06 COVID Roper 508

Evidence to Recommendations Framework:
Additional Doses of 2024– 2025 COVID -19 Vaccine in Older Adults and
People with Moderate or Severe Immunocompromise
Ms. Lauren Roper, MPH
COVID -19 ACIP Work Group co -lead
Advisory Committee on Immunization Practices Meeting
October 23, 2024National Center for Immunization and Respiratory Diseases

•On June 27, 2024, ACIP voted to recommend 2024 –2025 COVID -19
vaccines for everyone ages 6 months and older
•On August 22, 2024, FDA approved and authorized 2024 –2025 Pfizer -
BioNTech and Moderna COVID -19 vaccines* for people ages 6 months and
older
•On August 30, 2024, FDA authorized 2024 –2025 Novavax COVID -19
vaccine** for people aged 12 years and olderACIP recommendations for COVID -19 vaccines
FDA: Food and Drug Administration
* Omicron JN.1 lineage, KP .2 strain** Omicron JN.1 lineage, JN.1 strain2
In addition to previously recommended 2024– 2025 vaccination:
•Should a second dose* of 2024– 2025 COVID -19 vaccine be recommended for adults
ages 65 years and older?
•Should a second dose** of 2024– 2025 COVID -19 vaccine be recommended for
people ages 6 months and older who are moderately or severely
immunocompromised?
•Should additional doses (i.e., 3 or more) of 2024– 2025 COVID -19 vaccine be
recommended for people ages 6 months and older who are moderately or severely
immunocompromised under shared clinical decision -making ?Evidence to Recommendations ( EtR) Framework
Policy Questions
*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age -appropriate 2024 -
2025 COVID -19vaccine 6 months (minimum interval 2 months) after second dose.
**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024 –2025 vaccine are recommended, and depending on vaccination
history more may be needed. This additional 2024– 2025 vaccine dose is recommended 6 months (minimum interval 2 months) after com pletion of initial
vaccination series.3
Sept – Nov
2021 COVID -19
vaccine
booster doses
recommended
for persons
ages ≥18 years
May 2022 Additional
COVID -19 vaccine
booster dose
recommended for
persons ages ≥50
years
Sept – Oct
2022 Bivalent
COVID -19
vaccine dose
recommended
for persons
ages ≥5 years
April
2023 Optional additional
bivalent COVID -19
vaccine dose
recommended for
persons ages ≥65
years (under SCDM)
Sept
20232023– 2024
COVID -19 vaccine
doses
recommended
for persons ages
≥6 monthsAdditional 2023 –
2024 COVID -19
vaccine dose
recommended for
persons ages ≥65
years2024– 2025
COVID -19
vaccine doses
recommended
for persons ages
≥6 months
Feb 2024 June 2024 Older adults: timeline of additional COVID -19 vaccine dose
recommendations
SCDM: Shared clinical decision -making 4
•2024– 2025 COVID -19 vaccine dose is recommended at least 2 months after receipt of the
last COVID -19 vaccine dose
•mRNA COVID -19 vaccines authorized or approved for ages 6 months and older and
Novavax COVID -19 vaccine authorized for ages 12 years and older
•People who are previously unvaccinated for COVID -19 and are receiving Novavax should
complete a 2 -dose initial seriesCurrent  recommendations for people ages 5 years and older
Doses recommended:
•1 dose of 2024– 2025 COVID -19 vaccine
5
People with moderate or severe immunocompromise: ACIP
recommendations for additional COVID -19 vaccine doses
Oct/Nov 2021 Additional COVID -19 vaccine
booster dose recommended
for people with moderate or
severe immunocompromise
April 2022 Optional 2nd booster
dose of mRNA ≥ 4
months after 1st booster
(under SCDM)
April 2023 Optional additional bivalent mRNA dose
for people with immunocompromise who
have already received a bivalent mRNA
dose, at least 2 months after initial
bivalent mRNA dose (under SCDM)
Additional bivalent mRNA doses as
needed, at 2-month intervals at the
discretion of the healthcare provider
(under SCDM)
https://www.sciencedirect.com/science/article/pii/S0264410X23014664?via%3Dihub
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023- 04-19/06- COVID -Oliver -508.pdf
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023- 04-19/07- COVID -Twentyman -508.pdf  SCDM: Shared clinical decision -making
6
Current  recommendations for people ages 6 months and older
who are moderately or severely immunocompromised
Doses recommended:
Initial COVID -19 vaccine series*
At least 1 2024– 2025 COVID -19 vaccine dose
May receive 1 additional 2024 –2025 COVID -19
vaccine dose with option for further additional
doses of 2024– 2025 COVID -19 vaccine**
*Series of 3 homologous mRNA COVID -19 vaccine doses or 2 Novavax COVID -19 vaccine doses (if ages 12 years and older); includes r evaccination after
hematopoietic cell transplant and CAR -T-cell, or B -cell- depleting therapies.
**Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare provider and personal pr eference and
circumstances. Further additional doses should be administered at least 2 months after the last 2024 -2025 COVID -19 vaccine dose.
For more information, see https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim- considerations -us.html#immunocompromised .
7
In addition to previously recommended 2024– 2025 vaccination:
•Should a second dose* of 2024– 2025 COVID -19 vaccine be recommended
for adults ages 65 years and older?
•Should a second dose** of 2024– 2025 COVID -19 vaccine be recommended
for people ages 6 months and older who are moderately or severely
immunocompromised?
•Should additional doses (i.e., 3 or more) of 2024– 2025 COVID -19 vaccine be
recommended for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision- making ?Evidence to Recommendations ( EtR) Framework
Policy Questions
*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age -
appropriate 2024 -2025 COVID -19vaccine 6 months (minimum interval 2 months) after second dose.
**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024 –2025 vaccine are recommended, and depending on
vaccination history more may be needed. This additional 2024– 2025 vaccine dose is recommended 6 months (minimum interval 2 months) after
completion of initial vaccination series.8
EtR Domain:
Public Health Problem
9
COVID -19 circulates year -round.
Reported was last updated on October 16, 2024.
All results presented from nucleic acid amplification tests which represent >90% of the diagnostic tests reported to NREVSS. The last three weeks of data may be less complete. NREVSS is an abbreviation for the
National Respiratory and Enteric Virus Surveillance System. For more information on NREVSS, please visit www.cdc.gov/surveillance/nrevss .
SARS -COV-2: Severe acute respiratory syndromic coronavirus type 2
Flu: Influenza viruses types are combined but reported by type and subtype depending on the testing capabilities of each cont ributing laboratory.
RSV: Respiratory Syncytial Virus. Types A and B are reported but not shown separately in this report.
https://www.cdc.gov/nrevss/php/dashboard/index.html
National weekly percent positive for SARS -COV -2, RSV and influenza reported to NREVSS, August 27, 2022 through October 12, 2024
10
COVID -19 has consistently peaked in winter and late -
summer.
National Respiratory and Enteric Virus Surveillance System (NREVSS)11
COVID- 19–associated hospitalizations also peaked in
winter and late -summer.
NREVSS: National Respiratory and Enteric Virus Surveillance System12
Factors that could impact COVID -19 periodicity
Factor Potential contributors
Host •Natural infection (reinfection)
•Timing of vaccination
•Waning immunity
Virus •Variant emergence and displacement
•Variant characteristics (e.g., immune escape,  transmissibility)
Environment •Temperature
•Relative humidity
•UV radiation
Behavior
  •Travel and mobility
•Time spent indoors
•School and daycare schedules
•Holidays and large gatherings
13
Public Health Problem: older adults
14
Adults ages ≥65 years comprise 2/3 of all COVID- 19–
associated hospitalizations among adults.
during this same period of October 2023 through August 2024, children and adolescents ages 17 years and younger comprised 4% of all COVID -19-associated hospitalizations.0%10%20%30%40%50%60%70%80%90%100%Percent of adults hospitalized with COVID -19
Surveillance week end datePercent of weekly COVID -19–associated hospitalizations, by age group —
COVID -NET, March 2020– August 2024
18–49 years 50–64 years 65–74 years ≥75 years≥75 years=50%
≥65 years=70%
15
COVID -19–associated deaths per 100,000 population by age
group, United States, January 1, 2023 – September 30, 2024
Source: Provisional death data from CDC’s National Center for Health Statistics (NCHS), National Vital Statistics System (NVSS).
Provisional data are non -final counts of deaths based on reported mortality data in NVSS. Deaths include those with COVID -19, coded as ICD –10 code U07.1, as an
underlying or contributing cause of death on the death certificate. Death data are displayed by date of death (event).
https://covid.cdc.gov/covid- data -tracker/#demographicsovertime Accessed October 22, 2024.
16
Seroprevalence definition: The percentage of people with antibodies against a virus in their blood is known as seroprevalence .
