Advisory Committee
NVPO  National Vaccine Program Office
NVSN  New Vaccine Surveillance Network
OIDP  Office of Infectious Disease and HIV/AIDS Policy
PCP Primary Care Provider/Practitioner
PCR  Polymerase Chain Reaction
PHAC  Public Health Agency Canada
PHE Public Health Emergency
PICO  Population, Intervention, Comparison, Outcomes
PIDS  Pediatric Infectious Disease Society
RCA  Rapid Cycle Analysis
RCT Randomized Controlled Trial
SAE Serious Adverse Event
SAHM  Society for Adolescent Health and Medicine
SHEA  Society for Healthcare Epidemiology of America
SME  Subject Matter Expert
SVI Social Vulnerability Index
UK  United Kingdom
US United States
USG  United States Government
VAERS  Vaccine Adverse Event Reporting System
VE Vaccine Efficacy
VE Vaccine Effectiveness
VFA Vaccines for Adults
VFC Vaccines For Children
VRBPAC Vaccines and Related Biological Products Advisory Committee
VSD Vaccine Safety Datalink
WG Work Group
WHO  World Health Organization

Summary: MEETING OF THE ADVISORY  COMMITTEE ON IMMUNIZATION  PRACTICES (ACIP)     APRIL 19 , 2023  MEETING SUMMARY     CONTENTS   WEDNESDAY: APRIL 19, 2023 .................................................................................................................... 2   WELCOME AND INTRODUCTIONS  ...................................................................................... 2   Call to Order/Roll Call…