11 COVID Wallace 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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Evidence to Recommendations Framework:
2023 –2024 (Monovalent, XBB Containing) COVID -19 Vaccine
Megan Wallace, DrPH, MPH
ACIP Meeting
September 12, 2023
Evidence to Recommendations Framework
▪Structure to describe information considered in moving from evidence to ACIP vaccine
recommendations
▪Provide transparency around the impact of additional factors on deliberations when
considering a recommendation Evidence to Recommendations ( EtR) Framework
3
44Evidence to Recommendations (EtR) Framework
EtR Domain Question(s)
Public Health Problem •Is the problem of public health importance?
Benefits and Harms•How substantial are the desirable anticipated effects?
•How substantial are the undesirable anticipated effects?
•Do the desirable effects outweigh the undesirable effects?
Values•Does the target population feel the desirable effects are large relative to
the undesirable effects?
•Is there important variability in how patients value the outcome?
Acceptability •Is the intervention acceptable to key stakeholders?
Feasibility •Is the intervention feasible to implement?
Resource Use •Is the intervention a reasonable and efficient allocation of resources?
Equity •What would be the impact of the intervention on health equity?
55Evidence to Recommendations (EtR) Framework
EtR Domain Question(s) Domain Equity Question(s)
Public Health
Problem•Is the problem of public health importance? •Does the problem impact all populations equally?
Benefits and
Harms•How substantial are the desirable anticipated effects?
•How substantial are the undesirable anticipated effects?
•Do the desirable effects outweigh the undesirable
effects?•Are the desirable and undesirable anticipated effects
demonstrated across all populations equally?
Values•Does the target population feel the desirable effects are
large relative to the undesirable effects?
•Is there important variability in how patients value the
outcome?•Is there important variability in how patients or
populations value the outcome?
Acceptability •Is the intervention acceptable to key stakeholders?•Is the intervention equally acceptable across all
populations?
Feasibility •Is the intervention feasible to implement?•Is the intervention equally feasible to implement across
all populations?
Resource Use•Is the intervention a reasonable and efficient allocation
of resources?•Is the intervention a reasonable and efficient allocation
of resources across all populations?
The intervention = 2023 –2024 (monovalent, XBB containing) COVID -19 vaccine
The problem = COVID -19
▪Should 2023 -2024 (monovalent, XBB containing) COVID -19 vaccines authorized under
EUA or approved by BLA be recommended for use in persons ≥6 months of age?
Products and ages currently authorized or approved by FDA include:
▪Moderna COVID -19 vaccine for ages 6 months and older
▪Pfizer -BioNTech COVID -19 vaccine for ages 6 months and older
Products and ages under review for authorization or approval by FDA include:
▪Novavax COVID -19 vaccine for ages 12 years and olderEvidence to Recommendations ( EtR) Framework
Policy Question
6 EUA: Emergency Use Authorization; BLA: Biologics License Application
7Bivalent COVID -19 vaccine recommendations for mRNA
COVID -19 vaccines
≥5/6 years6 months –4/5 years2 doses
Moderna3 doses
Pfizer -
BioNTechOR1 dose
Moderna1 dose
Pfizer -
BioNTechOR Unvaccinated
Previously
vaccinated
≥6 months1 dose
Moderna1 dose
Pfizer -
BioNTechOR
Note: Those ages 6 months –4 years who have previously received a single dose of Pfizer -BioNTech would need 2 additional doses. Additional doses are recommended for persons with
immunocompromising conditions.
8Proposed 2023 –2024 COVID -19 vaccine recommendations
for mRNA COVID -19 vaccines
≥ 5 years 6 months –4 years2 doses
Moderna3 doses
Pfizer -
BioNTechOR1 dose
Moderna1 dose
Pfizer -
BioNTechOR Unvaccinated
Previously
vaccinated
≥6 months1 dose
Moderna1 dose
Pfizer -
BioNTechOR
Note: Those ages 6 months –4 years who have previously received a single dose of Pfizer -BioNTech would need 2 additional doses. Additional doses are recommended for persons with
immunocompromising conditions.
▪The original Novavax COVID -19 vaccine remains authorized for use as a 2 -dose primary
series
▪The original Novavax COVID -19 vaccine can be given as booster dose in limited
situations to
–People ages 18 years and older who previously completed primary vaccination using
any FDA -approved or FDA -authorized COVID -19 vaccine
–Have not received any previous booster dose(s)
–Are unable (i.e., mRNA vaccine contraindicated or vaccine not available) or unwilling
to receive an mRNA vaccine and would otherwise not receive a booster dose
▪Authorizations or approvals for 2023 –2024 Novavax COVID -19 vaccine will be
determined by FDA with CDC recommendations to followCurrent recommendations for Novavax COVID -19 vaccine
9
▪Updated COVID -19 vaccine referred to as the “2023 –2024 COVID -19 vaccine” in this
presentation
▪Following ACIP meeting, both “updated COVID -19 vaccine” and “2023 –2024 COVID -19
vaccine” will be used to refer to the monovalent XBB.1.5 containing vaccinesCOVID -19 vaccine nomenclature
10
EtRDomain:
Public Health Problem

Weekly Population -Based Rates of COVID -19-Associated
Hospitalizations —COVID -NET, March 2020 –August 26,
2023
020406080100120140
3/7/2020
5/7/2020
7/7/2020
9/7/2020
11/7/2020
1/7/2021
3/7/2021
5/7/2021
7/7/2021
9/7/2021
11/7/2021
1/7/2022
3/7/2022
5/7/2022
7/7/2022
9/7/2022
11/7/2022
1/7/2023
3/7/2023
5/7/2023
7/7/2023Rate per 100,000 population
Week Ending DateMarch 1, 2020 –August 26, 2023
<6 months 6 months –4 years 5–11 years 12–17 years
18–49 years 50–64 years 65–74 years ≥75 years020406080100120140Rate per 100,000 population
Week Ending DateJanuary 1 –August 26, 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. Rates highest in ≥75 years, followed by
infants <6 months and adults 65 –74 years
12
13COVID -19 new hospital admissions, by week, in the United States
National Healthcare Safety Network (NHSN), August 2020 –August 2023
Source: COVID -19–associated hospitalization data reported to CDC’s National Healthcare Safety Network (NHSN).
https://covid.cdc.gov/covid -data -tracker/#trends_weeklyhospitaladmissions_select_00

1414Other pediatric vaccine preventable diseases: Annual hospitalizations per
100,000 population prior to recommended vaccines compared to COVID -19
1 https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm
2Davis MM, Patel MS, Gebremariam A. Decline in varicella -related hospitalizations and expenditures for children and adults after introduction of varicella vacci ne in the United
States. Pediatrics. 2004;114(3):786 -792. doi:10.1542/peds.2004 -0012
3Centers for Disease Control and Prevention (CDC). Direct and indirect effects of routine vaccination of children with 7 -valent pneumococcal conjugate vaccine on incidence of
invasive pneumococcal disease --United States, 1998 -2003. MMWR Morb Mortal Wkly Rep. 2005 Sep 16;54(36):893 -7. PMID: 16163262.
4COVID -NET data October 2021 –September 2022 and October 2022 –July 2023. COVID -19 rates have not been adjusted for reason for admission. COVID vaccine first introduced
in 12 -17 years in May 2021; in 5 -11 years in November 2021 and in 6 months –4 years in June 2022Hepatitis A1 Varicella2
(Chickenpox)Vaccine -type
Invasive
Pneumococcal
Disease3COVID -194
Age 5–14 years 0–4 years 0–4 years 6 months –<18 years
Time period 2005 1993 –1995 1998 –19992021 –2022
2022 –2023
Hospitalization
Burden
(Annual rate per
100,000 population)<1 29-42 405≤4 years: 92 –220
5–11 years : 15–47
12–17 years: 20 –80
1515COVID -19 Scenario Modeling Hub
https://covid19scenariomodelinghub.org/▪A multi -team effort aimed at creating and modeling planning scenarios of the mid -to
long -term COVID -19 situation
▪Scenarios developed in close collaboration with government agencies and other
stakeholders
▪Project hospitalizations and deaths

1616Assumptions of COVID -19 Scenario Modeling Hub Round 17
1. Low immune escape: immune escape occurs at a constant rate of 20% per year; high immune escape: immune escape occurs at a constant rate of 50% per year▪Sixscenarios focusing on three vaccine recommendation scenarios and two different
rates of immune escape
–No vaccine recommendation vsrecommendation for 65+ years vsuniversal
recommendation
–Low immune escape vs high immune escape1
▪Assumed vaccines reformulated to target strains circulating on June 15thof each year,
made available September 1
▪Reformulated vaccines assumed to have 65% VE against symptomatic infection with the
strain targeted by reformulation
▪Vaccine uptake based on first booster uptake (September 2021)
▪Teams required to project a minimum of 2 years into the future
▪Eight teams provided national level projections
1717Based on ensemble projections, weekly hospitalizations are likely to
increase this winter and stay within last year’s range
https://covid19scenariomodelinghub.org/

1818People ages 6 months –49 years with no underlying conditions are still
admitted to the ICU with COVID -19
COVID -NET: Underlying Medical Conditions among Patients Admitted to ICU among Children, Adolescents,
and Adults Ages 6 Months –49 Years, July 2022 –June 2023
•Relative standard errors >30%; estimates might be unstable due to small sample size
•Limited to COVID -NET hospitalizations with COVID -19-related illness as likely reason for admissionAge category% with no
underlying
conditionsOf those with no
underlying
conditions, what %
were admitted to
ICU?
6–23 months 57% 27%
2–4 years 39% 19%
5–11 years 24% 23%
12–17 years 25% 31%
18–49 years 16% 15%% admitted to ICU
with no
underlying
conditions
53%
32%
24%
22%
13%
19Provisional COVID -19 deaths, by week, in the United States,
reported to CDC
The most recent 3 weeks of mortality counts are shaded grey because NVSS reporting is <95% during this period.
Source: Provisional Deaths from the CDC’s National Center for Health Statistics (NCHS) National Vital Statistics System (NVSS ). https://covid.cdc.gov/covid -data -
tracker/#trends_weeklydeaths_weeklydeathrateaa_00

