cdc.gov/coronavirus

Evidence to Recommendation Framework: 

Moderna COVID-19 vaccine in children 

ages 6 months – 5 years 

&

Pfizer-BioNTech COVID-19 vaccine in children

ages 6 months – 4 years

Sara Oliver, MD, MSPH

ACIP Meeting

June 17, 2022
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
 Should vaccination with Moderna COVID-19 vaccine (2-doses, 25μg, IM) 

be recommended for children 6 months–5 years of age, under an Emergency 

Use Authorization?

 Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3μg, IM) 

be recommended for children 6 months–4 years of age, under an Emergency 

Use Authorization?

Evidence to Recommendations (EtR) Framework

Policy Question 
Evidence to Recommendations (EtR) Framework:

PICO Question

5

Population Children ages 6 months – 4 years or 5 years 

Intervention

Moderna COVID-19 vaccine (mRNA-1273) 2-doses, 25μg, IM

–or–

Pfizer-BioNTech COVID-19 vaccine (BNT162b2) 3-doses, 3μg, IM

Comparison No vaccine

Outcomes

Symptomatic laboratory confirmed COVID-19 

Hospitalization due to COVID-19

Multisystem inflammatory syndrome in children (MIS-C)

Asymptomatic SARS-CoV-2 infection 

Serious adverse events 

Reactogenicity grade ≥3
Evidence 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?
Evidence to Recommendations (EtR) Framework

EtR Domain

Public Health Problem

Benefits and Harms

Values

Acceptability

Feasibility

Resource Use

Equity

Data for young children overall

will be presented 
Evidence to Recommendations (EtR) Framework

EtR Domain

Public Health Problem

Benefits and Harms

Values

Acceptability

Feasibility

Resource Use

Equity

Use of mRNA COVID-19 

vaccines broadly

will be presented 
Evidence to Recommendations (EtR) Framework

EtR Domain

Public Health Problem

Benefits and Harms

Values

Acceptability

Feasibility

Resource Use

Equity

Manufacturer-specific

data

will be presented 
EtR Domain: Public Health Problem
Trends in number of COVID-19 cases in the United States 

among persons of all ages

Source: COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. Accessed 6/16/2022 

January 23, 2020 – June 14, 2022

Cases: 85,681,615

7-day 

average: 

103,935

cases
COVID-19 weekly cases per 100,000 population among 

children ages 0 – 17 years by age group – United States

March 1, 2020 – June 14, 2022

Reporting may be incomplete for the most recent two weeks of data, denoted by the grey box. 

Source: COVID Data Tracker, https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed 6/14/2022

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Incident cases per 100,000 population

Case earliest date by end of week

<1 year

1–4 years

5–11 years

12–17 years

Total number of COVID-19 cases

<1 year 578,168

1–4 years 1,945,389

5–11 years 5,106,673

12–17 years 5,691,196
COVID-19-associated hospitalizations among children and 

adolescents ages 6 months – 17 years, COVID-NET

March 21, 2020 – May 7, 2022

Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

0

1

2

3

4

5

6

7

8

9

10

3/21/20 6/21/20 9/21/20 12/21/20 3/21/21 6/21/21 9/21/21 12/21/21 3/21/22

Hospitalization rate per 100,000 population

Week End Date

6 months-4 years

5-11 years

12-17 years
Cumulative COVID-19-associated hospitalizations among 

children and adolescents ages 6 months – 17 years, COVID-NET

March 21, 2020 – May 7, 2022

Source: COVID-NET, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. Accessed 5/21/2022

0

20

40

60

80

100

120

140

3/21/20 6/21/20 9/21/20 12/21/20 3/21/21 6/21/21 9/21/21 12/21/21 3/21/22

Cumulative hospitalization rate per 100,000 

population

Week Ending Date

6 months-4 years

5-11 years

12-17 years
COVID-19 deaths in children and adolescents by age based 

on death certificate data, National Center for Health 

Statistics, January 1, 2020 – May 11, 2022

The provisional counts for COVID-19 deaths are based on a current flow of mortality data in the National Vital Statistics System. National provisional counts include deaths 

occurring within the 50 states and the District of Columbia that have been received and coded as of the date specified. It can take several weeks for death records to be 

submitted to National Center for Health Statistics (NCHS), processed, coded, and tabulated. Therefore, the data may be incomplete, and will likely not include all deaths that 

occurred during a given time period, especially for the more recent time periods. 

Source: https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Counts-by-Age-in-Years/3apk-4u4f/data. Accessed 5/14/22 

0

50

100

150

200

250

0-5 months 6-11

months

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

COVID-19 deaths

Age in years

Young children 6 months – 4 years: 

202 COVID-19 deaths

1.7% of all deaths in this age group
COVID-19 was a leading cause of death among children ages 

0 – 4 years

March 1, 2020 – April 30, 2022

Based on death certificate data from the National Center for Health Statistics. COVID-19 based on cumulative total incidence of COVID-19 deaths from March 1, 2020-April 30, 

2022.

Source: Preprint: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv

2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458

Age group Rank of COVID-19 among causes 

of death 

<1 year 4

1 – 4 years 5

5 – 9 years 5

10 – 14 years 4

15 – 19 years 4
COVID-19 is a leading cause of death among infants age 

<1 year

March 1, 2020–April 30, 2022

Based on death certificate data from the National Center for Health Statistics. COVID-19 based on cumulative total incidence of COVID-19 deaths from March 1, 2020-April 30, 

2022.

Source: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv 

2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458

Causes of Death Crude rate per 

100,000 Death (n)

1. Certain conditions originating in the perinatal period 272.1 10294

2. Congenital malformations, deformations and 

chromosomal abnormalities 113.7 4301

3. Accidents (unintentional injuries) 33.5 1266

4. Covid-19 (cumulative) 7.2 269

5. Diseases of heart 7.1 268
COVID-19 is a leading cause of death among children 

ages 1–4 years

March 1, 2020–April 30, 2022

Based on death certificate data from the National Center for Health Statistics. COVID-19 based on cumulative total incidence of COVID-19 deaths from March 1, 2020-April 30, 

2022.

Source: Flaxman S, Whittaker C, Semenova E et al. Covid-19 is a leading cause of death in children and young people ages 0-19 years in the United States. medRxiv 

2022.05.23.22275458; doi: https://doi.org/10.1101/2022.05.23.22275458

Causes of Death

Crude rate 

per 

100,000

Death (n)

1. Accidents (unintentional injuries) 7.3 1149

2. Congenital malformations, deformations and chromosomal 

abnormalities 2.6 416

3. Malignant neoplasms 1.8 285

4. Assault (homicide) 1.8 284

5. Covid-19 (cumulative) 0.9 134
Pediatric vaccine preventable diseases: Deaths per year in 

the United States prior to recommended vaccines 

1Vogt 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 Disease 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. JAMA 2007; 298:2155–63.