Methodology available at https://covid.cdc.gov/covid- data -tracker/#nationwide -blood -donor -seroprevalence- 2022
https://www.cdc.gov/mmwr/volumes/72/wr/mm7222a3.htm  Weighted U.S. SARS -CoV-2 seroprevalence by vaccine and
infection history and age, based on blood donations
24149
71520
687070
110
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%65 years and older50 to 64 years30 to 49 yearsOctober 1st – December 31, 2023
Vaccination-only seroprevalence Infection-only seroprevalence Hybrid immunity Neither past infection nor vaccination
17
Pool of naïve T cells diminishes with age
Immunosenescence  refers to  age-associated immune decline that may result in an inefficient immune response to
novel antigens and an inability to develop proper immunity against infections and upon vaccination.
de Candia P, Prattichizzo  F, Garavelli S, Matarese G. T Cells: Warriors of SARS -CoV- 2 Infection. Trends Immunol. 2021 Jan;42(1):18- 30. doi: 10.1016/j.it.2020.11.002. Epub 2020 Nov
13. PMID: 33277181; PMCID: PMC766435118
Insufficient pools of naïve T
cells impacts ability to
generate:
•Neutralizing antibody responses
•Cytotoxic T cellsAdaptive immunity includes cellular and humoral
responses
Rey, Gertrud.  T Cell Responses to Coronavirus Infection are Complicated. https://www.virology.ws/2020/11/05/t -cell-responses -to-coronavirus -infection -are-complicated/19
Public health problem: People with
moderate or severe immunocompromise
20
About 1 in 6 (15.6%) persons hospitalized with COVID -19
have an immunocompromising condition.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission.16314 162215
0%10%20%30%40%50%60%70%80%90%100%
Total 0–4 5–17 18–49 50–64 ≥65Percent of persons hospitalized with COV I D -19
A ge groupImmunocompromising condition among persons with COVID -19–associated hospitalization, by age group —
COVID -NET, July 2023 –May 2024
Immunocompromising condition No immunocompromising condition
21
The most common immunocompromising conditions
among persons hospitalized with COVID -19 include:
* Within the 12 months before admission
** Current/in treatment or diagnosed in the 12 months before admission
***  Within 2 weeks before admission. Does not include inhaled, intranasal steroids or intramuscular or intra -articular injectio n of steroids.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission.46
34
26
22
9
6
5
4
3
2
1
0.8
0.1
10 5 10 15 20 25 30 35 40 45 50
* Immunosuppressive therapy
** Solid organ malignancy
*** Steroid therapy
** Metastatic cancer
Solid organ transplant
** Lymphoma/Hodgkins/Non-Hodgkins
HIV infection
** Leukemia
Bone marrow transplant
Immunoglobulin deficiency
** Multiple myeloma
AIDS or CD4 count <200
Graft vs. host disease
Other immunocompromising conditionsPercent of persons hospitalized with C OV I D -19Prevalence of immunocompromising conditions among adults hospitalized with COVID -19 with immunocompromised status —
COVID -NET, July 2023– May 2024
Prevalence of conditions among
the 16% of hospitalized persons
with immunocompromising
conditions
22
Risk for severe outcomes during COVID -19–associated
hospitalization among adults varies by immunocompromising
condition status.
Data are limited to hospitalizations where COVID -19 is a likely primary reason for admission.27
18
15 15
6
4
051015202530
ICU admission Invasive mechanical ventilation In-hospital deathPercent of persons hospitalized with C OV I D -19Prevalence of outcomes and interventions among adults ages ≥18 years hospitalized with COVID -19,
by immunocompromising condition status —  COVID -NET, July 2023– May 2024
Immunocompromising condition No immunocompromising conditionSample size with I.C. condition = 512
23
Domain Equity Question:
Does the problem impact all populations equally?
24
Age-adjusted cumulative COVID- 19 hospitalizations per
100,000 population by race and ethnicity — COVID -NET,
October 2023 – September 2024
A/PI: Asian or Pacific Islander; AI/AN: American Indian or Alaska Native
CDC COVID Data Tracker. https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network . Accessed October 15, 2024Equity
 25
Number of chronic conditions by age among Asian,
Black, Latino/Hispanic, and White adults in the National
Health Interview Survey, 1999 to 2018
Caraballo C, Herrin J, Mahajan S, et al. Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the  United States, 1999 -2018. Am J Med . 2022;135(9):1083-
1092.e14. doi:10.1016/j.amjmed.2022.04.010 Equity 26
Difference in prevalence of multiple chronic conditions
by age and race/ethnicity, National Health Interview
Survey, 1999 to 2018
Caraballo C, Herrin J, Mahajan S, et al. Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the  United States, 1999 -2018. Am J Med .
2022;135(9):1083- 1092.e14. doi:10.1016/j.amjmed.2022.04.010Equity 27
Prevalence of Self- Reported Status of
Immunosuppression Among US Adults, NHIS 2021
7
576
48
4
02468101214161820
Overall Hispanic White, non-
HispanicBlack, non-
HispanicAsian, non-
HispanicAI/AN, non-
HispanicOther, non-
HispanicWeighted Prevalence by Race and Ethnicity, per 100 US population
95% Confidence interval represented by error bars
Other: NHIS includes a choice for “some other race” in the questionnaire for respondents who do not identify with the racial and ethnic categories provided
https://jamanetwork.com/journals/jama/fullarticle/2815274  Equity 28
Prevalence of Self- Reported Status of
Immunosuppression Among US Adults, NHIS 2021
58
02468101214161820
Male FemaleWeighted Prevalence by Sex, per 100
US population
95% Confidence interval represented by error bars
https://jamanetwork.com/journals/jama/fullarticle/2815274  7
3
02468101214161820
Insured UninsuredWeighted Prevalence by Health
Insurance Status, per 100 US population
Equity 29
•SARS -CoV-2 continues to circulate year- round with peaks occurring in the winter and late
summer
•Adults ≥65 years have the highest rates of hospitalizations due to COVID -19 compared to other
age groups, though hospitalizations have decreased over time
•Adults ≥65 years also have the highest rates of death due to COVID -19
•Adults ≥65 years have higher rates of vaccination -only seroprevalence compared to younger ages
•Age-adjusted COVID -19 associated hospitalizations are highest among American Indian/Alaska
Native non -Hispanic persons followed by Black non -Hispanic persons and are lowest among Asian
and Pacific Islander non -Hispanic persons
•The number of chronic conditions increases with increasing age, and are higher among Black non -
Hispanic persons than other racial and ethnic groups
-By age 50, approximately 25% of Black non -Hispanic persons have 2 or more chronic conditions, and by
age 65, approximately 50% have 2 or more chronic conditionsSummary
Public Health Problem –  Adults ages ≥65 years
30
•About 1 in 6 people hospitalized with COVID- 19 have an immunocompromising
condition
•Risk for severe outcomes during COVID -19–associated hospitalization among adults
varies by immunocompromising condition status.
•Prevalence of self -reported immunosuppression status differs by race and ethnicity,
sex, and health insurance statusSummary
Public Health Problem –  People with moderate or
severe immunocompromise
31
Public Health Problem
Work Group Interpretation
Is COVID -19 disease among adults ages ≥65 years of public health
importance?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
Is COVID -19 disease among persons with moderate or severe
immunocompromise of public health importance?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
32
EtR Domain:
Benefits and Harms
33
COVID -19 vaccine effectiveness (VE) against hospitalization  wanes over time,
but is more sustained against critical illness , though some waning is evident
Data from VISION and IVY showing VE by vaccine formulation of most recent dose.
-20020406080100
7-59 or 14-59 60-119 120-179 180-239* 240-299* 300-364* 365+Vaccine effectiveness (%)
Days since last dose
Recipients of bivalent and 2023 –2024 doses included in this analysis received a single dose of the most recent formulation.
Sources: DeCuir, et al., MMWR 2023/  Lin k-Gelles, ACIP Slides, April 20, 2022 ; CDC unpublished data updated from Link -Gelles, ACIP Slides, June 23, 2023; CDC unpublished data updated from: Link -Gelles, ACIP Slides, June 27, 2024
* For original monovalent doses, VE for hospitalization was for 180 -364 days from last dose combined. For 2023– 2024 doses, VE fo r hospitalization was for ≥180 days combined, with a median of 228 days (IQR: 202- 259).Hosp italization Critical illness
Original monovalent (adults aged 50+; ref: unvaccinated)
Bivalent (adults aged 18+; ref: unvaccinated)
2023– 2024 (adults aged 18+; ref: no 2023– 2024 dose)  Benefits
34
Microsimulation modeling study compares frequency
of COVID- 19 vaccination by risk group
Park, H.J., Gonsalves, G.S., Tan, S.T. et al. Comparing frequency of booster vaccination to prevent
severe COVID -19 by risk group in the United States. Nat Commun 15, 1883 (2024).