20COVID -19-associated deaths in persons ages ≥20 years (by underlying
cause of death), by age group and year –National Vital Statistics System
1Provisional data
2Partial data
Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database.
Data are from the final Multiple Cause of Death Files, 2018 -2021, and from provisional data for years 2022 -2023, as compiled fro m data provided by the 57 vital statistics
jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes COVID -19 code (U07.1) as the underlyin g cause of death. Accessed at
http://wonder.cdc.gov/mcd -icd10 -provisional.html on Aug 25, 2023 4:53:59 PM871659,054282,836
23,189110,606282,457
576433,895146,255
451 282124,776
050000100000150000200000250000300000
20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years
2020 2021 2022 Jan 1 - July 22, 2023Number of Deaths
1
21COVID -19-associated deaths in persons ages ≤19 years (by underlying
cause of death), by age group and year –National Vital Statistics System
1Provisional data
2Partial data
Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database.
Data are from the final Multiple Cause of Death Files, 2018 -2021, and from provisional data for years 2022 -2023, as compiled fro m data provided by the 57 vital statistics
jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09 -J11) or COVID -19 code (U07.1) as the underlying cause of death.
Accessed at http://wonder.cdc.gov/mcd -icd10 -provisional.html on Aug 25, 2023 4:53:59 PM3519167
91
54493
156
101292
261836
0100200300400500600
<1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years
2020 2021 2022 Jan 1 - July 22, 2023Number of Deaths
1
22Among children ≤17 years who died in -hospital, 50% had no underlying
conditions
COVID -NET: Underlying Medical Conditions among Patients with In -Hospital Death among
Children and Adolescents Ages ≤17 Years, January 2022 –June 2023
Limited to COVID -NET hospitalizations with COVID -19-related illness as likely reason for admission
* Relative standard error >30; indicates estimate might be unstable due to low sample size (n=24).Age category% with no
underlying
conditionsOf those with no
underlying
conditions, what %
died in -hospital?
≤17 years 51% 1%*% of those who died
in-hospital with no
underlying
conditions
50%
231Vogt TM , Wise ME, Bell BP , Finelli L. Declining hepatitis A mortality in the United States during the era of hepatitis A vaccination. J Infect Dis2008; 197:1282 –8.
2National Notifiable Diseases Surveillance System with additional serogroup and outcome data from Enhanced Meningococcal Disea se Surveillance for 2015 -2019.
3Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella mortality: trends before vaccine licensure in the United States, 1970 -1994. J Infect Dis. 2000;182(2): 383-390.
doi:10.1086/315714
4Roush SW , Murphy TV; Historical comparisons of morbidity and mortality for vaccine -preventable diseases in the United States. J AMA 2007; 298:2155 –63.
5 Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimat es of disease burden. J Infect Dis. 1996 Sep;174 Suppl 1:S5 -11
6 http://wonder.cdc.gov/mcd -icd10 -provisional.html on Aug 1, 2023 . COVID vaccine first introduced in 12 -17 years in May 2021; in 5 -11 years in November 2021 and in 6 months –4
years in June 2022Pediatric vaccine preventable diseases: Deaths per year in the United
States prior to recommended vaccines compared to COVID -19
Hepatitis A1Meningococcal
(ACWY)2 Varicella3 Rubella4 Rotavirus5 COVID -196
Age <20 years 11–18 years 5–9 years All ages <5 years 6 months –<18 years
Time
period1990 –1995 2000 –2004 1990 –1994 1966 –1968 1985 –1991 2022
Average
deaths
per year3 8 16 17 20≤1year: 156
1–4 years : 101
5–19 years:292
24COVID -19and Influenza -associated deaths in persons ages ≤19 years (by
underlying cause of death), by age group and year –National Vital Statistics
System
1Provisional data
2Partial data
Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database.
Data are from the final Multiple Cause of Death Files, 2018 -2021, and from provisional data for years 2022 -2023, as compiled fro m data provided by the 57 vital statistics
jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09 -J11) or COVID -19 code (U07.1) as the underlying cause of death.
Accessed at http://wonder.cdc.gov/mcd -icd10 -provisional.html on Aug 25, 2023 4:53:59 PM3519167
91
54493
156
101292
26 1836144896
0 0 01254103
018 10
0100200300400500600
<1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years
2020 2021 2022 Jan 1 - July 22, 2023Number of Deaths
COVID Influenza1
Domain Equity Question:
Does the problem impact all populations equally?

2626Age -adjusted COVID -19-associated hospitalization rates by
race and ethnicity*  —COVID -NET, October 2022 –August
2023
* Black, White, American Indian/Alaska Native and Asian/Pacific Islander people were categorized as non -Hispanic; Hispanic peopl e
could be of any race. Cumulative hospitalization rates remain highest in
American Indian/Alaska Native and Black persons
Source: COVID -NET: https://www.cdc.gov/coronavirus/2019 -ncov/covid -data/covid -net/purpose -methods.html . Data March 1, 2020 through August 26, 2023. 0246810121416
1/7/2023 2/7/2023 3/7/2023 4/7/2023 5/7/2023 6/7/2023 7/7/2023 8/7/2023Rates per 100,000 population3-week moving average rate
January –August 2023
White Black Asian/Pacific Islander American Indian/Alaskan Native Hispanic050100150200250300350Rates per 100,000 Cumulative rates
October 2022 –August 2023
2727
Risk ratio of death, invasive mechanical ventilation (IMV), and admission to intensive
care unit (ICU), by the number of underlying medical conditions among adults
hospitalized with COVID -19, March 2020 –March 2021
Kompaniyets L, Pennington AF, Goodman AB, Rosenblum HG, Belay B, Ko JY , et al. Underlying Medical Conditions and Severe Illness Among 540 ,667 Adults Hospitalized With COVID -
19, March 2020 –March 2021. Prev Chronic Dis 2021;18:210123. DOI: http://dx.doi.org/10.5888/pcd18.210123
2828Prevalence of any
condition:Selected chronic conditions by U.S. county, 2018
Based on Razzaghi H, Wang Y, Lu H, Marshall KE, Dowling NF, Paz -Bailey G,Twentyman ER, Peacock G, Greenlund KJ, Estimated County -Level Prevalence of Selected Underlying Medical Conditions
Associated with Increased Risk for Severe COVID -19 Illness -United States, 2018 MMWR Morb Mortal Wkly Rep 2020;69[945 -950]. The underlying medical conditions included in these prevalence
estimates were selected using a subset of the list of conditions with the strongest and most consistent evidence of associati on with increased risk for severe COVID -19-associated illness on CDC’s website
as of June 25, 2020 and for which questions on the BRFSS are available. https://covid.cdc.gov/covid -data -tracker/#underlying -med -conditions
(%)
2929Number of chronic conditions by age among Asian, Black, Latino/Hispanic,
and White adults in the National Health Interview Survey, 1999 to 2018
Source: 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

▪COVID -19 burden is currently lower than at previous points in the pandemic, however the
absolute number of hospitalizations and deaths is still high
▪Although hospitalization rates are currently low in some age groups, we have seen rates
increase in recent weeks and anticipate further increases as we enter respiratory virus season
▪Infants and older adults have the highest COVID -19-associated hospitalization rates
▪Children and adults with no underlying medical conditions still experience severe illness due to
COVID -19
▪Post -COVID Conditions are common following SARS -CoV-2 infection, decrease with time since
infection, and have decreased since the start of the pandemic
▪People of racial and ethnic minority groups continue to be disproportionately impacted by
COVID -19
▪High proportions of underlying conditions may put certain groups at increased risk for severe
outcomes due to COVID -19Summary
Public Health Problem
30
Public Health Problem
Work Group Interpretation
Is COVID -19 disease among persons ≥ 6 months of public health importance?
oNooProbably no oProbably yes oYesoVaries oDon’t know
EtR Domain:
Benefits and Harms