5 Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis. 1996 Sep;174 

Suppl 1:S5-11.

6 https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Counts-by-Age-in-Years/3apk-4u4f/data. Accessed 5/14/22 
Seroprevalence of infection-induced SARS-CoV-2 antibodies 

among children ages 6 months–17 years — National 

Commercial Lab Seroprevalence Study 

September 2021– April 2022

Shading indicates confidence intervals for each trend line.

Data updated for March/April 2022, based on Clarke K, Kim Y, Jones J et al. Pediatric Infection-Induced SARS-CoV-2 Seroprevalence Estimation Using Commercial Laboratory 

Specimens: How Representative Is It of the General U.S. Pediatric Population? (April 26, 2022). 

SSRN: https://ssrn.com/abstract=4092074 or http://dx.doi.org/10.2139/ssrn.4092074
Reinfection occurs more frequently in those previously infected 

and not vaccinated compared to infected and vaccinated 

Carazo S, Skowronski DM, Brisson M, et al. “Protection against Omicron re-infection conferred by prior heterologous SARS-CoV-2 infection, with and without mRNA vaccination” medRxiv, May 

2022. Protection against Omicron re-infection conferred by prior heterologous SARS-CoV-2 infection, with and without mRNA vaccination | medRxiv

Data on hospitalizations: Plumb ID, Feldstein LR, Barkley E, et al. Effectiveness of COVID-19 mRNA Vaccination in Preventing COVID-19–Associated Hospitalization Among Adults with Previous 

SARS-CoV-2 Infection — United States, June 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:549-555. DOI: http://dx.doi.org/10.15585/mmwr.mm7115e2

Prior infection not vaccinated

Prior infection before one vaccine dose

Prior infection before two vaccine doses

Prior infection before three vaccine doses
Improved antibody response after vaccination 

Tang J, Novak T, Hecker J, et al. “Cross-reactive immunity against the SARS-CoV-2 Omicron variant is low in pediatrics patients with prior COVID-19 or MIS-C.” Nature Communications. (2022) 

13:2979. https://doi.org/10.1038/s41467-022-30649-1

 Among children, COVID-19 vaccine induces a broader neutralizing antibody 

response compared with infection induced immunity:

– From a U.S. multicenter cohort, antibody profiles of unvaccinated pediatric patients 

hospitalized for COVID-19 were compared to profiles of vaccinated children.

– In contrast to those with SARS-CoV-2 infection, children vaccinated with two doses 

demonstrated higher titers against Alpha, Beta, Gamma, Delta and Omicron.

– The findings suggest that antibodies produced by prior SARS-CoV-2 infection (preOmicron) may not neutralize the currently circulating Omicron variant.

– This builds on evidence among adults that previous infection provides poor protection 

from infection with Omicron.

 Highlights the importance of vaccinating children with prior infection to prevent 

both severe disease and future infections. 
 COVID-19 has caused >2 million cases among children ages 6 months – 4 years

 Children 6 months–4 years of age are at risk of severe illness from COVID-19

– More than half of hospitalized children ages 6 months–4 years had no underlying conditions

– COVID-19 associated hospitalizations among children ages 6 months–4 years have similar or 

increased severity compared to older children and adolescents

– Burden of COVID-19 associated death is similar to or exceeds that of other pediatric vaccine 

preventable diseases

 Prior infection may not provide broad protection against newer SARS-CoV-2 

variants 

 COVID-19 pandemic continues to have significant impact on families

Summary

U.S. COVID-19 epidemiology in children 6 months–4 years 
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among children ages 6 months – 5 years of public health 

importance?

o No o Probably no o Probably yes o Yes o Varies o Don’t know
EtR Domain: Benefits and Harms
 Moderna COVID-19 vaccine

– GRADE summary

 Pfizer-BioNTech COVID-19 vaccine

– GRADE summary

 Other considerations 

 Number needed to vaccinate assessment

Benefits and Harms Summary
GRADE

Moderna COVID-19 vaccine: Children ages 6 months–5 years

27

 Moderna phase 2/3 randomized controlled trial in United States

 Randomized 3:1 vaccine to saline placebo

 Analyses performed separately for 6–23 months and 2–5 years, results pooled for a combined 

estimate for 6 months–5 years

 Data evaluated: all eligible randomized participants who received all vaccinations as randomized 

within the predefined window and no other important protocol deviations 

– Data cut off: Feb 21, 2022

 Per protocol, the two co-primary endpoints for immunobridging were geometric mean ratios 

(GMR) & serologic response

– Efficacy data also provided for symptomatic infection. Relative risks (RR) were calculated 

from cases in the study population. Vaccine efficacy estimates were defined as 100% x (1-RR)

• Sensitivity analyses of VE were performed to include COVID-19 cases that were 

identified using home testing lacking RT-PCR confirmation
Outcome: Symptomatic Lab-confirmed COVID-19

Moderna COVID-19 vaccine: Children ages 6 months–5 years

28

Population Events/Vaccine 

(n/N)

Events/Placebo 

(n/N)

Vaccine efficacya

(95% confidence interval)

Per protocol population

CDC case definitionb, no evidence of 

prior infection, ≥14 d post dose 2

170/4105 95/1371 40.3% (23.9% , 53.3%)

CDC case definitionb

, seropositivec or 

seronegative, ≥14 d post dose 2

181/4791 97/1597 37.8% (20.9%, 51.1%)

CDC case definitionb, sensitivity analysis 

including home tests, ≥14 d post dose 2

253/4105 133/1371 36.6% (22.4%, 48.1%)

Adult trial case definitiond ,no evidence 

of prior infection, ≥14 d post dose 2

108/4105 61/1371 40.9% (19.6%, 56.8%)

a Manufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative risk 

b Requires at least 1 prespecified clinical symptom and a positive RT-PCR

c Approximately 10% of participants were seropositive at baseline

d Requires at least 2 prespecified systemic symptoms or at least 1 respiratory symptom and a positive RT-PCR
Outcome: Symptomatic Lab-confirmed COVID-19

Moderna COVID-19 vaccine: Children ages 6 months–5 years

29

Outcome Nb GMT (model based) c

(95% CI) Nb GMT (model based) c(95% CI)

GMR (model 

based) c

(95% CI)

Met 

Noninferiority 

Objectived

6-23 Months 18-25 Years

Pseudovirus neutralizing 

antibody level by pseudovirus 

neutralizing assay (ID50)a

230 1780.7

(1606.4, 1973.8) 291 1390.8(1269.1, 1524.2) 1.28 (1.12, 1.47) Yes

2-5 Years 18-25 Years

Pseudovirus neutralizing 

antibody level by pseudovirus 

neutralizing assay (ID50)a

264 1410.0

(1273.8, 1560.8) 291 1390.8(1262.5, 1532.1) 1.01 (0.88, 1.17) Yes

Abbreviations: ID50 = 50% inhibitory dose; GLSM = geometric least squares mean; GMR = geometric mean ratio; CI=confidence interval aSampling time point was at 28 days after the second dose (day 57).

bSubjects with a negative serology test at baseline and completion of the 2-dose series on schedule. c

The log-transformed antibody levels are analyzed using an ANCOVA model with the group variable (children in P204 and young adults in P301) as fixed effect. The resulted LS means, 

difference of LS means, and 95% CI are back transformed to the original scale for presentation. 

dNoninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.