https://doi.org/10.1038/s41467- 024- 45549- 9 Step 1 : Assign to risk group
•Age group: 18-49, 50- 64, 65- 74, 75+ years
•Immune status: immunocompetent,
immunocompromised (mild, moderate/severe)Step 3 : Calibrate model to data
•Epidemiologic data: COVID -19 severe incidence, seroprevalence
•Calibrated to ~September 2022
Computer
simulation
Step 2 : Simulate vaccine -induced or hybrid protection
•Vaccine: number doses, timing of last dose
•Prior infection: yes/no, timing of last infection
•Vaccine/hybrid protection data: level of protection and waning curves Step 4 : Run simulation of different vaccine strategies
•Vaccine strategies: One -time (1 dose); Annual (2 doses), Semi -annual (4
doses); Simulate over 2 -years
•Simulate person- level waning of protection and COVID -19 at each time step
(static infection model)
•Primary study outcome: Absolute annual risk of severe COVID -19
3 Month
06 1
Benefits35
Annual and semiannual COVID -19 vaccine doses likely to have largest benefit in
people ages ≥65 years and people who are immunocompromised
Absolute annual risk of
COVID -19 hospitalization*
(cases per 100,000;
uncertainty interval)Annual risk reduction of COVID -19
hospitalization* NNT to avert one
COVID -19
hospitalization* Absolute risk (cases
per 100,000)Relative risk
(%)
One -time booster
18-49 years 98 (85 - 125) -- -- --
50-64 years 199 (185 - 238) -- -- --
65-74 years 524 (499 -  562) -- -- --
75+ years 1,398 (1,332 - 1,501) -- -- --
Immunocompromised (mild) 1,290 (1,205 –  1,403) -- -- --
Immunocompromised (moderate/severe) 1,367 (1,266- 1,503) -- -- --
Annual booster
18-49 years 84 (74 - 106) 14 14% 3,534
50-64 years 171 (159 -  202) 28 14% 1,806
65-74 years 446 (425 -  475) 78 15% 642
75+ years 1,198 (1,144 - 1,272) 199 14% 251
Immunocompromised (mild) 1,180 (1,088 - 1,316) 110 9% 456
Immunocompromised (moderate/severe) 1,183 (1,091- 1,307) 184 13% 273
Semiannual booster (every 6 months)
18-49 years 72 (64 - 90) 26 27% 1,916
50-64 years 147 (136 -  171) 52 26% 968
65-74 years 382 (365- 404) 142 27% 353
75+ years 1,030 (988 - 1,088) 368 26% 136
Immunocompromised (mild) 1,095 (987 - 1,255) 195 15% 257
Immunocompromised (moderate/severe) 1,057 (966- 1,183) 310 23% 162
NNT: number of persons needed to follow vaccine strategy to prevent one severe COVID -19 case over 2- year
period
*Hospitalization for COVID -19 defined as severe COVID -19 in publication
Note: incidence of severe COVID -19 is currently lower than when this model was calibrated, so measures of
absolute risk are likely an overestimate and NNTs are likely an underestimate based on current epidemiologyPark, H.J., Gonsalves, G.S., Tan, S.T. et al. Comparing frequency of booster
vaccination to prevent severe COVID -19 by risk group in the United States. Nat
Commun 15, 1883 (2024). https://doi.org/10.1038/s41467- 024- 45549- 9 Benefits36
•2023– 2024 COVID -19 vaccination provided increased protection against COVID -19 associated
ED/UC visits and hospitalizations compared to no 2023 –2024 vaccine dose.
-Protection waned to 0 against COVID -19-associated ED/UC visits and hospitalization by ~4 -6 months
•Waning patterns of 2023 –2024 COVID -19 vaccines appeared similar to previous COVID -19 vaccine
formulations; most durable protections appeared to be for critical illness
-VE against critical illness remained above 40% at 5 months after vaccination among those ≥65 years
•As with previous COVID -19 vaccine formulations, effectiveness was similar across age groups
•Data from prior seasons shows that an additional dose appeared to provide some additional
protection
•Updated COVID -19 vaccination helped provide protection against COVID -19–related
thromboembolic events (ischemic stroke, venous thromboembolism, and myocardial infarction) in adults 65 years and older.
•Based on modeling data, annual and semiannual COVID -19 vaccine doses likely to have largest
benefit in people ages ≥65 years and people who are immunocompromisedSummary of Benefits: Adults ≥65 years
BenefitsED/UC: Emergency Department/Urgent Care 37
•COVID -19 vaccines provided protection for both persons with and without immunocompromise.
•Patterns of COVID -19 VE in immunocompromised were different season -to-season, with generally
lower VE compared to non -immunocompromised, but with inconsistent waning patterns
-During 2023– 2024, VE against hospitalization in people with immunocompromising conditions waned to 0 by
~4-6 months.
•This inconsistency in waning patterns is likely multifactorial, including:
-Heterogeneity among those classified as immunocompromised
-Variation in underlying immunity and response to prior infection
-Differing health behaviors (e.g., masking, social distancing) over time and by immunocompromise status
•Based on modeling data, annual and semiannual COVID -19 vaccine doses likely to have largest
benefit in people ages ≥65 years and people who are immunocompromisedSummary of Benefits: People with moderate or severe
immunocompromise
Benefits38
Reactogenicity and health impacts of COVID -19 vaccine were
reported less frequently in those ≥65 years vs younger age
groups
Presented to ACIP on Feb 24, 2023
 HarmsV-safe:  reactions and health impacts reported by participants aged ≥5 years at
least once in days 0 -7 after bivalent booster dose, by age group, 2022 –2023
39
Among persons aged ≥50 years, injection site and systemic
reactions were reported less frequently to v -safe in subsequent
dosing following the initial vaccination series
https://www.cdc.gov/mmwr/volumes/71/wr/mm7130a4.htm?s_cid=mm7130a4_w
 HarmsV-safe:  reactions and health impacts reported by participants aged ≥50 years at
least once in days 0 -7 after doses 1 – 4, through July 2022
40
Local and systemic reactions were less frequently reported to
v-safe after mRNA booster (dose 4) than after the 3- dose initial
series
https://www.cdc.gov/mmwr/volumes/71/wr/mm7128a3.htm?s_cid=mm7128a3_w
 HarmsV-safe: reactions and health impacts reported by participants aged ≥12 years
with  presumed immunocompromise status  at least once in days 0 -7 after
doses 1 –4, through March 2022
41
VSD signal for ischemic stroke in 2022 –2023
•Vaccine Safety Datalink (VSD) Rapid Cycle Analysis (RCA) is weekly sequential active
surveillance
•Ischemic stroke was a prespecified outcome monitored by RCA
-No signal following primary series doses (2020– 2021)
-No signal following first booster (3rd) dose (2021– 2022)
-Signal following first bivalent vaccine dose (2022– 2023)
•For Pfizer -BioNTech COVID- 19 vaccine, bivalent among people aged ≥65 years in the 1– 21
days risk interval following vaccination compared to days 22– 42
•Presented to ACIP on February 24, 2023
•Follow -up ACIP presentations in April 2023 and October 2023
–Reviewed findings from 7 studies done in 4 countries
–No clear and consistent evidence of a safety problem
https://www.fda.gov/vaccines -blood -biologics/safety -availability -biologics/cdc -and- fda-identify -preliminary -covid -19-vaccine -safety-signal -persons -aged -65-years -and- older Harms42
It is currently unclear if the VSD signal for ischemic stroke in
2023– 2024 represents a true increased risk following COVID -19
vaccination
•Vaccine Safety Datalink (VSD) Rapid Cycle Analysis (RCA) for 2023– 2024 identified
statistical signals for ischemic stroke following:
-Moderna (aged ≥65 years)
-Pfizer (aged 50 -64 years)
•Presented to ACIP on June 27, 2024
•CDC and FDA are continuing to evaluate this outcome
https://www.cdc.gov/acip/meetings/presentation- slides -june -26-28-2024.html  Harms43
•VSD had not identified any signals for GBS with previous mRNA COVID- 19 vaccine formulations (i.e.,
original primary series, original booster, or 2022– 2023 bivalent)
•The increased rate ratio observed for Pfizer COVID -19 vaccine during the 2023 –2024 season may or
may not represent a true risk
-A large  number of analyses may find some associations by chance alone
-Surveillance  analyses may have residual confounding
•If there is a true risk, then t he estimated excess GBS cases of 4.1 per million doses is similar to
previous estimates for other vaccines for adults
-Influenza:  1 -  2 cases per million doses1
-Recombinant Zoster Vaccine:  3 - 6 cases per million doses2
•There were insufficient doses of Moderna or Novavax vaccines administered in the VSD to assess
the rate of GBS with those vaccinesVSD signal for Guillain -Barré syndrome (GBS) in 2023–
2024
1 Perez -Vilar  S, et al. Guillain- Barré Syndrome After High -Dose Influenza Vaccine Administration in the United States, 2018 -2019 Season . J Infect Dis. 2021 Feb 13;223(3):416 -425.
2 Janusz CB, et al. Projected risks and health benefits of vaccination against herpes zoster and related complications in US adults . Human Vaccines & Immunotherapeutics , 18(5), 2022. Harms44
Pending information relevant to VSD signals for
ischemic stroke and GBS
•FDA’s 2023 –2024 COVID-19 vaccine safety surveillance using commercial
health plans and Medicare claims databases results are expected later this
year, which will provide additional information about ischemic stroke, GBS, and other outcomes
•A follow -up VSD study is in progress to further examine the risk of ischemic
stroke after mRNA COVID-19 vaccines during 2022 –2023 and 2023 –2024
VSD: Vaccine Safety Datalink; GBS: Guillain- Barré syndrome Harms45
Summary: COVID -19 vaccine safety
•Robust safety surveillance over 3 years of COVID -19 vaccine use demonstrated that
serious adverse events have been rare.
-Anaphylactic reactions have been rarely reported following receipt of COVID- 19 vaccines.
-Rare risk of myocarditis and pericarditis, however this is predominately in males ages 12- 39 years.
•There has been no increased risk observed in adults aged ≥65 years
•Whether the risk might be different in immunocompromised people is unknown
•COVID -19 vaccine doses continue to be reactogenic
-The rate of local and systemic reactions reported to V -safe was lower with additional doses than
after the initial series
-Most vaccine recipients have mild reactions, but during 2023– 2024, at least 10% reported health
impact events during the 7 days post -vaccination, such as being unable to complete daily activities
-Overall, symptoms less frequent and severe among older adults compared with adolescents and
younger adults.
Harms46
Domain Equity Question:
Are the desirable and undesirable anticipated effects demonstrated across
all populations equally?
47
Are the desirable and undesirable anticipated effects
demonstrated across all populations equally?
•There is no evidence to suggest that COVID- 19 vaccine effectiveness varies
substantially by race/ethnicity.1,2
-Differences in vaccine hesitancy/uptake, crowding, access to care, and prior infection could
impact vaccine effectiveness and these factors may also differ by race/ethnicity.
•There is no evidence to suggest that COVID- 19 vaccine safety profiles vary by
race/ethnicity, however risk has been shown to differ by age and sex.