▪Data from COVID -19 vaccine manufacturers
–Moderna monovalent XBB.1.5 containing vaccine clinical trial data
–Novavax monovalent XBB.1.5 containing preclinical data
–Pfizer -BioNTech monovalent XBB.1.5 containing preclinical data
▪GRADE
–Benefits and harms of an updated COVID -19 vaccine
▪Post -authorization safety and effectiveness monitoring
–Vaccine Safety Datalink and other vaccine safety monitoring systems
–CDC vaccine effectiveness platforms
▪Additional considerations
–Benefit -risk assessment
–Modeling dataSummary of available data
33
▪Moderna
–Clinical trial data
•Randomized 101 patients to monovalent XBB.1.5 containing dose or bivalent BA.4/5 + XBB.1.5 containing dose
•Patients that received the monovalent XBB.1.5 containing dose demonstrated an increase in neutralizing
antibodies, with similar levels of neutralization across several XBB sub -variants
•Reported reactogenicity was similar to or lower than that reported from previous doses
▪Novavax
–Preclinical data
•Macaques boosted with XBB.1.5 demonstrated increased neutralizing response across several XBB
pseudoviruses
▪Pfizer -BioNTech
–Preclinical data
•Mice boosted with XBB.1.5 demonstrated increased neutralizing response across several XBB pseudovirusesAvailable data from COVID -19 vaccine manufacturers
34
▪GRADE approach was applied to assess the type and quality of evidence for the
anticipated benefits and harms of an updated COVID -19 vaccine
▪The PICO question and inclusion/exclusion criteria were intentionally narrow to best
capture evidence most applicable to what can be anticipated from this year’s vaccine
dose in the U.S., including limiting evidence to U.S. studies of an updated vaccine
formulation (i.e., bivalent mRNA vaccine)
▪Two separate PICO questions were evaluated based on dosing cut -offs
▪These narrow criteria reduced the number of studies available in the body of evidence,
however this GRADE assessment builds upon a large body of evidence from the original
monovalent vaccinesGRADE
BLA : Biologics License Application; EUA : Emergency Use Authorization 35
363636PICO Question –Adolescents and Adults
Population Persons ages 12 years and older
Intervention Updated mRNA COVID -19 vaccine
Comparison No updated vaccine
Outcomes Medically -attended COVID -19(ED/UC visits)
Hospitalization due to COVID -19
Death due to COVID -19
Post -COVID Conditions
Specified Serious Adverse Events
Reactogenicity
PICO : Population, intervention, comparison, outcomes  ED: emergency department; UC: urgent care
373737PICO Question -Infants and Children
Population Persons ages 6 months –11 years
Intervention Updated COVID -19 mRNA vaccine
Comparison No updated vaccine
Outcomes Medically -attended COVID -19(ED/UC visits)
Hospitalization due to COVID -19
Death due to COVID -19
MIS-C
Post -COVID Conditions
Specified Serious Adverse Events
Reactogenicity
PICO : Population, intervention, comparison, outcomes  ED: emergency department; UC: urgent care MIS-C: Multisystem inflammatory syndrome in children
3838Outcomes, Importance, and Data Sources
a Three options: Critical; Important but not critical; Not important for decision making
38Outcome ImportanceaData sources
Benefits
Medically -attended COVID -
19(ED/UC visits)Critical Observational studies of vaccine effectiveness
Hospitalization due to COVID -19 Critical Observational studies of vaccine effectiveness
Death due to COVID -19 Important Observational studies of vaccine effectiveness
MIS-C –pediatrics only Important Observational studies of vaccine effectiveness
Post -COVID Conditions Important Observational studies of vaccine effectiveness
Harms
Specified serious adverse events
(SAEs)Critical Safety surveillance for specified SAEs
Reactogenicity Important RCTs for monovalent doses
ED: emergency department; UC: urgent care MIS-C: Multisystem inflammatory syndrome in children
Evidence Retrieval
▪Observational Studies for Benefits (Vaccine Effectiveness)
–Published or preprint articles from International Vaccine Access Center (IVAC)
systematic reviewa
–Restricted to PICO defined population, intervention, comparison, and outcome
▪Safety Surveillance for Serious Adverse Events
–Data on safety signals identified by vaccine safety surveillance systems
–Based on input from CDC Immunization Safety Office (ISO)
▪Randomized Controlled Trials (RCTs) for Reactogenicity
–Data on reactogenicity identified by relevant phase 1, 2, or 3 RCTs from
clinicaltrails.gov
–Unpublished data from vaccine manufacturers
39a Articles were eligible for inclusion if published or uploaded to a preprint server before 6/29/2023;
Observational Data (n = 6)
▪6 records identified (one or more PICO outcomes)
▪Assessed risk of bias using Newcastle -Ottawa Scale (9 -point scale)
–For cohort studies: Selection of cohorts, Comparability of cohorts, Assessment of
outcome
–For case -control or test -negative design studies: Selection of cases and controls,
Comparability of cases and controls, Ascertainment of exposure
▪Two reviewers assessed each study for each outcome
▪Serious limitations identified by score <7
40
Pooling of Vaccine Effectiveness (VE) Estimates
▪For each outcome, assessed body of evidence for suitability for pooling
–Most representative study selected if multiple studies in same population
▪Meta -analyses conducted
▪Estimates evaluated for heterogeneity
▪Resulting pooled estimates summarize real -world data available at time of GRADE
analysis
41
4242Pooled VE = 53.1% (95% CI: 49.7% to 56.3%)*
0 10 20 30 40 50 60 70 80 90 100
Vaccine EffectivenessTenforde ,≥7 days post bivalent dose, ≥2 monovalent doses comparator
Tseng, ≥14 days post bivalent dose, ≥2 monovalent doses comparator
Pooled EstimateMedically -Attended COVID -19 (ED/UC Visits),
Adults and Adolescents (n=2)
*Pooled RR based on a fixed effects meta -analysis, using adjusted vaccine effectiveness estimates on a log scale. Fixed effects model was used for this
analysis due to imprecise estimates of the between -studies variance.
ED: emergency department; UC: urgent care
GRADE: Medically -Attended COVID -19 (ED/UC Visits), Adults
and Adolescents (n=2)
▪Observational Studies (n=2)
▪Pooled RR 0.47 (95% CI: 0.44 to 0.50)
▪No serious concerns in certainty assessment.
▪Evidence type: Low certainty
43
CI:Confidence interval; RR:Risk ratio; ED: emergency department; UC: urgent care
4444Pooled VE = 47.8% (95% CI: 29.6% to 61.4%)*
*Pooled RR based on a random effects meta -analysis, using adjusted vaccine effectiveness estimates on a log scale .
Note: 6 studies were identified in the systematic review, however 2 studies had overlapping populations and were excluded fro m the pooled
analysis .-40 -20 0 20 40 60 80 100
Vaccine EffectivenessTseng , ≥ 14 post bivalent dose, ≥2 monovalent doses comparator
Lin, ≥ 14 days post bivalent dose, ≥2 monovalent doses comparator
Link-Gelles, unvaccinated comparator
Surie, ≥2 monovalent doses comparator
Link-Gelles, unvaccinated comparator
Surie, ≥2 monovalent doses comparator
Link-Gelles, unvaccinated comparator
Surie, ≥2 monovalent doses comparator
Pooled Estimate7-59 days post
bivalent dose
60-119 days post
bivalent dose
120-179 days post
bivalent dose Hospitalization due to COVID -19, Adults and Adolescents (n=4)
GRADE: Hospitalization due to COVID -19, Adults and Adolescents
(n=4)
▪Observational Studies (n=4)
▪Pooled RR 0.52 (95% CI: 0.39 –0.70)
▪No serious concerns in certainty assessment.
▪Evidence type: Low certainty
45
CI:Confidence interval; RR:Risk ratio
4646Death due to COVID -19, Adults and Adolescents (n=2)
0
1
2
3
4
0 10 20 30 40 50 60 70 80 90 100
Vaccine EffectivenessLin,  ≥14 days post bivalent dose, ≥2 monovalent doses comparator
Tseng, ≥14 days post bivalent dose, ≥2 monovalent doses comparator
Pooled Estimate
Pooled VE = 60.5% (95%CI: 40.7% to 73.7%)*
*Pooled RR based on a fixed effects meta -analysis, using adjusted vaccine effectiveness estimates on a log scale. Fixed effects model was used for this
analysis due to imprecise estimates of the between -studies variance.
47▪Observational Studies (n=2)
▪Pooled RR 0.39 (95% CI: 0.26 to 0.59)
▪Serious concern for inconsistency was present. The magnitude of effect and 95%
confidence intervals from the two studies in the body evidence varied widely,
possibly reflecting differences in study methods.
▪Evidence type: Very lowGRADE: Death due to COVID -19, Adults and Adolescents (n=2)
CI:Confidence interval; RR:Risk ratio
Post -COVID -Conditions, Adults and Adolescents
▪No published or preprint captured in systematic review
▪Common reasons for exclusion
–Review article
–Self-reported vaccination status
–Combines vaccine platforms
–Not a VE study
–Vaccination as a therapeutic (after infection)
▪Data not captured in the systematic review indicate that COVID -19 vaccine provides
some protection against post -COVID conditions
48
4949Specified Serious Adverse Events (Myocarditis/Pericarditis)
Incidence Rate of Verified Myocarditis/Pericarditis in the 0 to 7 Days After mRNA COVID -19 Vaccination among Persons Aged 12 –39 Years by Product,
Age Group, Sex.
Monovalent Booster Dose Bivalent Booster Dose
Age group Cases/Doses AdministeredIncidence Rate/Million Doses
(95% CI)Cases/Doses Administered Incidence Rate/Million Doses (95% CI)
Pfizer
Male
12-17 y - - 0/55649 0.0 (0.0 –53.8)
12-15 y 5/81613 61.3 (19.9 –143.0) - -
16-17 y 9/47874 188.0 (86.0 –356.9) - -
18-29 y 7/166973 41.9 (16.9 –86.4) 1/60338 16.6 (0.4 –92.3)
30-39 y 3/197554 15.2 (3.1 –44.4) 0/97171 0.0 (0.0 –30.8)
Female
12-17 y - - 0/57776 0.0 (0.0 –51.9)
12-15 y 0/84114 0.0 (0.0 –35.6) - -
16-17 y 2/55004 36.4 (4.4 –131.3) - -
18-29 y 1/240226 4.2 (0.1 –23.2) 0/95162 0.0 (0.0 –31.5)
30-39 y 1/268412 3.7 (0.1 –20.8) 0/133305 0.0 (0.0 –22.5)
Moderna
Male
18-29 y 7/109337 64.0 (25.7 –131.9) 0/22247 0.0 (0.0 –134.7)
30-39 y 1/149468 6.7 (0.2 –37.3) 1/41820 23.9 (0.6 –133.2)
Female
18-29 y 1/156707 6.4 (0.2 –35.6) 0/35393 0.0 (0.0 –84.6)
30-39 y 2/191765 10.4 (1.3 –37.7) 0/55816 0.0 (0.0 –53.7)
Source: Goddard K, et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID -19 Vaccination Among Children and Younger Adults in the United
States .Ann Intern Med. 2022;175:1169 -1771. Bivalent booster data through March 11, 2023. Data unpublished.
Specified Serious Adverse Events (Anaphylaxis), Adults and
Adolescents
▪Among persons 12 and older, based on events occurring in a 0 -1 day risk interval after
vaccination, the estimated incidence of confirmed anaphylaxis among adolescents and
adults was:
–4.8 (95% CI 3.2 -6.9) per million doses of Pfizer -BioNTech original monovalent vaccines
–5.1 (95% CI: 3.3 -7.4) per million doses of Moderna original monovalent vaccines
–There were fewer cases of anaphylaxis post dose 2 compared with dose 1
50
Source : Klein et al. Surveillance for Adverse Events After COVID -19 mRNA Vaccination. JAMA. 2021;326(14):1390 -1399
GRADE: Specified Serious Adverse Events , Adults and
Adolescents
▪Observational Studies (n=2)
▪Two specific, rare SAEs have been associated with vaccination through safety
surveillance
▪No serious concerns in certainty assessment.
▪Evidence type: Low certainty
51
CI:Confidence interval; RR:Risk ratio; SAE: serious adverse events
52Reactogenicity*, Severe (Grade ≥3), Adults and Adolescents
(n=4)
BLA: Biologics License Application
*Reactogenicity data are from the original monovalent Moderna and Pfizer randomized controlled trials
GRADE: Reactogenicity, Severe (Grade ≥3), Adults and
Adolescents
▪Randomized Controlled Trials (n=4)
▪Pooled RR 4.83 (95% CI: 4.50 –5.18)
▪Very serious concern for indirectness, as the body of evidence did not include
anyone who received an updated dose, were from a prior period of the pandemic,
and excluded persons with prior COVID -19 infection, pregnant or breastfeeding
women, and persons who were immunocompromised.
▪Evidence type: Low certainty
53CI:Confidence interval; RR:Risk ratio
54Summary of GRADE –Adults and Adolescents
Outcome Importance Design
(# of studies)Findings Evidence
type
Benefits
Medically -attended
COVID -19 (ED/UC visit)Critical OBS (2)Updated COVID -19 vaccine is effective in preventing medically
attended COVID -19 ED/UC visits.Low
Hospitalization due to
COVID -19Critical OBS (4) Updated COVID -19 vaccine prevents hospitalization due to COVID -19 Low
Death due to COVID -19 Important OBS (2) Updated COVID -19 vaccine prevents death due to COVID -19 Very low
Post -COVID Conditions Important OBS (0) - -
Harms
Serious adverse events Critical OBS (2)In post -authorization safety monitoring, myocarditis and anaphylaxis
were rare but more common following vaccinationLow
Reactogenicity Important RCT (4) Severe reactions within 7 days were more common in vaccinated Low
ED: emergency department; UC: urgent care; OBS: observational; RCT: randomized controlled trial
55Infants and Children Benefits GRADE:
Adolescent and adult benefits downgraded for indirectness
▪Systematic review for benefits of vaccination did not capture a sufficient amount of
data for evidence synthesis in pediatrics, however data in adults provide indirect
evidence of benefits
Adolescents and Adults Pediatrics (with indirectness
downgrade)
Outcome Design
(# of studies)Pooled VE  (95% CI) Evidence type Evidence type
Medically -attended COVID -19
(ED/UC visit)OBS (2) 53.1 (49.7 -56.3) Low Very low
Hospitalization due to COVID -
19OBS (4) 47.8 (29.6 -61.4) Low Very low
Death due to COVID -19 OBS (2) 60.5 (40.7 -73.7) Very low Very low
ED: emergency department; UC: urgent care; OBS: observational
56Specified Serious Adverse Events (Myocarditis/Pericarditis),
Infants and Children
Source: Goddard et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID -19 Vaccination Among Children and Younger Adults in the Unite d
States. Annals of Internal Medicine. https://www.acpjournals.org/doi/10.7326/M22 -2274▪A single observational study from the Vaccine Safety Datalink (VSD) evaluated chart -
reviewed cases of myocarditis occurring among children aged 5 -11 years following a
monovalent booster based on events occurring in a 7 -day risk interval after vaccination vs.
a comparison interval in vaccinated individuals.
Table. Incidence Rate of Verified Myocarditis/Pericarditis in the 0 to 7
Days After mRNA COVID -19 Vaccination among Persons Aged 5 -11 Years
by Age Group and Sex.
Age groupCases/Monovalent
Booster Doses
AdministeredIncidence Rate/Million Doses (95%
CI)
Pfizer
Male
5-11 y 0/50415 0.0 (0.0 -59.4)
Female
5-11 y 0/49261 0.0 (0.0 -60.8)
Specified Serious Adverse Events (Anaphylaxis), Infants and
Children
▪Risk of anaphylaxis in children can be indirectly inferred from the known risk in persons
ages 12 and older
–4.8 (95% CI 3.2 -6.9) per million doses of Pfizer -BioNTech original monovalent
–5.1 (95% CI: 3.3 -7.4) per million doses of original Moderna monovalent
–There were fewer cases of anaphylaxis post dose 2 compared with dose 1
Source: Klein et al. Surveillance for Adverse Events After COVID -19 mRNA Vaccination. JAMA. 2021;326(14):1390 -1399 57
GRADE: Specified Serious Adverse Events, Infants and Children
▪Observational Studies (n=2)
▪Two specific, rare SAEs have been associated with vaccination through safety
surveillance
▪Serious concern for indirectness, as the body of evidence for myocarditis was only
among children aged 5 -11 receiving a monovalent booster and the body of
evidence for anaphylaxis was among adults and adolescents aged 12 years and
older receiving a primary series
▪Evidence type: Very low certainty
58CI:Confidence interval; RR:Risk ratio; SAEs: serious adverse events
5959Reactogenicity*, Severe (Grade ≥3) (n=2), Infants and
Children
59
 *Reactogenicity data are from the original monovalent Moderna and Pfizer randomized controlled trials.
GRADE: Reactogenicity, Severe (Grade ≥3) (n=2)
▪RCTs (n=2)
▪Pooled RR 4.69 (95% CI: 3.43 –6.41)
▪Very serious concern for indirectness was present. The available body of evidence
did not include anyone who received an updated dose and excluded children were
immunocompromised. While children with a history of COVID -19 infection were
included in the safety sets, the RCTs were conducted at a time of low
seroprevalence.
▪Evidence type: Low certainty
60CI:Confidence interval; RR:Risk ratio; RCTs: randomized controlled trials
6161Summary of GRADE –Infants and Children
61Outcome Importance Design
(# of studies)Findings Evidence
type
Benefits
Medically -attended
COVID -19 (ED/UC visit)Critical OBS (2)Updated COVID -19 vaccine is effective in preventing medically
attended COVID -19 ED/UC visits, although the body of evidence is
limited to indirect data from adolescents and adultsVery low
Hospitalization due to
COVID -19Critical OBS (4)Updated COVID -19 vaccine prevents hospitalization due to COVID -19,
although the body of evidence is limited to indirect data from
adolescents and adultsVery low
Death due to COVID -19 Important OBS (2)Updated COVID -19 vaccine prevents death due to COVID -19, although
the body of evidence is limited to indirect data from adolescents and
adultsVery low
Post -COVID Conditions Important OBS (0) - -
MIS-C Important OBS (0) - -
Harms
Serious adverse events Critical OBS (2)In post -authorization safety monitoring, two specific adverse events
have been associated with vaccinationVery Low
Reactogenicity Important RCT (2) Severe reactions within 7 days were more common in vaccinated Low
ED: emergency department; UC: urgent care; OBS: observational; RCT: randomized controlled trial
62▪Due to lower uptake of Novavax COVID -19 vaccine, no post -authorization vaccine
effectiveness estimates from prior COVID -19 vaccine formulation are available
▪Post -authorization safety data are also limited by the low number of doses
administered1
–Available data from the Vaccine Adverse Event Reporting System (VAERS) are
consistent with those from preauthorization clinical trials
–Most VAERS reports were classified as nonserious
•The most commonly reported AEs included dizziness, fatigue, and headache
–No new safety concerns were identifiedNovavax vaccine effectiveness and safety
1. https://www.cdc.gov/mmwr/volumes/72/wr/mm7231a4.htm
6363103
16
19
75424
56
51
308476
76
95
414
0 50 100 150 200 250 300 350 400 450 5006 months –4 years
18 –49 years5 –11 years
12 –17 yearsEstimated COVID -19 hospitalizations prevented over 6 months for
every million mRNA COVID -19 doses , among those age <50 years, by
age group
Based on hospitalization rates from Spring 2023 (low) , December
2022 (high winter), Summer 2022 (high past year)
64Calculating Risk: Myocarditis and COVID -19 vaccines
1 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2023 -02/slides -02-24/COVID -02-Shimabukuro -508.pdf
2https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2022 -02-04/11 -COVID -Moulia -508.pdf
3https://www.cdc.gov/vaccines/acip/meetings/downloads/slides -2022 -02-04/04 -COVID -Kracalic -508.pdf
4https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm?s_cid=mm7114e1_w▪Limited data to inform myocarditis risk after bivalent COVID -19 vaccine booster dose
–Myocarditis rates following booster doses in adolescent and young adult males are lower than rates
following primary series , but estimates are limited by fewer numbers of doses for both the bivalent
boosters and the previous monovalent boosters administered in VSD1
▪Myocarditis risk lower with longer time between doses
–Rates of myocarditis lower with extended interval between dose 1 and dose 2 for primary series2
–Longer interval between updated doses may also impact myocarditis rates
▪Most individuals with myocarditis/pericarditis have fully recovered at follow -up3
▪The risk of adverse cardiac outcomes were 1.8 –5.6 times higher after SARS -CoV-2 infection than after
mRNA COVID -19 vaccination among males ages 12 -17 years4
656519–95hospitalizations prevented
5 –19 ICU admissions prevented
0 –1death preventedEstimated COVID -19 hospitalizations prevented vs. potential
myocarditis cases for every million mRNA COVID -19 vaccine doses: 12
–17-year -olds1
Per million doses in 12 –17-year -olds over 6 months2
0 myocarditis3cases in 55,649 males with a bivalent dose
0 myocarditis3cases in 57,776 females with a bivalent dose
1 Results were adjusted to account for potential incidental findings of SARS -CoV-2 infection by multiplying the estimated hospital izations, ICU admissions, and deaths prevented by the estimated
percent of COVID -NET hospitalizations that are likely due to COVID -19 among 12 –17-year -olds during on Omicron BA.5 predominant period (55%)
2 Ranges presented for benefits are based on the high and low incidence scenarios presented on slides 7 and 8
3Based on preliminary Pfizer -BioNTech bivalent booster safety data from VSD (incident rate/million doses): 0 (95% CI: 0 -54) in m ales and 0 (95% CI: 0 -52) in females
6666Universal vaccine recommendations projected to prevent about 400,000
hospitalizations and 40,000 deaths over the next 2 years compared with no
recommendation, regardless of level of immune escape
https://covid19scenariomodelinghub.org/
6767Compared with only vaccinating those 65+ years, universal vaccine recommendations
projected to prevent about 200,000 more hospitalizations and 15,000 more deaths
over the next 2 years
https://covid19scenariomodelinghub.org/
Domain Equity Question:
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/ethnicity1,2
–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 Are the desirable and undesirable anticipated effects
demonstrated across all populations equally?
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9619452/
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9763212/ 69
▪Monovalent XBB containing COVID -19 vaccines increase the immune response against the currently
circulating variants
▪Last year’s updated vaccine was effective at preventing medically attended COVID -19, hospitalization
due to COVID -19, and death due to COVID -19
▪Accumulating evidence that COVID -19 vaccination reduces Post -COVID Conditions among both children
and adults
▪COVID -19 vaccines have a high degree of safety
–Rare events of myocarditis and anaphylaxis have been seen in post -authorization studies
–Unlikely that updating the formulation would increase adverse event rates
▪Benefits are anticipated in all age groups; benefits of COVID -19 vaccines vary by ageand incidence of
COVID -19 hospitalizations
▪Benefits outweigh risks in age groups for which risk of myocarditis is highest
▪Modeling projects more hospitalizations and deaths averted when updated doses are universally
recommended compared to no recommendation or recommended only for persons ≥65 yearsSummary
Benefits and Harms
70
Benefits and Harms
How substantial are the desirable anticipated effects?
•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
Minority opinion Majority opinion
Benefits and Harms
How substantial are the undesirable anticipated effects?
•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
Benefits and Harms
Do the desirable effects outweigh the undesirable effects?
•What is the balance between the desirable effects relative to the
undesirable effects?
oFavors intervention (2023 –2024 COVID -19 vaccine)
oFavors comparison (no vaccine)
oFavors both
oFavors neither
oUnclear
EtRDomain:
Values