Immunobridging: Summary of Geometric Mean Ratio (GMR)
 RR 0.62 (0.49, 0.79)

 No serious concerns in certainty assessment

 Evidence type: High certainty (type 1)

GRADE: Symptomatic Laboratory-confirmed COVID-19

Moderna COVID-19 vaccine: Children ages 6 months–5 years

Assessed Using Direct Efficacy

RR= relative risk
 Ages 6–23 months

– GMR 1.28 (1.12, 1.47); non-inferiority criteria met

 Ages 2–5 years

– GMR 1.01 (0.88, 1.17); non-inferiority criteria met

 Serious concerns of indirectness because immunogenicity is a surrogate 

measure of efficacy

 Evidence type: Moderate certainty (type 2)

GRADE: Symptomatic Laboratory-confirmed COVID-19

Moderna COVID-19 vaccine: Children ages 6 months–5 years

Assessed Using Immunobridging
 Asymptomatic SAR-CoV-2 infection is identified by absence of symptoms 

AND at least 1 of following:

– Binding antibody level against SARS-CoV-2 nucleocapsid protein 

negative at Day 1 that becomes positive post-baseline. Antibody levels 

taken only on the immunogenicity subset (n=494)

– Positive RT-PCR test post-baseline at scheduled or unscheduled visit

Outcome: Asymptomatic SARS-CoV-2 infection

Moderna COVID-19 vaccine: Children ages 6 months–5 years
Outcome: Asymptomatic SARS-CoV-2 infection

Moderna COVID-19 vaccine: Children ages 6 months–5 years

Study/population Events/Vaccine 

(n/N)

Events/Placebo 

(n/N)

Vaccine Efficacya

(95% confidence interval)

bAb level against SARS-Cov 2 nucleocapsid 

protein negative at Day 1 that becomes positive 

post-baseline or positive RT-PCR test postbaseline at scheduled or unscheduled/illness 

visit without symptoms

111/4105 44/1371 16.0% (-18.5%, 40.5%)

bAb level against SARS-Cov 2 nucleocapsid 

protein negative at Day 1 that becomes positive 

post-baseline or positive RT-PCR or home 

antigen test post-baseline or where test 

modality was not identified at scheduled or 

unscheduled/illness visit without symptoms

135/4105 52/1371 21.1% (4.5%, 34.8%)

aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from 

the relative risk
 RR 0.84 (0.60, 1.19)

 Serious concerns of indirectness because asymptomatic SARS-CoV-2 PCR 

testing on the full cohort only occurred once and serology was not done 

on all participants

 Serious concerns of imprecision due to the wide confidence interval

 Evidence type: Low certainty (type 3)

GRADE: Asymptomatic SARS-CoV-2 infection

Moderna COVID-19 vaccine: Children ages 6 months–5 years

RR= relative risk
Outcome: Serious Adverse Eventsa,b,c

Moderna COVID-19 vaccine: Children ages 6 months–5 years

35

Study/populationd Events/Vaccine 

(n/N)e

% SAE

Vaccine

Events/Placebo

(n/N)e

% SAE

Placebo

Associated with 

vaccination

Moderna, unpublished 

RCT- 6-23 months

15/1761 0.85% 1/589 0.17% 1f

Moderna, unpublished 

RCT- 2-5 years

9/3031 0.30% 2/1007 0.20% 0

Moderna, unpublished 

RCT- 6 months-5 years

24/4792 0.50% 3/1596 0.19% 1f

a Serious adverse event (SAE) is defined as death, life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, persistent or 

significant incapacity or substantial disruption of the ability to conduct normal life functions, medically important event, or congenital anomaly/birth defect

b No deaths were reported in any trial participants

c Follow up through Feb 21, 2022

d Included all randomized participants who received at least 1 dose of vaccine

E Number of participants experiencing SAEs (participants may experience more than one SAE)

F One participant experienced two SAEs of fever and febrile seizure that were considered possibly related to the study intervention by FDA

RCT= randomized controlled trials
 RR 2.67 (0.80, 8.84)

 Serious concerns of indirectness due to short duration of follow up of 2 

months after dose 2

 Very serious concerns of imprecision due to the study size and width of 

the confidence interval

 Evidence type: Very low certainty (type 4)

GRADE: Serious Adverse Events

Moderna COVID-19 vaccine: Children ages 6 months–5 years

RR= relative risk
 Local reactions 

– Grade 3: 

• 6–23 months: pain at injection site preventing daily activity; injection site redness >5 cm or swelling >5 cm; axillary 

(underarm or groin) swelling or tenderness ipsilateral to injection side

• 2–5 years: pain at injection site preventing daily activity; injection site redness >10 cm or swelling >10 cm; axillary 

(underarm or groin) swelling or tenderness ipsilateral to injection side

– Grade 4: emergency room visit or hospitalization for axillary (underarm or groin) swelling or severe pain at 

the injection site, necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only)

 Systemic events 

– Grade 3: 

• ≤36 months: fever 39.6°C to 40.0°C, irritability/crying, sleepiness, or loss of appetite that prevents daily activity

• 37 months–5 years: fever 39°C to 40°C, nausea/vomiting, chills, fatigue, headache, muscle pain, or joint pain that 

prevents daily activity

– Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, or nausea/vomiting that require 

emergency room visit or hospitalization

Outcome: Reactogenicity, Severe (Grade ≥3)

Moderna COVID-19 vaccine: Children ages 6 months–5 years
Outcome: Reactogenicity, Severe (Grade ≥3)a

Moderna COVID-19 vaccine: Children ages 6 months–5 years

Study/population Events/Vaccine 

(n/N)

% Vaccine Events/Placebo

(n/N)

% Placebo

Moderna, unpublished

(either dose) 366/4774 7.7% 65/1582 4.1%

Any local (either dose) 84/4774 1.8% 6/1582 0.4%

Any systemic (either dose)b 288/4774 6.0% 59/1582 3.7%

a Reactogenicity outcome includes local and systemic events, grade ≥3 after either dose. Grade 3: prevents daily routine 

activity. Grade 4: requires emergency room visit or hospitalization. 