-Risk for myocarditis is highest in adolescent and young adult males.
•Benefits and harms for the U.S. population are best assessed when clinical trial and
study populations are optimally representative of the U.S. population.
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9619452/
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9763212/  Equity 48
Benefits and Harms
How substantial are the desirable anticipated effects of a second dose of
2024 –2025 COVID -19 vaccine in adults ages ≥65 years?
• How substantial are the anticipated effects for each main outcome for
which there is a desirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
49
Benefits and Harms
How substantial are the undesirable anticipated effects of a second dose of
2024 –2025 COVID -19 vaccine in adults ages ≥65 years?
• How substantial are the anticipated effects for each main outcome for
which there is an undesirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
Majority Opinion Minority Opinion 50
Benefits and Harms
Do the desirable effects of a second dose of 2024 –2025 COVID -19 vaccine
outweigh the undesirable effects in adults ages ≥65 years?
• What is the balance between the desirable effects relative to the
undesirable effects?
oFavors intervention (Additional dose of 2024 – 2025 COVID -19 vaccine)
oFavors comparison (No additional dose of 2024 – 2025 COVID -19 vaccine)
oFavors both
oFavors neither
oUnclear
51
Benefits and Harms
How substantial are the desirable anticipated effects of a second dose of
2024 –2025 COVID -19 vaccine in people with moderate or severe
immunocompromise?
• How substantial are the anticipated effects for each main outcome for which there is a desirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
52
Benefits and Harms
How substantial are the undesirable anticipated effects of a second dose of
2024 –2025 COVID -19 vaccine in  people with moderate or severe
immunocompromise?
• How substantial are the anticipated effects for each main outcome for which there is an undesirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
Majority Opinion Minority Opinion 53
Benefits and Harms
Do the desirable effects of a second dose of 2024 –2025 COVID -19 vaccine
outweigh the undesirable effects in people with moderate or severe
immunocompromise?
• What is the balance between the desirable effects relative to the
undesirable effects?
oFavors intervention (second dose of 2024 – 2025 COVID -19 vaccine)
oFavors comparison (no second dose of 2024 – 2025 COVID -19 vaccine)
oFavors both
oFavors neither
oUnclear
54
Benefits and Harms
How substantial are the desirable anticipated effects of additional doses (i.e.,
3 or more) of 2024 –2025 COVID -19 vaccine in people with moderate or
severe immunocompromise?
• How substantial are the anticipated effects for each main outcome for which there is a desirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
55
Benefits and Harms
How substantial are the undesirable anticipated effects of additional doses
(i.e., 3 or more) of 2024 –2025 COVID -19 vaccine in people with moderate or
severe immunocompromise?
• How substantial are the anticipated effects for each main outcome for which there is an undesirable effect?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
56
Benefits and Harms
Do the desirable effects of additional doses (i.e., 3 or more) of 2024 –2025
COVID -19 vaccine outweigh the undesirable effects in people with moderate
or severe immunocompromise?
• What is the balance between the desirable effects relative to the
undesirable effects?
oFavors intervention (Additional doses of 2024 – 2025 COVID -19 vaccine)
oFavors comparison (No additional dose of 2024 – 2025 COVID -19 vaccine)
oFavors both
oFavors neither
oUnclear
57
EtR Domain:
Values
58
Key attitudes and experiences among adults 18 years and older,
July 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
21%49%63%
31%50%63%
38%64%74%
0%10%20%30%40%50%60%70%80%90%100%
Concerned about COVID-19
diseaseConfidence in COVID-19 vaccine
safetyConfidence that COVID-19 vaccine
is somewhat or very important to
protect mePercentCOVID -19 Vaccination Key Attitudes and Experiences by Age
Group Among Adults Age ≥18 Years, NIS -ACM, July 2024
18-49 years 50-64 years 65+ years
The July estimates are based on data collected July 1 –27 2024.
CDC. COVID -19 Vaccination Coverage and Vaccine Confidence Among Adults.
https://www.cdc.gov/covidvaxview/interactive/adults.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/imz -managers/coverage/covidv axview/interactive/adults.html
Accessed October 3, 2024Generally, adults ages 65 years
and older were more concerned about COVID -19
disease and had higher confidence in vaccine safety and vaccine importance; those ages 18 –49 years and 50– 64
years were less concerned and confident.
59
•Limited data exists on concern about COVID -19 disease specifically in
people with moderate or severe immunocompromiseValues: People with moderate or severe
immunocompromise
60
24.7
32.6
25.915.2
19.2
19.915.8
16.4
20.013.0
10.9
8.731.3
20.9
25.5
0 25 50 75 100Three or more dose s
(≥18 years with health
condition,† N=459)Second dose ( ≥65 years &
≥18 years with health
condition,† N=1,263)First dose ( ≥18 years,
N=4,044)
Weighted %Definitely will Probably will Unsure Probably will not Definitely will not
*165 respondents excluded from analysis due to inconsistent answers.
† Health condition includes cancer (excluding basal cell carcinoma and squamous cell carcinoma), solid organ or blood stem cell  transplant, HIV, and immunocompromised state. Intent to receive 2024– 2025 COVID -19 vaccination among
adults ≥18 years
Omnibus Surveys, August 8 –26, 2024 (N=4,044)*
61
Domain Equity Question:
Is there important variability in how patients or populations value the
outcome?
62
Key attitudes and experiences among adults 65 years and older,
July 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
36%67%76%
37%64%72%
45%63%88%
29%51%66%
0%10%20%30%40%50%60%70%80%90%100%
Concerned about COVID-19 disease Confidence in COVID-19 vaccine safety Confidence that COVID-19 vaccine is
somewhat or very important to protect mePercentCOVID -19 Vaccination Key Attitudes and Experiences by Race & Ethnicity
Among Adults Age 65 Years and Older, NIS -ACM, July 2024
Hispanic White, non-Hispanic Black, non-Hispanic Other or multiple races, non-Hispanic
The July estimates are based on data collected July 1 –27 2024.
CDC. COVID -19 Vaccination Coverage and Vaccine Confidence Among Adults.
https://www.cdc.gov/covidvaxview/interactive/adults.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/imz -managers/coverage/covidv axview/interactive/adults.html
Accessed October 3, 2024Equity 63
Values
Criteria 1:
Do adults ages ≥65 years feel that the desirable effects are large relative to
undesirable effects?
• How do adults ages ≥65 years view the balance of desirable versus
undesirable effects?
• Would adults ages ≥65 years feel that the benefits outweigh the harms?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
64
Values
Criteria 2:
Is there important uncertainty about, or variability in, how adults ages ≥65
years  value the main outcomes?
• Is there evidence that the variability is large enough to lead to different
decisions?
oImportant uncertainty or variability
oProbably important uncertainty or variability
oProbably not important uncertainty or variability
oNo important uncertainty or variability
oNo known undesirable outcomes
65
Values
Criteria 1:
Do people with moderate or severe immunocompromise feel that the
desirable effects are large relative to undesirable effects?
• How do immunocompromised persons ≥6 months of age view the balance
of desirable versus undesirable effects?
• Would immunocompromised persons ≥6 months of age feel that the
benefits outweigh the harms?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
66
Values
Criteria 2:
Is there important uncertainty about, or variability in, how persons with
moderate or severe immunocompromise value the main outcomes?
• Is there evidence that the variability is large enough to lead to different
decisions?
oImportant uncertainty or variability
oProbably important uncertainty or variability
oProbably not important uncertainty or variability
oNo important uncertainty or variability
oNo known undesirable outcomes
67
EtR Domain:
Acceptability
68
Percent vaccinated with 2023– 2024 COVID -19 vaccine
National Immunization Survey -Adult COVID Module (NIS -ACM)
https://www.cdc.gov/covidvaxview/weekly -dashboard/adult -vaccination -coverage.html   accessed October 4, 2024
69
COVID -19 vaccination coverage (≥1 dose and ≥2 doses) among
adults 65 years and older, 2023– 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
3.85.77.38.9
0.020.040.060.080.0
9/30/2023
10/7/2023
10/14/2023
10/21/2023
10/28/2023
11/4/2023
11/11/2023
11/18/2023
11/25/2023
12/2/202312/9/2023
12/16/2023
12/23/2023
12/30/2023
1/6/2024
1/13/2024
1/20/2024
1/27/2024
2/3/2024
2/10/2024
2/17/2024
2/24/2024
3/2/20243/9/2024
3/16/20243/23/2024
3/30/2024
4/6/2024
4/13/2024
4/20/2024
4/27/2024
5/4/2024
5/11/20245/18/2024
5/25/2024
6/1/2024
6/8/2024
6/15/20246/22/2024
6/29/2024Vaccination coverage (%)
Week ending date≥1 dose (65+)
≥2 doses (65+)
39.3
70
COVID -19 Vaccination Coverage (≥2 Doses) Among Adults 65 Years
and Older and Adults 18 Years and Older Who Are
Immunocompromised, 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
3.85.77.38.9
2.5 3.34.5 5.4
0.010.020.030.040.0
Mar-24 Apr-24 May-24 Jun-24Vaccination coverage (%)
Data collection month≥2 doses (65+)
≥2 doses (18+ immunocompromised)
71
A healthcare provider
recommendation for COVID -19
vaccine was highest among adults ages ≥65 yearsHealthcare provider recommendation for COVID -19 vaccine, by
age, among adults ages 18 years and older, July 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
22%
18%25%28%
0%5%10%15%20%25%30%35%Healthcare Provider Recommendation for COVID -19 Vaccine
by Age Among Adults Ages 18 years and older,
NIS-ACM, July 2024
Overall 18-49 years 50-64 years ≥65 years
The July estimates are based on data collected July 1 –27 2024.