75Americans’ assessment of COVID -19 in the U.S., February
2023
A nationally representative survey of U.S. adults conducted February 21 -28 by web using the Gallup Panel
GALLUP . At Year Three, Americans Split on Whether Pandemic Is Over. https://news.gallup.com/poll/471734/year -three -americans -split -whether -pandemic.aspx Accessed August
29, 202362%
30%
8%
0%10%20%30%40%50%60%70%80%90%100%
4/6/2020
5/6/2020
6/6/2020
7/6/2020
8/6/2020
9/6/2020
10/6/2020
11/6/2020
12/6/2020
1/6/2021
2/6/2021
3/6/2021
4/6/2021
5/6/2021
6/6/2021
7/6/2021
8/6/2021
9/6/2021
10/6/2021
11/6/2021
12/6/2021
1/6/2022
2/6/2022
3/6/2022
4/6/2022
5/6/2022
6/6/2022
7/6/2022
8/6/2022
9/6/2022
10/6/2022
11/6/2022
12/6/2022
1/6/2023
2/6/2023What’s your impression of the coronavirus situation in the U.S. today?
% Getting better % Staying about the same % Getting worse
7630% of U.S. adults report they are very or moderately
concerned about getting COVID -19, August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 10.0 20.0 35.2 34.8
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Overall (N=4,289)
Weighted %Very concerned Moderately A little Not at all
77Concern about serious COVID -19 illness in family, March 2023
Monmouth University. Life Mostly Back to Pre -Covid Normal. Life Mostly Back to Pre -Covid Normal | Monmouth University Polling Institute | Monmouth University Accessed
August 29, 2023

Domain Equity Question:
Is there important variability in how patients or
populations value the outcome?