B There were 15 fevers of > 40.0 °C in the vaccine group and 3 in the placebo group
 RR 1.87 (1.44 to 2.42)

 No serious concerns in certainty assessment

 Evidence type: High certainty (type 1)

GRADE: Reactogenicity, Severe (Grade ≥3)

Moderna COVID-19 vaccine: Children ages 6 months–5 years

RR= relative risk
Summary of GRADE

Moderna COVID-19 vaccine: Children ages 6 months–5 years

40

OutcomeImportance Design

(# studies)

FindingsEvidence

type

Benefits

1. Symptomatic lab-confirmed 

COVID-19

Critical RCT (1) Moderna COVID-19 vaccine is effective in preventing symptomatic COVID-191

1b. Symptomatic lab-confirmed 

COVID-19 (immunobridging) Critical RCT (1) Moderna COVID-19 vaccine is effective in preventing symptomatic COVID-19

2

2. Hospitalization due to 

COVID-19

Important No studies Data not available from any studies ND

3. Multisystem inflammatory 

syndrome in children (MIS-C) Important No studies Data not available from any studies ND

4. Asymptomatic SARS-CoV-2 

infection Important RCT (1) The vaccine did not demonstrate efficacy in prevention of asymptomatic SARS-CoV-2 infection 3

Harms

5. Serious adverse eventsCritical RCT (1)

0.5% of participants with SAEs among vaccinated and 0.2% among 

unvaccinated; certainty in the estimate was very low. Two SAEs which 

occurred in one participant were judged by the investigator to be related to 

vaccination.

4

6. Reactogenicity Important RCT (1) Severe reactions were more common in vaccinated; any grade ≥3 reaction 

was reported by 7.7% of vaccinated vs. 4.1% of placebo group 1

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data
Conclusions

Moderna COVID-19 vaccine: Children ages 6 months–5 years

41

 Efficacy seen after two doses of Moderna COVID-19 vaccine in children 

ages 6 months–5 years of age consistent with real-world vaccine 

effectiveness in all other ages during Omicron predominance

 Antibody levels after 2 doses in children ages 6 months–5 years 

produces similar antibody levels after 2 doses in individuals ages 18–25 

years 

 Reactogenicity post-vaccine consistent with other recommended 

vaccines in this age group 
GRADE

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

42

 Pfizer-BioNTech phase 2/3 RCT conducted in United States, Finland, Poland, and Spain

 Randomized 2:1 vaccine to saline placebo

 Analyses performed separately for 6-23 months and 2-4 years, results pooled for a combined estimate 

for 6 months-4 years

 Interval between Dose 1 and Dose 2 of 21 days

 Interval between Dose 2 and Dose 3 varied

– Ages 6–23 months: Median interval of 16 weeks

– Ages 2–4 years: Median interval of 11 weeks

 Data evaluated: direct efficacy and immunobridging (per protocol co-primary endpoint) on all eligible 

randomized participants who received all vaccinations as randomized and no other important protocol 

deviations

– Data cut-off: April 29, 2022 median follow-up after dose 3: 1.3 months

– Relative risks (RR) were calculated from cases in the study population. Vaccine efficacy estimates 

were defined as 100% x (1-RR)

RCT= randomized controlled trial
GRADE

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

43

Population 

6 months–4 years

Vaccine 

n (%)

Placebo 

n (%)

Total 

n (%)

Randomized population 3013 (100%) 1513 (100%) 4526 (100%)

Dose 1 3013 (100%) 1513 (100%) 4526 (100%)

Dose 2 2985 (99.1%) 1503 (99.3%) 4488 (99.2%)

Dose 3 992 (32.9%) 464 (30.7%) 1456 (32.2%)
Population Events/Vaccine 

(n/N)

Events/Placebo 

(n/N)

Vaccine efficacya

(95% confidence interval)

Evaluable efficacyb

With or withoutc evidence of prior 

infection (≥7 d post Dose 3), 

ages 6–23 months

1/386 2/184 76.2 (-161.2, 97.8)

With or withoutc evidence of prior 

infection (≥7 d post Dose 3), 

ages 2–4 years

2/606 5/280 81.5 (5.3, 96.4)

With or withoutcevidence of prior 

infection (≥7 d post Dose 3),

ages 6mo–4 years

3/992 7/464 80.0 (22.8, 94.8)

Outcome: Symptomatic Lab-confirmed COVID-19

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

44

aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative risk

bAll eligible randomized participants who received all vaccinations as randomized and had no other important protocol deviations as 

determined by the investigator

c

Approximately 30% of participants were seropositive at baseline
Outcome: Symptomatic Lab-confirmed COVID-19

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

45

Immunobridging: Summary of Geometric Mean Ratio (GMR)

nc GMTd

(95% CI) nc GMTd(95% CI)

GMRe

(95% CI)

Met 

Noninferiority 

Objectivef

6–23 months (3 doses, 3 μg) 16–25 years (2 doses, 30 μg)

SARS-CoV-2 neutralization 

assay – NT50a,b 82 1406.5

(1211.3, 1633.1) 170 1180.0(1066.6, 1305.4)

1.19

(1.00, 1.43) Yes

2–4 years (3 doses, 3 μg) 16–25 years (2 doses,30 μg)

SARS-CoV-2 neutralization 

assay – NT50a,b 143 1535.2

(1388.2, 1697.8) 170 1180.0 (1066.6, 1305.4)

1.30

(1.13, 1.50) Yes

Abbreviations: NT50 = 50% neutralizing titer; GMT = geometric mean titer; GMR = geometric mean ratio; LLOQ = lower limit of quantitation aAmong participants who had no serological or virological evidence (1-month post-Dose 2 [16-25 years] or 1-month post-Dose 3 [6 mo – 4 years]) of past SARS-CoV-2 infection and had negative NAAT at any unscheduled visit up to one 

month after dose two.

bSampling time point was one month after dose two. c

Number of subjects with valid and determinate assay results for the specified assay at the given dose and sampling time point.

dGMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 LLOQ. eGMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1a [6 to 23 months] or Group 1b [2 to 4 years] – Group 2 [16–25 years]) and the corresponding CI (based on the 

Student t distribution).

f

Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
Outcome: Symptomatic Lab-confirmed COVID-19, dose 2 efficacy 

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

46

Population Events/Vaccine 

(n/N)

Events/Placebo 

(n/N)

Vaccine efficacya

(95% confidence interval)

6–23 months

With or without evidence of prior 

infection, ≥7 Days after Dose 2 to 

before Dose 3, ages 6–23 monthsb

80/1178 48/598 15.4 (-19.4, 40.0)