CDC. COVID -19 Vaccination Coverage and Vaccine Confidence Among Adults.
https://www.cdc.gov/covidvaxview/interactive/adults.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/imz -managers/coverage/covidv axview/interactive/adults.html
Accessed October 4, 202472
A healthcare provider recommendation was higher among adults 65 and older
who had received ≥2 doses of 2023 –2024 COVID -19 vaccine by end of June 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
SVI: Social vulnerability index
*Statistically significant at p<0.05 (referent categories: No health condition, No provider recommendation).7.213.68.79.713.97.710.38.69.38.7
0.0 10.0 20.0 30.0 40.0 50.0 60.0No provider recommendationHealth care provider recommended COVID-19 vaccineDoes not have any disabilityHas a disabilityImmunocompromisedNo health conditionHas health conditionHigh SVIModerate SVILow SVI
W eighted % (95% C I )*
*
73
70% of healthcare provider respondents reported recommending a second
COVID -19 vaccination to eligible patients aged 65 years and older most of the
time or always, October 2024 Survey
N= 1,000, data from University of Iowa/RAND, unpublished survey of physicians, advanced practice providers, pharmacists, and nur ses who spend at least 50% of time providing
outpatient care and have vaccines administered at worksite. October 9 -16 2024. 74
68% of healthcare provider respondents reported recommending a
second COVID -19 vaccination to eligible patients who were
immunocompromised most of the time or always  , October 2024 Survey
N= 1,000,  data from University of Iowa/RAND, unpublished survey of physicians, advanced practice providers, pharmacists, and nurses who spend at least 50% of time providing
outpatient care and have vaccines administered at worksite. October 9 -16 2024. 75
•Feedback was obtained via the WG liaisons from organizations* that focus on older
adults, people with immunocompromise, healthcare providers, and pharmacists
•Prefer age-based recommendations  (universal) over risk -based or shared clinical
decision -making
-Implementation challenges for both risk -based and shared clinical decision -making on top of an
already complicated vaccination schedule
-Shared clinical decision -making recommendations can appear to have lower confidence and are
difficult to communicate
•Frequent changes in vaccine recommendations create confusion
•Most preferred one to two total doses a year
•Reiterate that  self-attestation of being moderately or severely immunocompromised
is permissibleWork Group Professional Organization Liaison Feedback
*Infectious Diseases Society of America, American Geriatrics Society, American Pharmacists Association, Society for Healthcar e Epidemiology of America 76
Domain Equity Question:
Is the intervention equally acceptable across all populations?
77
2023– 2024 COVID -19vaccine ≥2 dose coverage among adults aged ≥65 years varied by race
and ethnicity and urbanicity
National Immunization Survey- Adult COVID Module (NIS -ACM)
21.813.516.29.011.18.112.76.78.311.17.49.09.210.69.18.78.9
0.0 10.0 20.0 30.0 40.0 50.0 60.0AI/ANOther/multiple, non-HispanicNH/OPIHispanicBlack, non-HispanicWhite, non-HispanicAsianRuralSuburbanUrban65-6970-7475-7980+MaleFemaleOverall 65+
W eighted % (95% C I )9.48.48.510.510.78.818.011.17.87.76.88.97.39.38.08.4
0.0 10.0 20.0 30.0 40.0 50.0 60.0Income unknownAbove poverty, >=$75KAbove poverty, <$75KBelow povertyUninsuredInsuredHHS Region 10HHS Region 9HHS Region 8HHS Region 7HHS Region 6HHS Region 5HHS Region 4HHS Region 3HHS Region 2HHS Region 1
W eighted % (95% C I )*
**
AI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific Islander.
*Statistically significant at p<0.05 (referent categories: Age 65 -69, Rural, White non -Hispanic, HHS Region 1).*
HHS  R egions     7: IA,K S,MO,NE
1: CT,ME,MA,NH,RI,VT  4: AL,FL,GA,K Y ,MS,NC,SC,TN  8: CO,MT,ND,SD,UT,WY
2: NJ,NY ,PR,VI   5: IL,IN,MI,MN,OH,WI  9: AZ,CA,HI,NV,GU
3: DE,DC,MD,PA,VA,WV  6: AR,LA,NM,OK ,TX  10: AK ,ID,OR,WAEquity 78
4.04.76.56.11.85.64.96.35.05.66.25.32.56.55.05.25.45.14.63.89.0
0.0 10.0 20.0 30.0 40.0 50.0 60.0Income unknownAbove poverty, >=$75KAbove poverty, <$75KBelow povertyUninsuredInsuredHigh SVIModerate SVILow SVIHHS Region 10HHS Region 9HHS Region 8HHS Region 7HHS Region 6HHS Region 5HHS Region 4HHS Region 3HHS Region 2HHS Region 1No provider recommendationHealth care provider recommended
W eighted % (95% C I )5.13.54.75.91.53.05.95.53.03.713.58.24.65.4
0.0 10.0 20.0 30.0 40.0 50.0 60.0AI/ANOther/multiple, non-HispanicNH/OPIHispanicBlack, non-HispanicWhite, non-HispanicAsianRuralSuburbanUrban18-4950-6465+MaleFemaleOverall 18+ Immunocompromised
W eighted % (95% C I )2023– 2024 COVID -19≥2 dose vaccine coverage among immunocompromised adults ≥18
years varied by urbanicity, race and ethnicity, healthcare provider recommendation and
insurance status
National Immunization Survey- Adult COVID Module (NIS -ACM)
*
**
NA: estimate not reported because denominator is <30; AI/AN: American Indian or Alaska Native; NH/OPI: Native
Hawaiian or Other Pacific Islander.
*Statistically significant at p<0.05 (referent categories: Age 18 -49, Rural, White non -Hispanic, No Provider
Recommendation, Insured).NANA**
HHS  R egions     7: IA,K S,MO,NE
1: CT,ME,MA,NH,RI,VT  4: AL,FL,GA,K Y ,MS,NC,SC,TN  8: CO,MT,ND,SD,UT,WY
2: NJ,NY ,PR,VI   5: IL,IN,MI,MN,OH,WI  9: AZ,CA,HI,NV,GU
3: DE,DC,MD,PA,VA,WV  6: AR,LA,NM,OK ,TX  10: AK ,ID,OR,WA Equity79
Acceptability
Would recommending a second dose of the 2024 – 2025 COVID -19 vaccine for
adults ages ≥65 years be acceptable to key stakeholders?
• Are there key stakeholders that would not accept the distribution of
benefits and harms?
• Are there key stakeholders that would not accept the undesirable effects in the short term for the desirable effects (benefits) in the future?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
80
Acceptability
Would recommending a second dose of the 2024 – 2025 COVID -19 vaccine for
people ages ≥6 months with moderate or severe immunocompromise be
acceptable to key stakeholders?
• Are there key stakeholders that would not accept the distribution of
benefits and harms?
• Are there key stakeholders that would not accept the undesirable effects
in the short term for the desirable effects (benefits) in the future?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
81
Acceptability
Would recommending additional doses (i.e., 3 or more) of the 2024 – 2025
COVID -19 vaccine for people ages ≥6 months with moderate or severe
immunocompromise be acceptable to key stakeholders?
• Are there key stakeholders that would not accept the distribution of
benefits and harms?
• Are there key stakeholders that would not accept the undesirable effects
in the short term for the desirable effects (benefits) in the future?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
83
EtR Domain:
Feasibility
83
Based on survey data, physicians think shared clinical decision -making
(SCDM) increases time and confusion1
1 Kempe A, Lindley MC, O'Leary ST, et al. Shared Clinical Decision- Making Recommendations for Adult Immunization: What Do Physic ians Think? J Gen Intern
Med . 2021;36(8):2283- 2291. https://pubmed.ncbi.nlm.nih.gov/33528783/ . Numbers cited based on General Internal Medicine physician responses, N=281.
68% strongly agreed
SCDM will require more
time with patients
44% either strongly or
somewhat agreed they find
it hard to explain what a
SCDM recommendation
means to patients
76% either strongly or
somewhat agreed SCDM
creates confusion
42% either strongly or
somewhat agreed they did
not know how to
implement SCDM as
intended by the ACIP
84
Domain Equity Question:
Is the intervention equally feasible to implement across all populations?
85
•Social Determinants of Health drive differences in vaccine access creating
disparities in uptake.
•Additional dose recommendations may further increase these disparities.
For example:
-Insurance: decreased access with the end of the Bridge Access Program
-Disability: increased prevalence with age creating potential challenges getting to
vaccination sites
-Setting: decreased access in setting with existing challenges (e.g., long -term care)
•In the absence of an ACIP recommendation, decreased access if required to
pay out -of-pocket.Vaccine equity considerations
Equity 86
Feasibility
Is a second dose of the 2024 – 2025 COVID -19 vaccine feasible to implement
among adults ≥65 years ?
• Is a second dose of the 2024 – 2025 COVID -19 vaccine program
sustainable?
• Are there barriers that are likely to limit the feasibility of implementing a
second dose of the 2024 – 2025  COVID -19 vaccine or require
considerations when implementing it?
• Is access to a second dose of the 2024 – 2025 COVID -19 vaccine an
important concern?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
Majority Opinion Minority Opinion 87
Feasibility
Is a second dose of the 2024 – 2025 COVID -19 vaccine feasible to implement
among persons with moderate or severe immunocompromise ?
• Is a second dose of the 2024 – 2025 COVID -19 vaccine program
sustainable?
• Are there barriers that are likely to limit the feasibility of implementing a
second dose of the 2024 – 2025 COVID -19 vaccine or require
considerations when implementing it?