79Concern about getting COVID -19 by race and ethnicity, August
2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 8.812.718.67.8
27.422.222.117.9
36.832.632.536.2
27.032.526.838.1
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Other, non-Hispanic (N=346)Hispanic (N=629)Black, non-Hispanic (N=479)White, non-Hispanic (N=2,835)
Weighted %Very concerned Moderately A little Not at all
80Concern about getting COVID -19 by urbanicity, U.S., August
2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 10.88.412.2
17.020.321.2
35.234.536.2
37.036.930.4
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Rural (N=765)Suburban (N=2,078)Urban (N=1,446)
Weighted %Very concerned Moderately A little Not at all
81Concern about getting COVID -19 by income, August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 7.59.413.314.3
19.923.017.619.7
36.832.734.933.6
35.834.934.232.4
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%$75,000+ (N=2,076)$50,000-$74,999 (N=789)$25,000-$49,999 (N=801)$24,999 or less (N=623)
Weighted %Very concerned Moderately A little Not at all
▪As of February 2023, the majority of Americans felt COVID -19 was getting better
▪30% of U.S. adults report they are very or moderately concerned about getting COVID -
19
▪Half of U.S. adults continue to have concern about a family member becoming seriously
ill from COVID -19
▪Racial and ethnic minority groups, those living in urban areas, and those with lower
incomes are more concerned about getting COVID -19Summary
Values
Values
Criteria 1:
Does the target population feel that that the desirable effects are large relative
to undesirable effects?
•How does the target population view the balance of desirable versus undesirable
effects?
•Would patients/caregivers feel that the benefits outweigh the harms and burden?
•Does the population appreciate and value the 2023 –2024 COVID -19 vaccine?
oMinimal oSmall oModerate oLarge oVaries oDon’t know
Minority opinion Majority opinion
Values
Criteria 2:
Is there important uncertainty about, or variability in, how much people value
the main outcomes?
•How much do individuals value each outcome in relation to the other outcomes?
•Is there evidence to support those value judgements?
•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 outcomesMinority opinionMajority opinion
EtR Domain:
Acceptability

86Intent to get new, updated COVID -19 vaccine, August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
24.9 17.6 18.2 13.6 25.7
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Overall (N=4,283)
Weighted %Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
8787Bivalent COVID -19 vaccine receipt and intent among adults 18
years and older, June 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data
44.7 3.4
10.523.8
8828.1
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Among unvaccinated (N=783)Among 1+ vaccinated (N=3,248)Received bivalent COVID-19 vaccine Definitely will get vaccine
Probabaly will get vaccine or unsure Probably/definitely will not get vaccine
8888Top concerns or issues regarding bivalent COVID -19 vaccine,
June 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data Received 1+ doses of COVID -19 vaccine
but not the bivalent vaccineUnvaccinated with any COVID -19
vaccine
Definitely will •Too busy or kept forgetting (36.3%) Omitted (N<30)
Probably will or unsure •Had enough vaccines (27%)
•Too busy or kept forgetting (22.2%)
•No provider recommendation (19.8%)
•Unknown serious side effects (12.8%)•Unknown serious side effects (37.1%)
Probably or definitely will NOT •Unknown serious side effects (43.1%)
•Had enough vaccines (42.4%)
•Not enough studies (33.8%)
•Do not trust gov’t/pharma (30%)
•Effectiveness (29.8%)
•Heart -related issues (28.6%)•Unknown serious side effects (56.5%)
•Do not trust gov’t/pharma (50.5%)
•Not enough studies (47.1%)
•Heart -related issues (39.6%)
•Effectiveness (36.1%)
8989Confidence in vaccine safety is higher for influenza and other
routine adult vaccines than for COVID -19 vaccine, June 2023
Analysis limited to those who responded to all three survey questions (N=4,164). Omitted category of respondents who answered “not sure” is <1%.
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data
30.834.323.8
34.829.525.5
27.326.429.9
7.29.820.8
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Routine Adult VaccinesFlu VaccineCOVID-19 VaccineVaccine is completely safe Very safe Somewhat safe Not at all safe
9090Vaccine recommendation by healthcare provider
(among those eligible to receive the vaccine), June 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 72.2
63.3 62.2
57.3 56.2
01020304050607080
Flu (N=4,169) Shingles (N=2,144) Pneumonia (N=1,851) Tetanus (N=4,158) COVID-19 (N=4,171)Percent reporting HCP recommendation
Axis Title
9191Vaccine receipt by healthcare provider recommendation
(among those eligible to receive the vaccine), June 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data
9.453.211.951.763.4
70.794.381.389.189.2
0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 90.0 100.0ShinglesTetanusPneumoniaFluCOVID-19Provider recommendation No provider recommendation
(N=2,419)
(N=1,752)
(N=3,083)
(N=1,086)
(N=2,489)
(N=1,669)
(N=1,393)
(N=751)(N=658)(N=1,193)
▪Data from the Fall 2022 DocStyles survey were analyzed to examine the prevalence of COVID -19
vaccination attitudes and practices among health care providers (HCPs) caring for women of
reproductive age, and to assess whether providers recommended and offered or administered the
COVID -19 vaccines to their pregnant patients
▪Overall, 82.9% of providers reported recommending COVID -19 vaccination to women of reproductive
age, and 54.7% offered or administered the vaccine in their practice
▪Among HCPs who cared for pregnant patients, obstetrician -gynecologists were more likely to
recommend COVID -19 vaccination to pregnant patients ( 94.2% ) than were family practitioners/internists
(82.1% )
▪HCPs were more likely to offer or administer COVID -19 vaccination onsite to pregnant patients if they
also offered or administered influenza and Tdap vaccines COVID -19 vaccine recommendation and administration by
U.S. health care providers among women of reproductive age
Fall 2022 DocStyles, unpublished data (data will be published in MMWR on September 28, 2023) 92
Domain Equity Question:
Is the intervention equally acceptable across all
populations?

9494COVID -19 vaccine safety confidence by race and ethnicity,
August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
20.622.318.923.2
32.226.324.624.9
32.730.536.328.6
14.520.920.223.3
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Other, non-Hispanic (N=347)Hispanic (N=626)Black, non-Hispanic (N=476)White, non-Hispanic (N=2,830)
Weighted %Vaccine is completely safe Very safe Somewhat safe Not at all safe
9595COVID -19 vaccine safety confidence by income, August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
26.921.218.114.7
29.726.020.120.5
25.530.637.135.7
17.822.224.729.1
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%$75,000+ (N=2,075)$50,000-$74,999 (N=788)$25,000-$49,999 (N=797)$24,999 or less (N=619)
Weighted %Vaccine is completely safe Very safe Somewhat safe Not at all safe
9696COVID -19 vaccine safety confidence by urbanicity, August
2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
16.423.124.4
20.227.027.0
33.429.429.6
30.020.519.0
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Rural (N=762)Suburban (N=2,075)Urban (N=1,442)
Weighted %Vaccine is completely safe Very safe Somewhat safe Not at all safe
97Intent to get new, updated COVID -19 vaccine by age, August
2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
43.12815.8
18.619.416.3
13.116.221.2
9.111.816.3
1624.530.3
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Age 65+ (N=1,091)Age 50-64 (N=1,109)Age 18-49 (N=2,083)
Weighted %Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
9898Percent of people receiving COVID -19 vaccine by age
*Data cutoff on May 10, 2023 is due to the end of the Public Health Emergency (PHE) on May 11, 2023
Data source: VTrcks , IIS, Federal Pharmacy Program, Federal Entities Program, U.S. Census Bureau 10 -year July 2019 National Population Estimates
https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends . Accessed 9/5/2023
December 14, 2020 –May 10, 2023*
99Intent to get new, updated COVID -19 vaccine by race and
ethnicity, August 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data
21.822.227.925.5
19.521.71716.3
22.722.119.416.2
17.111.61413.6
18.922.421.728.5
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%Other, non-Hispanic (N=347)Hispanic (N=626)Black, non-Hispanic (N=478)White, non-Hispanic (N=2,832)
Weighted %Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
10
0100Estimated percent of people ≥ 18 years reporting COVID -19
vaccination by race/ethnicity
Source: National Immunization Survey Adult COVID Module. https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends. Accessed 9/5/2023National Immunization Survey Adult COVID Module, April 22, 2021 –March 25, 2023

10
1101COVID -19 v accine receipt by healthcare provider
recommendation by race and ethnicity, June 2023
A nationally representative sample of U.S. adults aged 18 years and older
IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data
66.164.165.262.4
94.58983.689.4
0 10 20 30 40 50 60 70 80 90 100Other, non-HispanicHispanicBlack, non-HispanicWhite, non-HispanicProvider recommendation No provider recommendation
(N=1,102)(N=1,690)
(N=253)
(N=220)
(N=306)
(N=298)
(N=170)
(N=132)
10
2102Percent of pregnant people ages 18 -49 years who are up to date* with
COVID -19 vaccines overall and by race and ethnicity –Vaccine Safety
Datalink, September 1, 2022 –July 29, 2023
*Up to date is defined as the percent of pregnant people who received an updated bivalent dose before or during pregnancy, wit h the denominator including those pregnant at
least 1 day during the specified month ending date, and the numerator including those who received an updated bivalent dose. CDC recommended bivalent boosters to persons
age ≥12 years starting September 1, 2022. Data on bivalent boosters among pregnant persons was available starting September 4 , 2022, and includes doses received starting
September 1, 2022
CDC. COVID -19 vaccination among pregnant people aged 18 -49 years overall, by race and ethnicity, and date reported to CDC –Vacc ine Safety Datalink,* United States.
https://covid.cdc.gov/covid -data -tracker/#vaccinations -pregnant -women Accessed August 9, 2023

▪Vaccine receipt varies by age and race/ethnicity
▪Fall vaccination intent increases with increasing age; those ages 65+ have the highest
percentage reporting they “definitely” or “probably” will get the vaccine compared to
other age groups
▪Confidence in COVID -19 vaccine safety differs across the population
▪Compared to other vaccines, COVID -19 vaccines were recommended the least by
health care providers
▪Those who received a provider recommendation overall and by race and ethnicity were
more likely to receive the recommended vaccine
▪Encouraging health care providers to recommend, offer, and administer COVID -19
vaccines, could help reinforce vaccine confidence and increase coverage1Summary
Acceptability
103
1. Fall 2022 DocStyles, unpublished data
Acceptability
Is the 2023 –2024 COVID -19 vaccine 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?
oNooProbably no oProbably yes oYesoVaries oDon’t know
Minority opinion Majority opinion
EtR Domain:
Feasibility