2–4 years

With or without evidence of prior 

infection, ≥7 Days after Dose 2 to 

before Dose 3, ages 2–4 yearsc

100/1835 74/915 32.6 (10.0, 49.6)

aManufacturer vaccine efficacy estimates calculated using incidence rates. For GRADE, vaccine efficacy calculated from the relative 

risk

bMet non-inferiority criteria for immunobridging to 16–25-year-olds

c

Did not meet non-inferiority criteria for immunobridging to 16–25-year-olds 
 RR 0.2 (0.05, 0.77)

 Serious concern for indirectness due to the short duration of follow-up 

of 1.3 months

 Very serious concerns for imprecision due to study size

 Evidence type: Very low certainty (type 4)

GRADE: Symptomatic Laboratory-confirmed COVID-19

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

Assessed Using Direct Efficacy

RR= relative risk
 Ages 6–23 months

– GMR 1.19 (1.00, 1.43); non-inferiority criteria met

 Ages 2–4 years 

– GMR 1.30 (1.13, 1.50); non-inferiority criteria met

 Serious concerns of indirectness because immunogenicity is a surrogate 

measure of efficacy

 Evidence type: Moderate certainty (type 2)

GRADE: Symptomatic Laboratory-confirmed COVID-19

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

Assessed Using Immunobridging
Outcome: Serious Adverse Events

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

49

 Safety population, approximately 1700 ages 6–23 months

– Included all randomized participants who received at least 1 dose of vaccine* 

– Data from Dose 1 to data cutoff date (April 29, 2022); Median follow-up after dose 3: 

1.3 months 

 Safety population, approximately 2700 ages 2–4 years 

– Included all randomized participants who received at least 1 dose of vaccine* 

– Data from Dose 1 to data cutoff date (April 29, 2022); Median follow-up after dose 3: 

1.4 months

*Six participants in 6-23 months age group and 9 participants in 2 to 4 years age group excluded due to not receiving vaccine or placebo.
Outcome: Serious Adverse Eventsa,b

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

50

Study/populationc Events/Vaccine 

(nd/N)

% SAE

Vaccine

Events/Placebo

(nd/N)

% SAE

Placebo

Associated with 

vaccination

Pfizer/BioNTech RCT

Ages 6 – 23 months 

17/1178e 1.4 14/598f 2.3 0

Pfizer/BioNTech RCT

Ages 2 – 4 years 

12/1835g 0.7 8/915h 0.9 1i

Pfizer/BioNTech RCT 

Ages 6 months – 4 years 

29/3013 1.0 22/1504 1.5 1

a Serious adverse event (SAE) is defined as any untoward medical occurrence that, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, 

results in persistent disability/incapacity, or is a congenital anomaly/birth defect. SAEs after dose 1 or dose 2 or dose 3 are reported. 

bNo deaths were reported in any trial participants c Included all randomized participants who received at least 1 dose of vaccine.

d Number of participants experiencing SAEs (participants may experience more than one SAE), data cutoff 29 April 2022.

e Twenty-two SAEs were reported in 17 vaccine recipients ages 6 to 23 months.

f Eighteen SAEs occurred in 14 placebo recipients ages 6 to 23 months. 

g Fifteen SAEs were reported in 12 vaccine recipients ages 2 to 4 years. 

hEight SAEs occurred in 8 placebo recipients ages 2 to 4 years.

i One vaccine recipient had 2 SAEs (fever and pain in extremity requiring hospitalization) considered possibly related by the Investigator. FDA considered the events potentially consistent with 

symptoms due to unspecified viral infection 
 RR 0.66 (0.38, 1.15) 

 Very serious concern for indirectness due to the short duration of 

follow-up of 1 month post dose 3 and because only 31% of trial 

participants received dose 3, limiting the ability to detect serious 

adverse events that occur at a higher rate after dose 3

 Serious concerns of imprecision due to the study size

 Evidence type: Very low certainty (type 4)

GRADE: Serious Adverse Events

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

RR= relative risk
 All ages: Local reactions (redness, swelling, pain/tenderness at injection site)

– Grade 3: pain at injection site that prevents daily activity; redness >7 cm; and swelling >7 cm

– Grade 4: emergency room visit or hospitalization for severe pain at the injection site, necrosis (redness and 

swelling categories) or exfoliative dermatitis (redness category only)

 Ages 6–23 months: Systemic events (fever, decreased appetite, drowsiness, irritability)

– Grade 3: fever >38.9°C to 40.0°C or events that prevent daily activity

– Grade 4: fever >40.0°C or events that require emergency room visit or hospitalization

 Ages 2–4 years: Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or 

worsened muscle pain, new or worsened joint pain)

– Grade 3: fever >38.9°C to 40.0°C , vomiting that requires IV hydration; diarrhea of ≥6 loose stools in 24 hours; 

severe fatigue, severe headache, severe muscle pain, or severe joint pain that prevents daily activity

– Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, diarrhea, or vomiting that require emergency 

room visit or hospitalization

Outcome: Reactogenicity, Severe (Grade ≥3)

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years
Outcome: Reactogenicity, Severe (Grade ≥3)a

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

Study/population Events/Vaccine 

(n/N)

% Vaccine Events/Placebo

(n/N)

% Placebo

Pfizer-BioNTech, 

unpublished (any dose) 129/3010 4.3% 54/1510 3.6%

Any local (any dose) 4/3010 0.1% 3/1510 0.2%

Any systemic (any dose)b 125/3010 4.2% 52/1510 3.4%

Note: Grade 3: prevents daily routine activity. Grade 4: requires emergency room visit or hospitalization

a Reactogenicity outcome includes local and systemic events, grade ≥3 after either dose. 

b Six fevers of > 40.0 °C were reported among vaccine recipients and one among placebo recipients 
 RR 1.20 (0.88, 1.64)

 Serious concern for indirectness was noted because only 31% of trial 

participants received dose 3 limiting the ability to detect severe 

reactogenicity that occurs specifically after dose 3

 Evidence type: 2 (moderate certainty)

GRADE: Reactogenicity (Grade ≥3)

Pfizer COVID-19 vaccine: Children ages 6 months–4 years
Summary of GRADE

Pfizer COVID-19 vaccine: Children ages 6 months–4 years

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data 55

OutcomeImportance Design

(# studies)

FindingsEvidence

type

Benefits

1a. Symptomatic lab-confirmed 

COVID-19 (efficacy) Critical RCT (1) Pfizer-BioNTech COVID-19 vaccine is effective in preventing symptomatic COVID-19; certainty in the estimate was very low 4

1b. Symptomatic lab-confirmed 

COVID-19 (immunobridging) Critical RCT (1) Pfizer-BioNTech COVID-19 vaccine is effective in preventing symptomatic COVID-19

2

2. Hospitalization due to 

COVID-19

Important No studies Data not available from any studies ND

3. Multisystem inflammatory 

syndrome in children (MIS-C) Important No studies Data not available from any studies ND

4. Asymptomatic SARS-CoV-2 

infection Important No studies Data not available from any studies ND

Harms

5. Serious adverse eventsCritical RCT (1)

1.0% of participants with SAEs among vaccinated and 1.5% among 

unvaccinated; certainty in the estimate was very low. 2 SAEs in 1 participant 

in the vaccine arm were judged to be related to vaccination.