• Is access to a second dose of the 2024 – 2025 COVID -19 vaccine an
important concern?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
88
Feasibility
Are additional doses (i.e., 3 or more) of the 2024 – 2025 COVID -19 vaccine
feasible to implement among persons with moderate or severe
immunocompromise ?
• Are additional doses of the 2024 – 2025 COVID -19 vaccine program
sustainable?
• Are there barriers that are likely to limit the feasibility of implementing
additional doses of the 2024 – 2025 COVID -19 vaccine or require
considerations when implementing it?
• Is access to additional doses of the 2024 – 2025 COVID -19 vaccine an
important concern?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
88
EtR Domain:
Resource Use
90
91
92
Domain Equity Question:
Is the intervention a reasonable and efficient allocation of resources
across all populations?
93
•A second dose of COVID -19 vaccine is most cost -effective in older adults in
whom disease burden is highest.
•A second dose of COVID -19 vaccine is likely more cost -effective in
populations with a higher prevalence of risk factors, such as underlying
conditions, which increase their probability of hospitalization due to
COVID -19.
-We do not have information specific to cost effectiveness of additional doses in
people with moderate or severe immunocompromiseIs the intervention a reasonable and efficient
allocation of resources across all populations?
Equity 94
•Second dose of 2024 –2025 COVID -19 vaccine in adults 65 and older
-Base case ICER: $356,534/QALY
•For all COVID -19 vaccines, if list prices were reduced, vaccination would be
more cost -effectiveSummary
Resource Use
QALY: Quality- adjusted life year95
Resource Use
Is a second dose of the 2024 – 2025 COVID -19 vaccine in adults ≥65 years  a
reasonable and efficient allocation of resources?
• What is the cost- effectiveness of a second dose of the 2024 – 2025 COVID -
19 vaccine?
• How does the cost -effectiveness of a second dose of the 2024 – 2025
COVID -19 vaccine change in response to changes in context, assumptions,
etc.?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
96
Resource Use
Is a second dose of the 2024 – 2025 COVID -19 vaccine in persons ≥6 months
of age with moderate or severe immunocompromise a reasonable and
efficient allocation of resources?
• What is the cost- effectiveness of a second dose of the 2024 – 2025 COVID -
19 vaccine?
• How does the cost -effectiveness of a second dose of the 2024 – 2025
COVID -19 vaccine change in response to changes in context, assumptions,
etc.?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
97
Resource Use
Are additional doses (i.e., 3 or more) of the 2024 – 2025 COVID -19 vaccine in
persons ≥6 months of age with moderate or severe immunocompromise a
reasonable and efficient allocation of resources?
• What is the cost- effectiveness of additional doses of the 2024 – 2025
COVID -19 vaccine?
• How does the cost -effectiveness of additional doses of the 2024 – 2025
COVID -19 vaccine change in response to changes in context, assumptions,
etc.?
oNo oProbably no oProbably yes oYes oVaries oDon’t know
Minority Opinion98
Work Group Interpretations
99
Work Group Interpretation
•A harmonized recommendation for older adults and immunocompromised persons
would ease implementation and help simplify an already complicated immunization
schedule
-Some work group members were not in favor of a harmonized recommendation but rather
supported having differing recommendations in the two populations under consideration
•Relative absence of data makes selecting the correct number of recommended doses
challenging for immunocompromised persons, especially given the heterogeneity of this population
•Despite hesitations about a shared clinical decision- making recommendation, many
Work Group members acknowledged the benefit for people with moderate or severe immunocompromise
-Allowing for flexibility in additional doses may allow these patients to time around travel, life
events, chemotherapy, etc.
100
Work Group Interpretation
•There was low uptake of more than one dose of 2023– 2024 vaccine
-Complexity of existing schedule has led to reduced adherence by clinicians
•Provider recommendations directly impact uptake, and as part of this
recommendation, provider education and ensuring providers are on board is critical to improving adherence
•While simpler vaccine recommendations aren’t perfect, there may be benefits in increasing vaccine uptake, and enhancing protection at the population level
•Focusing on number of doses of 2024– 2025 vaccine rather than additional doses in
recommendations could help reduce complexity and improve uptake
101
EtR Domain Question Work Group Judgments
Public Health
ProblemIs COVID -19 disease among older adults of public health importance? Yes
Benefits and
HarmsHow substantial are the desirable anticipated effects? Moderate/Large
How substantial are the undesirable anticipated effects? Minimal/Small
Do the desirable effects outweigh the undesirable effects? Favors intervention
ValuesDo older adults feel that the desirable effects are large relative to undesirable
effects?Moderate
Is there important uncertainty about, or variability in, how older adults value the main outcomes?Probably important uncertainty or variability/Probably not important
uncertainty or variability
AcceptabilityWould recommending a second dose of the 2024 –2025 COVID -19 vaccine for
older adults be acceptable to key stakeholders?Probably yes/Yes
FeasibilityIs a second dose of the 2024 –2025 COVID -19 vaccine feasible to implement
among older adults?Probably yes/Yes
Resource UseIs a second dose the 2024 –2025 COVID -19 vaccine in older adults a reasonable
and efficient allocation of resources?Probably yes/Yes Work Group Judgements - a second dose of 2024 –2025 COVID -19
vaccine in adults ≥65 years
102
Evidence to Recommendations Framework
Summary: Work Group Interpretations -  a second dose of 2024 –
2025 COVID -19 vaccine in adults ≥65 years
Balance of
consequencesUndesirable
consequences
clearly outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
Majority Opinion Minority Opinion 103
Is there sufficient information to move forward with a recommendation?Evidence to Recommendations Framework
Summary: Work Group Interpretations -  a second dose of 2024 –
2025 COVID -19 vaccine in adults ≥65 years
Yes No
104
Evidence to Recommendations Framework
Summary: Work Group Interpretations - a second dose of
2024– 2025 COVID -19 vaccine in adults ≥65 years
Type of
recommendationWe do not recommend
the interventionWe recommend the
intervention for individuals
based on shared clinical
decision -makingWe recommend the
intervention
105
EtR Domain Question Work Group Judgments
Public Health
ProblemIs COVID -19 disease among persons ≥6 months of age with moderate or severe
immunocompromise of public health importance?Yes
Benefits and HarmsHow substantial are the desirable anticipated effects? Moderate
How substantial are the undesirable anticipated effects? Minimal/Small
Do the desirable effects outweigh the undesirable effects? Favors intervention
ValuesDo persons ≥6 months of age with moderate or severe immunocompromise feel that the desirable
effects are large relative to undesirable effects?Moderate/Large
Is there important uncertainty about, or variability in, how persons ≥6 months of age with moderate or severe immunocompromise value the main outcomes?Probably important uncertainty or
variability/Probably not important
uncertainty or variability
AcceptabilityWould recommending an additional dose of the 2024 –2025 COVID -19 vaccine for persons ≥6
months of age with moderate or severe immunocompromise be acceptable to key stakeholders?Probably yes/Yes
FeasibilityIs an additional dose of the 2024 –2025 COVID -19 vaccine feasible to implement among persons ≥6
months of age with moderate or severe immunocompromise ?Probably yes/Yes
Resource UseIs an additional dose the 2024 –2025 COVID -19 vaccine in persons ≥6 months of age with moderate
or severe immunocompromise a reasonable and efficient allocation of resources?Probably yes/Yes Work Group Judgements - a second dose of 2024 –2025 COVID -19 vaccine in people
ages ≥6 months with moderate or severe immunocompromise
106
Evidence to Recommendations Framework
Summary: Work Group Interpretations - second dose in
people ages ≥6 months with moderate or severe
immunocompromise
Balance of
consequencesUndesirable
consequences
clearly outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
Majority Opinion Minority Opinion 107
Is there sufficient information to move forward with a recommendation?Evidence to Recommendations Framework
Summary: Work Group Interpretations – a second dose
in people ages ≥6 months with moderate or severe
immunocompromise
Yes No
108
Evidence to Recommendations Framework
Summary: Work Group Interpretations - a second dose
in people ages ≥6 months with moderate or severe
immunocompromise
Type of
recommendationWe do not recommend
the interventionWe recommend the
intervention for individuals
based on shared clinical
decision -makingWe recommend the
intervention
109
EtR Domain Question Work Group Judgments
Public Health
ProblemIs COVID -19 disease among persons ≥6 months of age with moderate or severe
immunocompromise of public health importance?Yes
Benefits and HarmsHow substantial are the desirable anticipated effects? Moderate
How substantial are the undesirable anticipated effects? Minimal/Small
Do the desirable effects outweigh the undesirable effects? Favors intervention/Unclear
ValuesDo persons ≥6 months of age with moderate or severe immunocompromise feel that the desirable
effects are large relative to undesirable effects?Moderate/Large
Is there important uncertainty about, or variability in, how persons ≥6 months of age with moderate or severe immunocompromise value the main outcomes?Probably important uncertainty or
variability/Probably not important
uncertainty or variability
AcceptabilityWould recommending additional doses (i.e., 3 or more) of the 2024 –2025 COVID -19 vaccine for
persons ≥6 months of age with moderate or severe immunocompromise be acceptable to key stakeholders?Probably yes/Yes
FeasibilityAre additional doses (i.e., 3 or more) of the 2024 –2025 COVID -19 vaccine feasible to implement
among persons ≥6 months of age with moderate or severe immunocompromise ?Probably yes/Yes
Resource UseAre additional doses (i.e., 3 or more) of the 2024 –2025 COVID -19 vaccine in persons ≥6 months of
age with moderate or severe immunocompromise a reasonable and efficient allocation of
resources?Varies Work Group Judgements - additional doses (i.e., 3 or more) of 2024 –2025 COVID -19
vaccine in people ages ≥6 months with moderate or severe immunocompromise
110
Evidence to Recommendations Framework
Summary: Work Group Interpretations - Additional
doses (i.e., 3 or more) in people ages ≥6 months with
moderate or severe immunocompromise
Balance of
consequencesUndesirable
consequences
clearly outweigh
desirable
consequences
in most settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most settingsThere is
insufficient
evidence to
determine the
balance of
consequences
111
Is there sufficient infromation to move forward with a recommendation?Evidence to Recommendations Framework
Summary: Work Group Interpretations - additional
doses (i.e., 3 or more) in people ages ≥6 months with
moderate or severe immunocompromise
Yes No
112
Evidence to Recommendations Framework
Summary: Work Group Interpretations - additional
doses (i.e., 3 or more) in people ages ≥6 months with
moderate or severe immunocompromise
Type of
recommendationWe do not recommend
the interventionWe recommend the
intervention for individuals
based on shared clinical
decision -makingWe recommend the
intervention
113
ACIP Voting Language
 In addition to previously recommended 2024 –2025 vaccination:
•ACIP recommends a second dose* of 2024– 2025 COVID -19 vaccine for
adults ages 65 years and older
•ACIP recommends a second dose**  of 2024– 2025 COVID -19 vaccine for
people ages 6 months –64 years who are moderately or severely
immunocompromised
•ACIP recommends additional doses (i.e., 3 or more doses) of 2024–
2025 COVID -19 vaccine for people ages 6 months and older who are
moderately or severely immunocompromised under shared clinical
decision -making
*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dos e of any age -appropriate 2024- 2025 COVID -19vaccine 6
months (minimum interval 2 months) after second dose.