▪Vaccines with a monovalent XBB.1.5 composition will be the first COVID -19 vaccines to
be available directly from the manufacturers as part of the commercial market, rather
than through the United States Government (USG)
▪The public will continue to be directed to Vaccines.gov to find providers offering COVID -
19 vaccine
▪While providers will no longer be required to report inventory to Vaccines.gov after
vaccines transition to being available on the commercial market, they will continue to
be encouraged to report voluntarily
–Providers are also strongly encouraged to report the minimum age (in months and
years) for whom a location can administer vaccine
▪CDC will continue its efforts to make sure that all people have access to COVID -19
medical countermeasures and know where to find product now and in the future Fall COVID -19 vaccine transition
CDC. HHS Commercialization Transition Guide: Sunsetting the US Government COVID -19 Vaccine Distribution Program. https://www.cdc.gov/vaccines/covid -19/downloads/HHS -
Commercialization -Transition -Guide -508.pdf Accessed August 4, 2023 106
▪Inclusion of COVID -19 vaccines in Vaccines for Children (VFC) will likely result in more pediatricians
stocking the vaccine
▪There will be single dose vial presentations and smaller minimum order quantities
–Directly addresses concerns from health care providers (HCPs), likely to reduce wastage, eases logistics
and helps with storage capacity limitations
•Moderna, 12+ years: single dose vial (10 -pack) and manufacturer -prefilled syringes (10 -pack)
•Moderna, 6 months –11 years: single dose vial (10 -pack)
•Novavax, 12+ years: 5 -dose multi -dose vial (2 vials per carton)
•Pfizer, 12+ years: single dose vial (10 -pack), limited quantity of manufacturer -prefilled syringes (10 -
pack)
•Pfizer, 5 –11 years: single dose vial (10 -pack)
•Pfizer, 6 months –4 years: 3 -dose multi -dose vial (10 -pack)
▪Preparation is the same or simpler than it was before
–Moderna preparation is the same (no dilution)
–Novavax preparation is the same (no dilution)
–Pfizer preparation is simplified (currently 2 presentations require dilution; for 2023 –2024 COVID -19
vaccine, ONLY little peds formulation require dilution) Feasibility of vaccine implementation
Immunization Services Division, internal planning documents
▪Storage and handling will be the SAME as it is now
–Moderna: Frozen until expiration; 30 days at refrigerator storage
–Novavax: Stable at 2 -8°C (refrigerator storage); 9 -month shelf life; use within 12 hours
of first puncture
–Pfizer: Ultra -cold storage until expiration; 10 weeks at refrigerator storage
•Ultra -cold storage continues to be a challenge; most provider offices do not have a
unit
▪Dose volume for Pfizer is simplified (all doses are 0.3mL)
▪Moderna now only has two presentations, reducing the chance for errorsFeasibility of vaccine implementation, cont’d
Immunization Services Division, internal planning documents
▪There are now THREE seasonal vaccines and preventative products1for respiratory
diseases to manage
–More seasonal vaccines to manage
–Limited storage space and more vaccines
–More opportunities for vaccine administration errors
▪Providers have to adapt to new cap/label colors
–Moderna: 6 months –11 years is blue cap/ green label; 12+ years is blue cap/ blue
label
–Novavax: 12+ is blue
–Pfizer: 6 months –4 years is yellow ; 5 –11 years is blue ; 12+ years is gray
▪Moderna, Novavax and Pfizer all have products with blue caps, introducing opportunity
for errorBarriers to implementation
1 COVID -19 vaccine, Influenza vaccine,  RSV vaccine, and nirsevimab , a long -acting monoclonal antibody for RSV prevention in infants
Immunization Services Division, internal planning documents
Domain Equity Question:
Is the intervention equally feasible to implement
across all populations?

11
1111There are disparities in uninsured status that could impact
who gets a COVID -19 vaccine
0%5%10%15%20%25%
White Black American Indian
and Alaska NativeAsian Native Hawaiian
and Other Pacific
IslanderHispanic or LatinoPercent of US adults without health insurance
U.S. Census Bureau, 2021 American Community Survey 1 -year estimates: https://data.census.gov/table?q=race&t=Health+Insurance&tid=ACSST1Y2021.S2701
▪CDC will provide access to COVID -19 vaccines for uninsured individuals once COVID -19
vaccines become commercially available1
▪Uninsured children will be able to receive COVID -19 vaccines through the existing
Vaccines for Children (VFC) program1
–The VFC program offers vaccines at no low or no cost to eligible children through a national network of
participating health care providers2
▪Adults who are uninsured or underinsured will be able to receive no -cost COVID -19
vaccines through the temporary Bridge Access Program for COVID -19 Vaccines. This
program consists of two components:
–Public health infrastructure: through state immunization programs, State and local health departments and HRSA -
supported health centers will provide no -cost COVID -19 vaccines to adults who are uninsured or underinsured
–Participating retail pharmacies: CVS, Walgreens, and eTrueNorth will continue to provide no -cost COVID -19
vaccines to adults who are uninsured or underinsured3CDC vaccine programs for people who are uninsured
1.CDC. HHS Commercialization Transition Guide: Sunsetting the US Government COVID -19 Vaccine Distribution Program. https://www.cdc.gov/vaccines/covid -
19/downloads/HHS -Commercialization -Transition -Guide -508.pdf Accessed August 4, 2023
2.CDC. VFC Information for Parents. https://www.cdc.gov/vaccines/programs/vfc/parents/index.html Accessed August 30, 2023
3.CDC. Bridge Access Program for COVID -19 Vaccines. https://www.cdc.gov/vaccines/programs/bridge/index.html Accessed September 7, 2023 112
▪CDC's Bridge Access Program for COVID -19 Vaccines and COVID -19 vaccine
implementation plans are intentionally designed to overcome barriers to access and
availability
–This includes design for maximized proximity to no -cost COVID -19 vaccines among
populations of people who are uninsured or underinsured
▪CDC and HHS continue to invest in health systems and programs that support vaccine
access and outreach in underserved communities –such as HRSA -Supported Health
Centers, Rural Health Clinics, and State and local health departments
–These networks can be leveraged for access to COVID -19 vaccines as well as other
needed medicinesAvailability of vaccines in underserved communities
ASPR Administration for Strategic Preparedness & Response. Commercialization of COVID -19 Medical Countermeasures. https://aspr.hhs.gov/COVID -19/Pages/FAQ -
Commercialization.aspx Accessed August 25, 2023 113
▪Implementation of the 2023 –2024 COVID -19 vaccine will likely reduce wastage, ease
logistics, help with storage capacity limitations and reduce the chance of errors
▪Nevertheless, there will be now be three seasonal vaccines for respiratory diseases, in
which there will be more seasonal vaccines to manage, limited storage space due to
additional vaccines and more opportunities for vaccine administration errors
▪Vaccines will continue to be accessible after commercialization, with readily available
resources for those who are uninsured, underinsured, or who reside in underserved
communitiesSummary
Feasibility
114
Feasibility
Is the 2023 –2024 COVID -19 vaccine feasible to implement among
populations currently recommended for a dose?
•Is the 2023 –2024 COVID -19 vaccine program sustainable?
•Are there barriers that are likely to limit the feasibility of implementing the 2023 –
2024 COVID -19 vaccine or require considerations when implementing it?
•Is access to the 2023 –2024 COVID -19 vaccine an important concern?
oNooProbably no oProbably yes oYesoVaries oDon’t know
EtR Domain:
Resource Use

▪COVID -19 vaccination is a cost –effective intervention, particularly in persons ages ≥65
years in which the vaccine is cost saving
▪Cost -effectiveness estimates in those ages ≥50 years were robust to input changes
across plausible ranges
▪Cost -effectiveness estimates in those 18 -49 years were sensitive to changes in inputs
–If vaccine effectiveness or hospitalization rates are higher than anticipated, the cost -
effectiveness estimates would be more favorable
▪Cost -effectiveness estimates are not yet available for pediatric populationSummary
117
Domain Equity Question:
Is the intervention a reasonable and efficient
allocation  of resources across all populations?