4

6. Reactogenicity Important RCT (1) Severe reactions were slightly more common in vaccinated; any grade ≥3 

reaction was reported by 4.3% of vaccinated vs. 3.6% of placebo group 2
Conclusions

Pfizer-BioNTech COVID-19 vaccine: Children ages 6 months–4 years

56

 Antibody levels after 3 doses in children ages 6 months–4 years produces 

similar antibody levels after 2 doses in individuals ages 16–24 years 

 Reactogenicity post-vaccine similar after each of the 3 vaccine doses, and 

similar to reactions seen in placebo recipients

 Efficacy estimates difficult to interpret given small numbers and limited 

follow-up time

– Impact of longer interval in the trial between dose 2 and dose 3 on efficacy, 

reactogenicity or safety are unknown
Other considerations for mRNA COVID-19 vaccines in young children 

57

 COVID-19 vaccines and seropositivity

 Myocarditis in young children

 Cardiac complications after SARS-CoV-2 infections 

 Vaccine-associated myocarditis in children and adolescents

 Numbers needed to vaccinate analysis
COVID-19 vaccines and seropositivity

 Omicron-wave surges of pediatric COVID-19 hospitalizations occurred even with high 

seroprevalence, suggesting this alone is not sufficient to provide broad protection

 Many seropositive individuals vaccinated without concerns

 Vaccination remains the safest strategy for preventing complications from SARSCoV-2 infection and offers additional protection against re-infection 

– Prior infection may not provide broad protection against newer SARS-CoV-2 variants 

 Clinical Considerations states that people who recently had SARS-CoV-2 infection 

may consider delaying their COVID-19 vaccine by 3 months after infection

– An increased time between infection and vaccination may result in an improved immune 

response to vaccination

– Low risk of reinfection has been observed in the weeks to months following infection 
Myocarditis in young children

Background rates

59

LOS = Length of hospital stay 

Vasudeva et al. Am J Cardiology 2021 https://www.sciencedirect.com/science/article/pii/S0002914921002617

Previously presented: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/02-COVID-Oster-508.pdf

 Before the COVID-19 pandemic, peaks in 

myocarditis hospitalizations seen in 

infants and adolescents

– In adolescents, typically viral in etiology

– In infants, many cases can represent 

cardiomyopathy with genetic component
Cardiac complications due to SARS-CoV-2 in young children

1 60 MIS-C National Surveillance Data, provided by Multisystem Inflammatory Syndrome Unit, Epidemiology & Surveillance Task Force, CDC

 Cardiac complications in the setting of acute SARS-CoV-2 infection in young 

children are uncommon

 Most cardiac complications post-SARS-CoV-2 infection in infants related to 

MIS-C

– 1.8% of MIS-C cases are children ages 6-11 months1

– Infants <1 year of age with MIS-C have severe cardiovascular involvement in 

~55-65% of cases1
61

VAERS reporting rates of myocarditis (per 1 million doses administered) 

after mRNA COVID-19 vaccination, days 0–7 and 8–21 post-vaccination*,†

* As of May 26, 2022; reports verified to meet case definition by provider interview or medical record review; primary series and 1st booster doses only

† An estimated 1–10 cases of myocarditis per 100,000 person years occurs among people in the United States, regardless of vaccination status; adjusted for days 0–7 and 8–21 risk intervals, this 

estimated background is 0.2 to 2.2 per 1 million person-day 0–7 risk interval and 0.4 to 3.8 per 1 million person-day 8–21 risk interval (peach shaded cells indicate that reporting rate exceeded 

estimated background incidence for the period)

0–7 days 8–21 days 0–7 days 8–21 days

Males Males Females Females

Age (yrs) Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster Dose 1 Dose 2 Booster

5–11 0.2 2.6 0.0 0.6 0.0 0.0 0.2 0.7 0.0 0.2 0.0 0.0

12–15 5.3 46.4 15.3 1.2 1.2 0.9 0.7 4.1 0.0 0.4 0.2 0.9

16–17 7.2 75.9 24.1 1.7 3.2 1.3 0.0 7.5 0.0 0.7 0.4 0.0

18–24 4.2 38.9 9.9 1.1 2.2 0.4 0.6 4.0 0.6 0.2 0.7 0.0

25–29 1.8 15.2 4.8 0.4 1.1 0.5 0.4 3.5 2.0 0.2 0.0 0.8

30–39 1.9 7.5 1.8 0.4 0.8 0.2 0.6 0.9 0.6 0.3 0.2 0.0

40–49 0.5 3.3 0.4 0.2 0.5 0.0 0.4 1.6 0.6 0.2 0.2 0.0

50–64 0.5 0.7 0.4 0.2 0.3 0.1 0.6 0.5 0.1 0.2 0.5 0.1

65+ 0.2 0.3 0.6 0.3 0.2 0.1 0.1 0.5 0.1 0.1 0.2 0.1

PfizerBioNTech

PfizerBioNTech 

and 

Moderna
Vaccine-associated myocarditis in young children

62

 Risk of myocarditis after mRNA COVID-19 vaccination, if any, in young 

children is unknown

– No cases occurred during clinical trials (n=7,804 with at least 7 days of follow-up)

 Based on the epidemiology of classic myocarditis and safety monitoring in 

children ages 5-11 years, myocarditis after mRNA COVID-19 vaccination in 

young children is anticipated to be rare

– Underlying epidemiology of myocarditis fundamentally different in infants

– Dose used in young children lower than dose used in older children 
Post-authorization vaccine effectiveness

Overcoming COVID-19 platform

No. vaccinated COVID-19 

patients/Total COVID-19 

patients (%)

Adjusted VE

% (95% CI)

5–11 years* 25/325 (8) 68 (48-81)

12–18 years 109/286 (38) 51 (31-65)

2–22 weeks since vaccination 42/219 (19) 58 (34-74)

23–45 weeks since vaccination 67/244 (27) 42 (14-61)

-20 0 20 40 60 80 100

2 doses of Pfizer-BioNTech vaccine against hospitalization, Dec 19, 2021-Apr 27, 2022

2 doses of Pfizer-BioNTech vaccine against MIS-C, Jul 1, 2021-Apr 7, 2022

No. vaccinated MIS-C

patients/Total no.