**If previously unvaccinated or receiving initial vaccination series, at least 2 doses of 2024 –2025 vaccine are recommended, and  depending on vaccination history more may be needed.
This additional 2024– 2025 vaccine dose is recommended 6 months (minimum interval 2 months) after completion of initial vaccinati on series.114
Acknowledgements
•Kayla Calhoun
•Mary Chamberland
•Kevin Chatham -Stephens
•Jonathan Duffy
•Tarayn Fairlie
•Katherine Fleming -Dutra
•Julianne Gee
•Monica Godfrey
•Susan Goldstein
•Aron Hall
•Elisha Hall
•Fiona Havers•Jefferson Jones
•Jennifer Kriss
•Megan Lindley
•Ruth Link -Gelles
•Danielle Moulia
•Lakshmi Panagiotakopoulos
•Georgina Peacock
•Erica Rose
•Sierra Scarbrough
•Ben Silk
•Chris Taylor
•Natalie Thornburg•Megan Wallace
•Dave Wentworth
•JoEllen Wolicki
•Coronavirus and other Respiratory
Viruses Division
•COVID -NET Team
•Immunization Safety Office
•Immunization Services Division
•National Center for Immunization and Respiratory Diseases
•University of Michigan COVID -19
Vaccination Modeling Team
115
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.
Thank you
Backup
117
Weighted and Nowcast Estimates in the US for 2 -week
periods, June 23 –October 12, 2024
** These data include Nowcast estimates, which are modeled projections that may differ from weighted estimates generated at l ater dates
https://covid.cdc.gov/covid -data -tracker/#variant -proportions  121

Summary: Evidence to Recommendations Framework: Additional Doses of 2024– 2025 COVID -19 Vaccine in Older Adults and  People with Moderate or Severe Immunocompromise   Ms. Lauren Roper, MPH COVID -19 ACIP Work Group co -lead Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunization and Respiratory Diseases   •On June 27, 2024, ACIP voted to recommend 2024 –2025 COVID -19  vaccines for everyone ages 6 months and older  •On August 22, 2024, FDA approved and…


07 COVID Panagiotakopoulos 508

Clinical Considerations for the use of 2024 -2025
COVID -19 Vaccines in the United States
Lakshmi Panagiotakopoulos, MD, MPH
COVID -19 ACIP Work Group co -lead
Advisory Committee on Immunization Practices Meeting
October 23, 2024National Center for Immunizations and Respiratory Diseases
•On June 27, 2024, ACIP recommended 2024 -2025 COVID -19 vaccination for
everyone ages 6 months and older
•On August 22, 2024, FDA approved and authorized Moderna and Pfizer -
BioNTech 2024 -2025 COVID -19 vaccines
•On August 30, 2024, FDA authorized Novavax 2024 -2025 COVID -19 vaccine
•The Interim Clinical Considerations for Use of COVID -19 vaccines webpage
was updated with detailed recommendations
•A Policy Note outlining the recommendations was published in the
MMWR on September 10, 2024Current  2024 -2025 COVID -19 vaccine
recommendations
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/covid -19-vaccines -us.html
https://www.cdc.gov/mmwr/volumes/73/wr/mm7337e2.htm
ACIP: Advisory Committee on Immunization Practices | FDA: Food and Drug Administration | MMWR: Morbidity and Mortality Weekly  Report 2
•Use of 2024- 2025 COVID -19 vaccine: Routine schedule
-Proposed  recommendations for a second dose in adults ages 65
years and older
•Use of 2024- 2025 COVID -19vaccine: People with moderate or severe
immunocompromise
-Proposed  recommendations for use of additional dose(s) in people
with moderate or severe immunocompromise
•Updates to clinical considerations Outline
3
Routine schedule
People without  moderate or severe immunocompromise
•All doses should be homologous (i.e., from the same manufacturer) Current  recommendations for children ages 6 months –  4 years
Doses recommended:
Initial series of 2 Moderna vaccine doses OR 3 Pfizer-
BioNTech vaccine doses
At least 1 dose of 2024– 2025 COVID -19 vaccine, as part of
or in addition to initial series
5
•2024– 2025 COVID -19 vaccine dose is recommended at least 2 months after receipt of the
last COVID -19 vaccine dose
•mRNA COVID -19 vaccines authorized or approved for ages 6 months and older and
Novavax COVID -19 vaccine authorized for ages 12 years and older
•People who are previously unvaccinated for COVID -19 and are receiving Novavax should
complete a 2 -dose initial seriesCurrent  recommendations for people ages 5 years and older
Doses recommended:
•1 dose of 2024- 2025 COVID -19 vaccine
6
•2024– 2025 COVID -19 vaccine dose is recommended at least 2 months after receipt of the
last COVID -19 vaccine dose
•mRNA COVID -19 vaccines authorized or approved for ages 6 months and older and
Novavax COVID -19 vaccine authorized for ages 12 years and older
•People who are previously unvaccinated for COVID -19 and are receiving Novavax should
complete a 2 -dose initial seriesProposed  recommendations for people ages 5 –  64 years
Doses recommended:
•1 dose of 2024- 2025 COVID -19 vaccine
7
Proposed recommendations for adults ages 65 years and older
•If previously unvaccinated and receiving Novavax, 2 doses are recommended as
initial vaccination series followed by a third dose of any age -appropriate 2024- 2025
COVID -19 vaccine 6 months (minimum interval 2 months) after second dose.
8Doses recommended:
•2 doses of 2024- 2025 COVID -19 vaccine
•Recommended interval 6 months (minimum interval 2 months)
Recommendations for people with
moderate or severe immunocompromise
Current  recommendations for people ages 6 months and older
who are moderately or severely immunocompromised
Doses recommended:
Initial COVID -19 vaccine series*
At least 1 2024– 2025 COVID -19 vaccine dose
May receive 1 additional 2024 -2025 COVID -19
vaccine dose with option for further additional
doses of 2024- 2025 COVID -19 vaccine**
*Series of 3 homologous mRNA COVID -19 vaccine doses or 2 Novavax COVID -19 vaccine doses (if ages 12 years and older); includes revaccination after
hematopoietic cell transplant and CAR -T-cell, or B -cell- depleting therapies.
**Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare provider and personal prefe rence and
circumstances. Further additional doses should be administered at least 2 months after the last 2024 -2025 COVID -19 vaccine dose.
For more information, see  https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim- considerations -us.html#immunocompromised .
10
Proposed  recommendations for people ages 6 months and
older who are moderately or severely immunocompromised
Doses recommended:
Initial COVID -19 vaccine series*
At least 2 2024– 2025 COVID -19 vaccine doses**
Recommended interval 6 months (minimum interval 2 months)
Additional 2024 -2025 COVID -19 vaccine doses under
shared clinical decision making***
*Series of 3 homologous mRNA COVID -19 vaccine doses or 2 Novavax COVID -19 vaccine doses (if ages 12 years and older); includes revaccination after
hematopoietic cell transplant and CAR -T-cell, or B -cell- depleting therapies.
**One 2024- 2025 COVID -19 vaccine dose may be received as part of the initial vaccination series and at least one of the two doses should be received 6
months (minimum interval 2 months) after completion of the initial series.
***Additional doses should be administered at least 2 months after the last 2024 -2025 COVID -19 vaccine dose.
For more information, see  https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim- considerations -us.html#immunocompromised .
11
Updates to Clinical Considerations
•Age transitions
•Interchangeability of COVID -19 vaccines
•COVID -19 vaccination and prior SARS -CoV -2 infectionClinical considerations
13
•CDC recommends that people receive the age -appropriate vaccine product
and dosage based on their age on the day of vaccination.