▪COVID -19 vaccination is most cost -effective in older adults in which disease burden is
highest compared to younger adults
▪COVID -19 vaccination is likely more cost -effective in populations with risk factors, such
as underlying conditions, which increase their probability of hospitalization due to
COVID -19
▪Additional work is ongoing to evaluate cost -effectiveness in the pediatric populationsIs the intervention a reasonable and efficient allocation  of
resources across all populations?
119
Resource Use
Is the 2023 –2024 COVID -19 vaccine a reasonable and efficient allocation of
resources?
•What is the cost -effectiveness of the 2023 –2024 COVID -19 vaccine?
•How does the cost -effectiveness of the 2023 –2024 COVID -19 vaccine change in
response to changes in context, assumptions, etc.?
oNooProbably no oProbably yes oYesoVaries oDon’t know
Minority opinion Majority opinion
Summary and Work Group Interpretations
▪The burden of COVID -19 varies by age and underlying condition status with those ages ≥65 years and
those with multiple underlying conditions having the highest risk of severe outcomes due to COVID -19
▪COVID -19 burden is currently lower than at previous points in the pandemic, however there are still
thousands of hospitalizations and hundreds of deaths each week
▪Children and adults ages 5 –49 years had the lowest hospitalization rates overall
–Severe outcomes occur in this age group, including in people with no underlying medical conditions
▪Although hospitalization rates are currently low, we have seen rates increase in recent weeks and
anticipate further increases as we enter respiratory virus season
▪Majority of U.S. population has some level of immunity due to infection, vaccination, or both
–Vaccine and infection -induced immunity wane and new variants have emerged, suggesting that
susceptibility remains and may increase over time
▪Racial and ethnic minority groups have been disproportionately affected by COVID -19Summary and Work Group Interpretation:
Public Health Burden
122
▪Monovalent XBB containing COVID -19 vaccines increase the immune response against the currently
circulating variants
▪Last year’s updated vaccine was effective at preventing medically attended COVID -19, hospitalization
due to COVID -19, and death due to COVID -19
▪COVID -19 vaccines have a high degree of safety
–Unlikely that updating the formulation would increase adverse event rates
▪Benefits are anticipated in all age groups; benefits of COVID -19 vaccines vary by age, and incidence of
COVID -19 hospitalizations
▪Benefits outweigh risks in age groups for which there is a risk of myocarditis
▪Modeling projects more hospitalization and deaths averted when updated doses are universally
recommended compared to no recommendation or recommended only for persons ≥65 yearsSummary and Work Group Interpretation:
Benefits and Risks
123
▪Work Group considered non -universal policy options, with considerable discussion around the magnitude of benefits in
the young, healthy population
▪As part of these deliberations, Work Group requested additional data on severe illness due to COVID -19 in those with
and without underlying conditions
–No group that clearly had no risk of severe illness
–The vast majority of the US population has an underlying condition that would qualify under a risk based
recommendation
•Prevalence of overweight and obesity alone is >70% of adults1
–Risk based recommendation would not allow access to COVID -19 vaccines for all that wanted them
▪Shared clinical decision making could create barriers to vaccination and may not effectively target those at highest risk
▪COVID -19 epidemiology remains uncertain and non -universal recommendations would need to be quickly revisited if
there was an increase in burden
▪Still substantial COVID -19 disease burden and simple, stable recommendations may increase vaccine coverage over time
▪Work Group emphasized that COVID -19 recommendations should be reviewed on an ongoing basis as more is learned
about COVID -19 seasonality and disease burden in the futureSummary and Work Group Interpretation:
Considerations Regarding a Universal vs. Non -universal Policy
1National Health Statistics Reports; https://stacks.cdc.gov/view/cdc/106273124
▪Burden of severe illness due to COVID -19 is lowest among children ages 5 –17 years
▪Despite lower burden relative to other age groups, hundreds of deaths due to COVID -19 occurred in this
age group in 2021 and 2022
–Half of pediatric COVID -19 deaths were in individuals with no underlying conditions
▪Number of COVID -19 hospitalizations and deaths in this age group are comparable to the burden seen in
other vaccine preventable diseases for which there are universal recommendations
▪Potential additional benefits of vaccination , such as prevention of post -COVID conditions and potential
for reduced school absenteeism
▪Risk of myocarditis appears lower than the risk observed following primary series doses
–Potentially lower due to increased interval between doses
–Certainty is limited by relatively lower sample size of booster recipients in VSD
▪Future COVID -19 epidemiology remains uncertain and the low disease burden we are currently seeing
may not last
▪After a robust discussion, Work Group was supportive of a universal recommendation at this timeSummary and Work Group Interpretation:
COVID -19 vaccine recommendations for children
125
126EtR Domain Question Work Group Judgments
Public Health
ProblemIs COVID -19 of public health importance? Yes
Benefits and HarmsHow substantial are the desirable anticipated effects? Large
How substantial are the undesirable anticipated effects? Small
Do the desirable effects outweigh the undesirable effects? Favors intervention
ValuesDoes the target population feel the desirable effects are large
relative to the undesirable effects?Moderate
Is there important variability in how patients value the
outcomes?Probably important
uncertainty or variability
AcceptabilityIs the 2023 -2024 COVID -19 vaccine acceptable to key
stakeholders?Yes / Probably yes / Varies
Feasibility Is the 2023 -2024 COVID -19 vaccine feasible to implement? Yes
Resource UseIs the 2023 -2024 COVID -19 vaccine a reasonable and efficient
allocation of resources?Yes
127Evidence to Recommendations Framework
Summary: Work Group Interpretations
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
Minority opinion Majority opinion
128Evidence to Recommendations Framework
Summary: Work Group Interpretations
Type of
recommendationWe do not recommend
the interventionWe recommend the
intervention for individuals
based on shared clinical
decision -makingWe recommend the
intervention
ACIP recommends 2023 –2024 (monovalent, XBB containing)
COVID -19 vaccines as authorized under Emergency Use
Authorization (EUA) or approved by Biologics License Application
(BLA) in persons ≥6 months of ageProposed ACIP Voting Language
129
Clinical Considerations
130
▪Everyone ages 5 years and older is recommended to receive 1 dose of a 2023 –2024
mRNA COVID -19 vaccine
▪Children ages 6 months –4 years should complete a multi -dose initial series (2 doses of
Moderna or 3 doses of Pfizer -BioNTech mRNA COVID -19 vaccine) with at least one dose
of the 2023 –2024 COVID -19 vaccine1
▪People who are moderately or severely immunocompromised should complete a 3 -
dose initial series with at least one dose of the 2023 –2024 COVID -19 vaccine and may
receive 1 or more additional 2023 –2024 COVID -19 vaccine doses2
▪Bivalent mRNA COVID -19 vaccines are no longer recommended in the United StatesProposed 2023 –2024 mRNA COVID -19 vaccine
recommendations:
1.Children ages 6 months –4 years that previously received a single dose of Pfizer -BioNTech vaccine should receive 2 doses of Pfi zer-BioNtech vaccine.
2.Additional details in the interim clinical considerations 131
Bivalent recommendations Proposed 2023 –2024
vaccine recommendationsRationale
Everyone ages 6 years and
older recommended for a
single bivalent doseEveryone ages 5 years and
older recommended for a
single 2023 –2024 doseEliminates complex
recommendations for 5 -year -
olds
Two Moderna dosages
authorized for 6 months –5
years, depending on
vaccination history and
immune statusAll Moderna doses in ages 6
months –11 years are now 25
µcgReduces the number of
COVID -19 vaccine products in
use
Optional 2ndbivalent dose for
those ages 65 years and olderNo additional dose
recommendation at this timeWill monitor epidemiology
and vaccine effectiveness to
determine if additional doses
are neededKey changes from bivalent mRNA recommendations
Acknowledgements
133▪Monica Godfrey
▪Danielle Moulia
▪Hannah Rosenblum
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Sarah Meyer
▪Elisha Hall
▪Joanna Regan
▪Susan Goldstein
▪Mary Chamberland
▪JoEllen Wolicki
▪Josephine Mak
▪Morgan Najdowski
▪Lauren Roper
▪Karen Broder
▪Melisa Shah▪Mehreen Meghani
▪Romeo Galang
▪Sascha Ellington
▪Sierra Scarbrough
▪Amadea Britton
▪Jefferson Jones
▪Aron Hall
▪Barbara Mahon
▪COVID -NET
▪COVID -19 Scenario Modeling Hub
▪University of Michigan COVID -19 Vaccination Modeling
Team
▪Immunization Safety Office
▪Immunization Services Division
▪Coronavirus and other Respiratory Viruses Division
▪National Center for Immunization and Respiratory
Diseases
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.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Thank you
Additional Clinical Considerations
Proposed recommendations for children aged 6
months –4 years who are notmoderately or
severely immunocompromised
▪All doses should be homologous (i.e., from the same manufacturer)
▪All Moderna doses in ages 6 months –11 years are now 25 µcg Proposed recommendations for children aged 6 months –4 years
without immunocompromise
Doses recommended:
▪Initial series of 2 Moderna vaccine doses OR 3
Pfizer -BioNTech vaccine doses
▪At least 1 dose of 2023 –2024 COVID -19 vaccine
Vaccinated
1 dose any
Pfizer -
BioNTech2 doses any
Pfizer -
BioNTech3 or more
doses any
Pfizer -
BioNTech
2023 –2024
Moderna2 doses
2023 –2024
Pfizer -
BioNTech3 doses
0.3 mL/3 µg 0.25 mL/25 µgPreviously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
OR
2023 –2024
Moderna1 dose
0.25 mL/25 µg2023 –2024
Pfizer -
BioNTech2 doses
0.3 mL/3 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/3 µgProposed recommended 2023 –2024 COVID -19 mRNA vaccines for people who are NOT immunocompromised,
aged 6 months –4 years*
1 dose any
Moderna2 or more
doses any
Moderna
*For information about administration intervals and people who transition from age 4 years to age 5 years during an mRNA vaccination series, see Table 1 in the
Interim Clinical Considerations for Use of COVID -19 vaccines .COVID -19 vaccination
status as of
September 2023
Proposed recommendations for people aged 5
years and older who are notmoderately or
severely immunocompromised
Proposed recommendations for people aged 5 years and older
without immunocompromise
Doses recommended:
•1 dose of 2023 –2024 COVID -19 vaccine ,
regardless of prior vaccination history
▪New harmonized age cutoff for recommendations for young children for Moderna and
Pfizer -BioNTech COVID -19 vaccines
▪Resulting in simplified recommendations for 5 -year -olds
▪All Moderna doses in ages 6 months –11 years are now 25 µcg
▪2023 –2024 COVID -19 vaccine dose is recommended at least 2 months after receipt of
the last COVID -19 vaccine dose
Vaccinated
Previously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
2023 –2024
Moderna1 dose
0.25 mL/25 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/10 µgProposed r ecommended 2023 –2024 COVID -19 mRNA vaccines for people who are NOT immunocompromised,
aged 5 –11 years*
1 or more
doses any
mRNA
*For information about administration intervals and people who transition from age 4 years to age 5 years during an mRNA vaccination series, see Table 1 in the
Interim Clinical Considerations for Use of COVID -19 vaccines .ORCOVID -19 vaccination
status as of
September 2023
Previously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
2023 –2024
Moderna1 dose
0.5 mL/50 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/30 µgProposed r ecommended 2023 –2024 COVID -19 mRNA vaccines for people who are NOT immunocompromised, aged ≥12 years*
1 or more
doses any
mRNAVaccinated
1 or more doses Novavax
or Janssen, including in
combination with any
mRNA vaccine dose(s)
*For information about administration intervals ,see Table 1 in the Interim Clinical Considerations for Use of COVID -19 vaccines .ORCOVID -19 vaccination
status as of
September 2023
Proposed recommendations for people who are
moderately or severely immunocompromised
Proposed recommendations for people aged ≥6 months who are
moderately or severely immunocompromised
Doses recommended:
▪Initial COVID -19 vaccine series*
▪At least 1 2023 –2024 COVID -19 vaccine dose
▪May receive 1 or more additional 2023 -2024
mRNA COVID -19 vaccine doses**
*Series of 3 homologous mRNA COVID -19 vaccine doses at time of initial vaccination. This could also include
a history of receipt of 1 or more doses of Novavax or Janssen, including in combination with mRNA vaccine
dose(s).
**Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare
provider and personal preference and circumstances. Further additional doses should be administered at
least 2 months after the last 2023 -2024 COVID -19 vaccine dose.
1 dose any
Pfizer -
BioNTech2 doses any
Pfizer -
BioNTech3 or more
doses any
Pfizer -
BioNTech
2023 –2024
Moderna3 doses
2023 –2024
Pfizer -
BioNTech3 doses
0.3 mL/3 µg 0.25 mL/25 µgCOVID -19 vaccination
status as of
September 2023
Previously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
2023 –2024
Moderna2 doses
0.25 mL/25 µg2023 –2024
Pfizer -
BioNTech2 doses
0.3 mL/3 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/3 µgProposed r ecommended 2023 –2024 COVID -19 vaccines for people who ARE moderately or severely immunocompromised,
aged 6 months –4 years*
1 dose any
Moderna
2023 –2024
Moderna1 dose
0.25 mL/25 µgVaccinated
2 doses any
Moderna3 or more
doses any
Moderna
*For information about administration intervals, people who transition from age 4 years to age 5 years during an mRNA vaccina tion series, and administration
of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID -19 Vaccines. OR
2023 –2024
Moderna3 doses
0.25 mL/25 µgPreviously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
2023 –2024
Moderna2 doses
0.25 mL/25 µgProposed r ecommended 2023 –2024 COVID -19 vaccines for people who ARE moderately or severely immunocompromised,
aged 5 –11 years*
2 doses any
Moderna
2023 –2024
Moderna1 dose
0.25 mL/25 µg2023 –2024
Pfizer -
BioNTech2 doses
0.3 mL/10 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/10 µg1 dose any
Moderna1 dose any
Pfizer -
BioNTech2 doses any
Pfizer -
BioNTech3 or more doses
any mRNA
vaccineVaccinated
*For information about administration intervals, people who transition from age 4 years to age 5 years or age 11 years to age 12years during an mRNA
vaccination series, and administration of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID -19Vaccines. OR
2023 –2024
Pfizer -
BioNTech3 doses
0.3 mL/10 µgOR
2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/10 µg2023 –2024
Moderna1 dose
0.25 mL/25 µgCOVID -19 vaccination
status as of
September 2023
Previously received
COVID -19 vaccine(s)
Recommendations
for 2023 –2024
vaccine, by
manufacturerUnvaccinated
ORProposed r ecommended 2023 –2024 COVID -19 vaccines for people who ARE moderately or severely immunocompromised,
aged ≥12 years*
2 doses
any
Moderna
OR1 dose
any
Moderna1 dose
any
Pfizer -
BioNTech2 doses
any
Pfizer -
BioNTech1 or more doses of
Novavax or Janssen,
including in
combination with any
mRNA vaccine dose(s)Vaccinated
2023 –2024
Moderna3 doses
0.5 mL/50 µg2023 –2024
Pfizer -
BioNTech3 doses
0.3 mL/30 µg2023 –2024
Moderna2 doses
0.5 mL/50 µg2023 –2024
Moderna1 dose
0.5 mL/50 µg2023 –2024
Moderna1 dose
0.5 mL/50 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/30 µg2023 –2024
Pfizer -
BioNTech2 doses
0.3 mL/30 µg2023 –2024
Pfizer -
BioNTech1 dose
0.3 mL/30 µg3 or more
doses any
mRNA
vaccine
*For information about administration intervals, people who transition from age 11 years to age 12 years during an mRNA vacci nation series, and administration
of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID -19 Vaccines. COVID -19 vaccination
status as of
September 2023
▪Everyone aged 5 years and older are recommended get one 2023 –2024 COVID -19
vaccine to be up to date.
▪Children aged 6 months –4 years and people who are moderately or severely
immunocompromised need multiple doses, including at least one 2023 –2024 COVID -
19 vaccine dose to be up to date.
▪People who are moderately to severely immunocompromised may get additional doses
of the 2023 –2024 COVID -19 vaccine.Proposed 2023 –2024 COVID -19 Vaccine Up to Date
Definition
Simultaneous administration of
COVID -19 and other vaccines
▪In accordance with General Best Practice Guidelines for Immunization , routine
administration of all age -appropriate doses of vaccines simultaneously (i.e.,
administering more than one vaccine on the same clinic day or “coadministration”) is
recommended for children, adolescents, and adults if there are no contraindications at
the time of the healthcare visit.
–Providers may simultaneously administer COVID -19, influenza, and respiratory syncytial virus (RSV) vaccines to
eligible patients; the Health Alert Network (HAN) published on September 5, 2023 may be consulted for
additional information about simultaneous administration of these vaccines.
–Simultaneous administration of COVID -19 vaccine and nirsevimab (a long -acting monoclonal antibody for certain
infants and young children for prevention of RSV) is recommended
–Coadministration of COVID -19 and RSV vaccine for older adults is acceptable
–There are additional considerations if administering an orthopoxvirus vaccine and COVID -19 vaccine Simultaneous administration of COVID -19 and other vaccines
Interim Clinical Considerations for Use of COVID -19 Vaccines | CDC
Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations ofthe Advisory Committee on Immunization
Practices —United States, 2023 | MMWR (cdc.gov)
Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over | CDC
Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Mpox Outbreak | Mpox | Poxvirus | CDC