MIS-C patients (%)

Median (IQR)

days from 2nd

dose to MIS-C

Adjusted VE

(95% CI)

5–11 years 10/144 (7) 44 (32-56) 78 (48-90)

12–18 years 14/160 (9) 120 (57-169) 90 (81-95)

28-120 days since vaccination 7/153 (5) 60 (42-89) 90 (75-96)

≥121 days since vaccination 7/131 (5) 172 (138-215) 92 (78-97)

0 20 40 60 80 100

Vaccine Effectiveness (%)

*median time from vaccination to hospitalization is 37 days
Methods for calculation of number needed to vaccinate

64

Benefits — Calculated per 1 million fully vaccinated with mRNA vaccine

 Age group: 6 months – 4 years

 Pandemic average age-specific incidence rates

– Hospitalization rates: COVID-NET1

– Case rates: Case based surveillance2

 Assumed VE against hospitalization: 42-84%3

 Assumed VE against symptomatic infection: 30%-60%4

 Time Horizon: 120-day period

VE: Vaccine Effectiveness

1https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html

2 Used rates in children ages 1-4 years because ages in months was not available: https://covid.cdc.gov/covid-data-tracker/#demographicsovertime

3Based on the ratio of infection to severe disease seen in 5–11-year-olds applied to the VE against infection seen in 6 months – 4 years

4Based on VE seen in pediatric clinical trials 
Number of children ages 6 months – 4 years needed to 

vaccinate to prevent 1 infection or 1 hospitalization over 

120 days

6,150 -12,300 vaccinations needed to prevent 1 hospitalization 

Calculated using pandemic average rates 

670 – 1,300 vaccinations needed to prevent 1 case

Assumptions: Benefits accrue over 120 days; Data Sources: COVID-Net https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. 
Number of children ages 6 months – 4 years needed to 

vaccinate to prevent 1 hospitalization: COVID-19 vs. influenza 

over 6 months

1,660 - 3,320 

vaccinations needed to 

prevent 1 hospitalization 

COVID-19

Assumptions: Benefits accrue over 6 months; Data Sources: Influenza number needed to vaccinate: Pediatrics. 2007 Sep;120(3):467-72. doi: 

10.1542/peds.2007-0167; COVID-Net hospitalization rates from 10/1/2021-4/30/2022: https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. 

Influenza

1,030 - 6,890 

vaccinations needed to 

prevent 1 hospitalization 
Summary

Known and potential benefits

67

 Clinical trials provide data for protection against symptomatic infection 

 Clinical trials were not powered to detect efficacy against severe disease in 

young children, but similar patterns expected to what is seen in everyone 

ages 5 years and over, with higher protection against severe disease 

 Emerging data in adults suggest that post-COVID conditions may be less 

likely to occur in vaccinated individuals 

 Vaccination in this age group may also provide parents with increased 

confidence to return to pre-pandemic activities, improving social 

interactions in young children 
Summary

Known and potential harms

68

 Clinical trials provide safety data in nearly 8,000 vaccinated young children

 Post-authorization safety data after almost 600 million doses of COVID-19 

vaccines given in the United States 

 Post-authorization safety data for children ages 5-11 years very reassuring: 

reporting rates of myocarditis in males only slightly elevated compared to 

background incidence 

– Likely related to both underlying epidemiology of myocarditis and dose de-escalation 
Benefits and Harms: Summary of the Available Evidence 

69

 First COVID-19 vaccine clinical trials conducted exclusively during Omicron 

predominance

– Post-authorization vaccine effectiveness studies with lower VE in Omicron, compared 

to previous SARS-CoV-2 variants

 Both mRNA COVID-19 vaccines for young children met non-inferiority 

criteria for neutralizing antibody levels 

– Differences in certainty of efficacy estimates for each mRNA vaccine; cannot directly 

compare estimates

 Receipt of a primary COVID-19 vaccine series can provide protection 

against COVID-19 disease and severe outcomes

 Benefits of COVID-19 vaccines in young children outweigh possible risks
Benefits and Harms

How substantial are the desirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is a desirable effect?

o Minimal o Small o Moderate o Large o Varies o Don’t know
Benefits and Harms

How substantial are the undesirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is an undesirable effect?

o Minimal o Small o Moderate o Large o Varies o Don’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 (Moderna COVID-19 vaccine)

oFavors comparison (no vaccine)

oFavors both

oFavors neither

oUnclear
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 (Pfizer-BioNTech COVID-19 vaccine)

oFavors comparison (no vaccine)

oFavors both

oFavors neither

oUnclear
EtR Domain: Values
 Survey designed to assess parental beliefs and attitudes toward pediatric COVID-19 

vaccinations among children ages 6 months – 4 years 

 Data collection period: February 2 – February 10, 2022

 Final sample (N = 2,048)

Survey of parental attitudes and intentions toward pediatric 

COVID-19 and recommended vaccinations 

CDC and University of Iowa/RAND survey, unpublished 

Targeted percentages 49.9% Child Ages 6 – 23 months

50.2% Child Ages 2 – 4 years 

51.1% Female

48.1% Male

0.8% Transgender or Other 

Gender Identity

34.2% Non-Hispanic White

32.8% Non-Hispanic Black

33.0% Hispanic

CHILD AGE GROUP GENDER RARACE/ETHNICITY
Half of the parents of children ages 6 months – 4 years said 

they ‘definitely’ or ‘probably’ would vaccinate their child, 

once they become eligible 

CDC and University of Iowa/RAND survey, unpublished 

‘Definitely’ or 

‘Probably’ will

vaccinate

Unsure

‘Definitely’ or 

‘Probably’ will not

vaccinate 
A third of parents of children ages 6 months – 4 years said 

they ‘definitely’ or ‘probably’ would not vaccinate their 

child, once eligible 

CDC and University of Iowa/RAND survey, unpublished 

‘Definitely’ or 

‘Probably’ would

vaccinate

Unsure

‘Definitely’ or 

‘Probably’ would not

vaccinate 
Only a fifth of all respondents said they would get their child ages 6 

months – 4 years vaccinated within 3 months after becoming eligible 

CDC and University of Iowa/RAND survey, unpublished 

19.6%

21.0%

25.5%

30.1%

3.8%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Under 3 months

3–6 months

Over 6 months

Don’t know

Refuse to answer

% of respondents who selected the response option (n=2,048)
Preference for a 2-dose or 3-dose series

CDC and University of Iowa/RAND survey, unpublished 

No preference

20%

3-dose series sooner

20%

2-dose series later

28%

Not vaccinating

32%
 Percentage of parents of children ages 6 months – 4 years who ‘definitely’ 

or ‘probably’ will vaccinate their child when eligible significantly varied by:

–Gender of parent

• 51% males vs. 44% females 

–Race and Ethnicity

• 53% Hispanic/Latino vs. 46% NH Black and 43% NH White

–Education

• 60% ≥ Bachelor’s degree, 40% Some college/Trade school and 42% ≤ High school degree