•If a person moves to an older age group between vaccine doses, they
should receive the vaccine product and dosage for the older age group. For children who transition from age 4 years to age 5 years and children who are moderately or severely immunocompromised and transition from age 11 years to age 12 years, the option to administer a lower dosage is no longer authorized.Transitioning from a younger to older age group
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#age -transitions  14
•COVID -19 vaccine doses from the same manufacturer should be
administered whenever recommended. In the following circumstances, an
age-appropriate COVID -19 vaccine from a different manufacturer may be
administered:
-Same vaccine not available at the vaccination site at the time of the clinic visit
-Previous dose unknown
-Person would otherwise not receive a recommended vaccine dose
-Person starts but unable to complete a vaccination series with the same COVID- 19
vaccine due to a contraindication
A Vaccine Adverse Event Reporting System (VAERS) report is not indicated in these
circumstances.Interim Clinical Considerations on interchangeability of
COVID- 19 vaccines
15 https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#Interchangeability
•People ages 12 years and older who are initiating vaccination with
Novavax COVID -19 Vaccine (i.e., previously unvaccinated) and
receive a first dose of Novavax should complete the 2 -dose initial
vaccination series with Novavax vaccine.
•However, if more than 8 weeks have elapsed since receipt of the
first dose of Novavax, any 2024– 2025 COVID -19 vaccine (i.e.,
Moderna, Novavax, or Pfizer -BioNTech) may be administered.Additional guidance: Interim Clinical Considerations on
interchangeability of COVID- 19 vaccines – Novavax*
16 https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#Interchangeability  *For people who are not moderately or severely immunocompromised
•COVID -19 vaccination is recommended for everyone ages 6 months and
older, regardless of prior symptomatic or asymptomatic SARS -CoV -2
infection, including people with Long COVID.
•People who recently had SARS -CoV -2 infection may consider delaying a
COVID -19 vaccine dose by 3 months from symptom onset or positive test
(if infection was asymptomatic).
•Individual factors such as risk of severe COVID -19 and current indicators of
community transmission should be taken into account when determining
whether to delay getting a COVID -19 vaccination after infection.Reminder: COVID -19 vaccine and prior SARS -CoV-2
infection
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#infection  17
Summary
•Children ages 6 months –4 years
-Unvaccinated: Should receive a multidose initial series with a 2024 –2025 mRNA
vaccine
-Previously completed an initial series: Should receive 1 dose of a 2024 –2025
mRNA vaccine from the same manufacturer as the initial series
•People ages 5 –64 years:
-Should receive 1 dose of an age- appropriate 2024 -2025 COVID -19 vaccine*
•People ages 65 years and older:
-Should receive 2 doses of any 2024 –2025 COVID -19 vaccine, spaced 6 months
apart (minimum interval 2 months)**Overview of the COVID -19 vaccination schedule:
Routine vaccination
*People ages 12 -64 years who are unvaccinated and receive the 2024 -2025 Novavax COVID -19 vaccine for initial vaccination should receive 2 doses of 2024- 2025 Novavax COVID -19 vaccine.
**People ages 65 years and older who are unvaccinated and receive Novavax COVID -19 Vaccine for initial vaccination should receiv e 2 doses of 2024– 2025 Novavax COVID -19 vaccine followed by a
third dose of any 2024 –2025 COVID -19 vaccine dose 6 months after the second dose (minimum interval 2 months). 19
•Unvaccinated:
-Should receive a multidose vaccination series with an age -appropriate 2024– 2025
vaccine and receive 1 2024– 2025 dose 6 months after completing the initial series
(minimum interval 2 months)
•Previously completed an initial series:
-Should receive 2 doses of an age -appropriate 2024– 2025 COVID -19 vaccine,
spaced 6 months apart (minimum interval 2 months)
•May receive additional age -appropriate 2024 –2025 COVID -19 vaccine
doses under shared clinical decision -makingOverview of the COVID -19 vaccination schedule:
Moderate or severe immunocompromise
20
•Interim Clinical Considerations for Use of COVID -19 Vaccines in the United
States webpage continues to be rapidly updated to reflect the most recent
COVID -19 vaccine guidance
•COVID -19 vaccine recommendations have moved towards simplicity and
the standard language used for the ACIP routine immunization schedules
and General Best Practices
•Recommendations for use of additional doses in older adults and people
with moderate or severe immunocompromise will be updated following the October 2024 ACIP meeting votesSummary
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/covid -19-vaccines -us.html  21
•Mary Chamberland
•Katherine Fleming -Dutra
•Susan Goldstein
•Elisha Hall
•Lauren Roper
•JoEllen Wolicki •Coronavirus and other Respiratory
Viruses Division
•Immunization Safety Office
•Immunization Services Division
•National Center for Immunization and
Respiratory Diseases
•ACIP COVID -19 Work GroupAcknowledgements
22
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Summary: Clinical Considerations for the use of 2024 -2025  COVID -19 Vaccines in the United States Lakshmi Panagiotakopoulos, MD, MPH COVID -19 ACIP Work Group co -lead Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunizations and Respiratory Diseases  •On June 27, 2024, ACIP recommended 2024 -2025 COVID -19 vaccination for  everyone ages 6 months and older  •On August 22, 2024, FDA approved and authorized Moderna and Pfizer - BioNTech 2024 -2025 COVID -19…


01 RSV Mat Peds Chu 508

Maternal/Pediatric Respiratory Syncytial Virus (RSV)
Work Group
Helen Chu, MD, MPH
Chair, Maternal/Pediatric RSV Work Group
ACIP Meeting
October 23, 2024
1U.S. Centers for Disease Control and Prevention

All infants should be protected against severe RSV disease
with either maternal RSV vaccine or nirsevimab
Maternal vaccine
Abrysvo , Pfizer
*Either  maternal RSV vaccine or nirsevimab  is given to protect infants against severe RSV
disease – only one is needed in most instances
Pregnant persons 32 through
36 weeks’ gestation
Administer September
through January in most of
thecontinental United
States†All infants <8 months*
Second season dose for children
ages 8 –19 months at increased
risk of severe RSV disease
Administer October through
March in most of the continental
United States † (earlier the
better)
† Timing of administration for RSV immunization may differ in jurisdictions with RSV seasonality that differs from most of the continental United StatesNirsevimab
Beyfortus , Sanofi & AstraZeneca
Nirsevimab  and maternal vaccination have different
administration windows to provide optimal protection
to the infant
Forinfants born shortly before October, or during October through March who are not
protected by maternal RSV vaccine, immunize within 1 week of birth, ideally during the
birth hospitalization
•Safety and efficacy of clesrovimab  — Dr. Anushua Sinha (Merck)
•Maternal RSV vaccine safety — Dr. Malini B. DeSilva (Health Partners
Institute)
•Work Group considerations — Ms. Danielle Moulia (CDC/NCIRD)Agenda
4
Work group members (external)
ACIP Members
Helen Chu (chair)
Oliver Brooks
Denise JamiesonConsultants
Cody Meissner (Dartmouth Geisel School of Medicine)
Daniel Feikin  (World Health Organization)
Kevin Ault (Western Michigan University)
Pablo Sanchez (Nationwide Children’s Hospital)
Liaisons
James McAuley (IDSA)
Brenna Hughes (ACOG)
Nicole Chaisson  (AAFP)
Sean O’Leary (AAP)
Jennifer Schuster (PIDS)
Molly Howell (AIM)
Dana DeShon  (NAPNAP)GRADE/ EtRConsultants
Doug Campos -Outcalt
Rebecca MorganEx Officio Members
Lucia Lee (FDA -CBER)
Yodit Belew (FDA -CDER)
Prabha Viswanathan (FDA -CDER)
Yugenia Hong -Nguyen (FDA -CDER)
Sonnie Kim (NIH -NIAID)
April Killikelly (Public Health Agency of Canada)
Elissa Abrams  (Public Health Agency of Canada)
Jessica Lee (CMS/CMCS)
Terry Dalle -Tezze (HRSA)
Matthew Clark (IHS)
5
Work group members (CDC)
Tami Skoff
Angie Campbell
Michael Melgar
Amadea Britton
Amanda Payne
Noelle Molinari
Fiona Havers
Pragna PatelRuth Link -Gelles
Monica Godfrey
Heidi Moline
Hannah Rosenblum
Manisha Patel
Heather Scobie
Michele Hlavsa CDC ACIP Staff
Melinda Wharton
Stephanie Thomas
Jessica MacNeilMonica Patton
Jarrett Gartin
Dennis Wang
Jordan Singleton
Trang Nguyen Wisard
Fatimah Dawood
Agustin Lopez
Lakshmi PanagiotakopoulosCDC
Jefferson Jones (co -lead)
Danielle Moulia (co -lead)
Katherine Fleming -Dutra
Meredith McMorrow
Mila Prill
Natalie Thornburg
Aron Hall
Ismael Ortega -Sanchez
Melissa Coughlin
Jamison Pike
Lauren RoperA. Patricia Wodi
Christine Olson
Anne Hause
Andrew Leidner
David Shay
Sarah Meyer
Pedro Moro
Tarayn Fairlie
John Su
Micheal McNeal
Julianne Gee
Naomi Tepper
6
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the U.S. Centers for Disease Control and Prevention.
Thank you

Summary: Maternal/Pediatric Respiratory Syncytial Virus (RSV)  Work Group Helen Chu, MD, MPH Chair, Maternal/Pediatric RSV Work Group   ACIP Meeting October 23, 2024  1U.S. Centers for Disease Control and Prevention  All infants should be protected against severe RSV disease  with either maternal RSV vaccine or nirsevimab Maternal vaccine Abrysvo , Pfizer   *Either  maternal RSV vaccine or nirsevimab  is given to protect infants against severe RSV  disease – only one is needed in most instances …