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation  use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Evidence to Recommendations Framework: 2023 –2024 (Monovalent, XBB Containing) COVID -19 Vaccine Megan Wallace, DrPH, MPH ACIP Meeting  September 12, 2023 Evidence to…


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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
COVID -19 Vaccine Implementation
Georgina Peacock, MD, MPH
Immunization Services Division
Centers for Disease Control and PreventionEnsuring no -cost, timely access to the 2023 -2024 COVID -19 vaccines
COVID -19 activities are integral to the broader Fall respiratory virus vaccine program goals
Protect Promote Communicate Implement
Protect Americans
from influenza, COVID -
19, and RSVPromote vaccine
uptake among those at
higher risk:
•Older adults and
long -term care
facility residents
•People with
underlying medical
conditions
•People who are
pregnant
•ChildrenCommunicate new and
rapidly changing
recommendations for
influenza, COVID -19,
and RSVImplement Fall
vaccination equitably,
including through the
Bridge Access Program
for COVID -19 VaccinesFall Respiratory Virus Vaccine Program
Commercialization of COVID -19 Vaccines
What will change
▪Transition of federal procurement and
distribution of all COVID -19 vaccines to more
traditional public/private model
▪End of CDC COVID -19 Provider Agreement
▪Vaccine data reporting transitions to routine
reporting processes for jurisdictions that
have signed data use agreement (DUA) with
CDCWhat will not change
▪Evidence -based vaccination program to
develop recommendations, monitor safety
and effectiveness, and strengthen vaccine
confidence
▪CDC’s commitment to ensuring access to
COVID -19 vaccines at no cost
Snapshot of COVID -19 vaccine data reporting plans
Administration data from reporting states National Immunization Surveys
Bridge Access Program for COVID -19 Vaccines
Other surveillance systems
Vaccine Safety Datalink
Other data sources
Omnibus surveys
Internet panel survey of pregnant people
Distribution data

Promotion and Communication
COVID -19 Communications will be part of a Pan -
Respiratory Efforts
Encourage vaccination as the first tool in our toolbox for respiratory virus season
Additional tools to protect yourself:
•washing hands with soap and water
•staying home if you are feeling sick
•avoiding close contact with sick people
•avoiding touching your eyes , nose, and mouth
•Cover your mouth and nose when coughing or sneezing
•ensuring the air around us is well -ventilated
•wearing a mask if you’re at risk or if COVID -19 hospitalizations are high in your
area
•Practice good health habits, such as cleaning and disinfecting frequently
touched surfaces, and taking care of your health
Communication Components and Tactics
Healthcare Providers:
•Owned Media
•Social media
•Press release
•Earned Media
•Medscape article
•Trade outlets
•Paid (boosted) social media
•Medical society partner outreachConsumers:
•Owned Media
•Social media posts
•Earned media
• Blanket (matte) release in English
and Spanish
• Op-edpiece
•Paid media
•TV ads in select markets
•Boosted social media posts
•Partner outreach and tool
kit

▪COVID -19 –Bridge Access Program
–Audience: No -cost COVID -19 vaccines for underinsured
and insured adults
–Kickoff: September 2023
–Campaign work underway
▪COVID -19 –General
–Kickoff: September/October 2023
–Communication materials underway
▪RSV
–Kickoff: September 2023
–Older adult vaccine with HCP recommendation and RSV immunization for infants
–Audience: Communication materials under development with a focus on cliniciansCOVID -19 Outreach Activities
Implementation
Resources for partners
▪vaccines.gov
–All sites offering COVID -19and flu vaccines
–This week: sites offering Bridge Access Program COVID -19 vaccines
Ensuring no -cost, timely access to COVID -19 vaccines
▪Timely access for all
▪Established access for those with health insurance
▪Established access for children
▪Ensuring no -cost access for adults
▪Program design to maximize proximity
▪Program design to maximize equity
Availability of COVID vaccine
▪Federal contracts have been modified to allow hastened delivery of the
2023 -2024 COVID -19 vaccines within public health infrastructure for
children and adults
•Projected first dose availability: within 48 hours of CDC
recommendation
▪Contracts with participating retail pharmacies have been modified to
allow doses with the Bridge Access Program to begin simultaneously with
doses offered through private insurance
•Projected first dose availability: within 48 hours of CDC
recommendation
▪Commercial insurance is expected to be available in the same timeframe
Ensuring no -cost, timely access to COVID -19 vaccines
▪Timely access for all
▪Established access for those with insurance
▪Established access for children
▪Ensuring no -cost access for adults
▪Program design to maximize proximity
▪Program design to maximize equity
Insurance plans will cover the 2023 -2024 COVID -19
vaccines immediately
▪The Affordable Care Act (ACA) requires insurers to cover most ACIP -recommended
vaccines without cost sharing by the next coverage year1
–COVID -19 vaccines are on recommended schedules since February 20232
▪Section 3203 of the CARES Act expedites coverage of COVID -19 vaccines beyond
that which is required of most preventive services
–As of January 5, 2021: “plans and issuers must cover COVID -19 vaccines and their
administration without cost sharing immediately once the vaccine becomes
authorized under an EUA or approved under a BLA, and according to the scope of
the applicable EUA or BLA”3
▪In July 2023, HHS issued guidance to payors to prepare to cover COVID -19
vaccination with the onset of COVID -19 vaccine commercialization4
1. 42 U.S. Code §300gg –13 -Coverage of preventive health services. https://www.law.cornell.edu/uscode/text/42/300gg -13
2. CDC Immunization Schedules by Age: https://www.cdc.gov/vaccines/schedules/hcp/index.html
3. FAQs about Affordable Care Act Implementation Part 50: https://www.dol.gov/sites/dolgov/files/EBSA/about -ebsa/our -activities/resource -center/faqs/aca -part -50.pdf
4. CMS Administrator Brooks -LaSure Letter to Payors Regarding Coverage of COVID -19 Vaccines Post Commercialization, July 13 2023: https://www.hhs.gov/about/news/2023/07/13/cms -administrator -brooks -lasure -letter -
to-payors -regarding -coverage -covid -19-vaccines -post -commercialization.html
People with Medicare and Medicaid will also have
access to COVID -19 vaccines at no cost
▪COVID -19 vaccines covered under Medicare Part B without cost -sharing
▪Inflation Reduction Act, passed in August 2022, includes key provisions:
–Eliminates cost -sharing for all ACIP -recommended vaccines under
Medicaid and Medicare Part D/equivalent plans
–Guarantees that nearly 50 million Medicare beneficiaries and more than
80 million Medicaid beneficiaries will have access to all vaccines
recommended by ACIP without cost -sharing
Children 0 through 18 years of age who meet
at least one of the criteria:
•Medicaid eligible
•Uninsured, or
•American Indian/Alaska Native, or
•Underinsured*VFC Program Eligibility
* Eligible to receive vaccine only through an enrolled Federally Qualified Health
Center (FQHC), Rural Health Center (RHC) or a deputized provider under
Delegation of Authority

•Approximately 50% of US children
•>$4 billion program
•CDC distributes more than 75M doses of pediatric
vaccine each year, the vast majority of which is
purchased through VFC.
•Nearly 38,000 VFC provider locations across 61
VFC awardee jurisdictionsVFC Program Reach
The VFC program has reduced racial, ethnic, and
economic disparities in infant immunization in the US

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation  use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. COVID -19 Vaccine Implementation Georgina Peacock, MD, MPH Immunization Services Division Centers for Disease Control and PreventionEnsuring no -cost, timely access to…