Impact of demographics on pediatric vaccination intentions

CDC and University of Iowa/RAND survey, unpublished 
Parental intent for vaccination of children 6 months – 4 years, 

National Immunization Survey-Child COVID Module (NIS-CCM), December 2021 – May 2022

 The NIS-CCM is a random-digitdial cellular telephone survey of 

households with children that 

began on July 22, 2021

 In May, one-third (33.5%) of 

parents report they definitely will 

get their child 6 months–4 years 

vaccinated

 17.2% of parents report they 

definitely will not get their child 

vaccinated

May: Interviews May 1-28, 2022, n=3465; April: Interviews March 27–April 30, 2022, n=4,063; March: Interviews February 27–March 26, 2022, n=3,626 ; February: Interviews January 

30–February 26, 2022, n=3,231 ;January: Interviews January 2–29, 2022, n=3,221; December: Interviews November 28 – December 31, 2021, n=1,313

NIS-CCM estimates (5-17 years) available on COVIDVaxView at: https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html

41.3

39.6

37.2

36.5

33.6

33.5

18.0

18.5

16.1

16.3

17.1

19.6

16.1

17.7

18.9

18.8

19.6

19.4

7.3

9.1

9.0

9.2

9.2

10.1

17.1

14.9

18.6

19.0

20.2

17.2

0 20 40 60 80 100

December

January

February

March

April

May

Definitely will get child vaccinated Probably will get child vaccinated

Unsure if will get child vaccinated Probably will NOT get child vaccinated

Definitely will NOT get child vaccinated
Parental intent for vaccination of children 6 months – 4 years, 

National Immunization Survey-Child COVID Module (NIS-CCM) , May 2022

 In May, a smaller percentage 

(29.6%) of parents of children 

6–23 months reported definite 

intent to vaccinate their child 

compared to parents of 

children 2–4 years (35.4%)

 There was no difference in the 

percentage reporting 

definite/probably will not get 

child vaccinated

35.4

29.6

37.1

42.9

27.2

27.5

0 20 40 60 80 100

2-4 years

6-23 months

Definitely will get child vaccinated

Probably/Unsure will get child vaccinated

Definitely/probably will NOT get child vaccinated

May: Interviews May 1-28, 2022, n=3465

NIS-CCM estimates (5-17 years) available on COVIDVaxView at: https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html
 Survey respondents were asked, “Thinking about your child under the age of 5, once 

there is a COVID-19 vaccine authorized and available for your child’s age group, do 

you think you will...?”

One in five parents of children under five will vaccinate their 

child right away once available, but most remain more cautious 

KFF COVID-19 Vaccine Monitor. https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/#parents Accessed May 25, 2022

20%

23%

31%

21%

18%

40%

33%

29%

26%

38%

10%

7%

12%

15%

11%

30%

35%

26%

35%

27%

July '21

Sept '21

Jan '22

Feb '22

April '22

Get them vaccinated right away Wait and see Only if required Definitely not
 Survey respondents were asked, “Do you feel you have enough information about 

the safety and effectiveness of the COVID-19 vaccine for...?

Most parents say they don’t have enough information about 

COVID-19 vaccine safety and effectiveness for children under 5

KFF COVID-19 Vaccine Monitor: April 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2022 Accessed May 25, 2022

*Survey conducted prior to safety and efficacy information available on COVID-19 vaccines in young children 
 Half of parents of children ages 6 months through 4 years definitely or 

probably would vaccinate their child, once eligible

– However, nearly a third of parents of children ages 6 months through 4 years definitely or 

probably would not vaccinate their child, once eligible

 One in five parents of children under 5 (18%) are eager to vaccinate their child 

and plan to do so right away once a COVID-19 vaccine is authorized for their 

child’s age group, but many others remain more cautious

 In a survey conducted prior to available data on COVID-19 vaccines in young 

children, many parents of children under five say they don’t have 

enough information about the safety and effectiveness of COVID-19 vaccines 

for children in this age group (56%)

Values: Summary of the Available Evidence 
Values

Criteria 1:

Does the target population feel that the desirable effects are large relative to 

undesirable effects?

• How does the target population view the balance of desirable versus undesirable 

effects? 

• Would parents/caregivers feel that the benefits outweigh the harms and burden?

• Does the population appreciate and value the Pfizer-BioNTech & Moderna COVID-19 

vaccine?

o Minimal o Small o Moderate o Large o Varies o Don’t know
Values 

oImportant uncertainty or variability

oProbably important uncertainty or variability

oProbably not important uncertainty or variability

oNo important uncertainty or variability

oNo known undesirable outcomes

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?
EtR Domain: Acceptability
 Percent of parents who say they trust each of the following a great deal or a fair 

amount to provide reliable information about the COVID-19 vaccines for children:

Pediatricians are top trusted source of child vaccine 

information for parents across community types 

KFF COVID-19 Vaccine Monitor: Winter Update on Parents’ Views (November 8-23, 2021). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccinemonitor-vaccine-attitudes-rural-suburban-urban/ Accessed March 7, 2022
 As of early May 2022, more than two-thirds of Vaccines For Children 

(VFC) program providers were enrolled as COVID-19 vaccine providers

 For young children, encouraging VFC providers to enroll as COVID-19 

vaccine providers and encouraging enrolled providers to administer the 

COVID-19 vaccine becomes even more critical to ensure access to 

COVID-19 vaccine as well as all other routine childhood vaccines

Vaccines for Children (VFC) program and COVID-19

CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 years old and/or COVID-19 

Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022
 Continued coordination through jurisdictions will be needed for the Indian 

Health Service (IHS), Tribal and Urban Indian Health Programs, and Health 

Resources and Services Administration (HRSA) programs

 Similar to the COVID-19 vaccine rollout for 5–11-year-olds, jurisdictions should 

plan their ordering strategy and identify priority locations to vaccinate 

children ages 6 months – 4 years or 6 months – 5 years

 The goal is an efficient rollout resulting in equitable vaccine access for young 

children in the initial weeks when demand is likely to be higher

Additional jurisdiction coordination for COVID-19 

vaccination among children

CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 years old and/or COVID-19 

Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022
Possible Network of Providers for Children ages <5 years

~18,000 nonpharmacy 

providers that 

have administered 

the 5-11 vaccine

~4,000 pharmacies 

that have 

expressed interest 

in administering 

vaccine to children 

<5 years

~85% of children <5 

years live within 5 

miles of a vaccine 

provider
 A child’s health care provider is the top trusted source of child vaccine 

information for parents across community types 

 As of early May 2022, more than two-thirds of Vaccines For Children 

(VFC) program providers were enrolled as COVID-19 vaccine providers

 Continued coordination through jurisdictions and identifying priority 

locations to vaccinate young children will facilitate efficient rollout 

resulting in equitable vaccine access for this age group 

 Nearly all young children will live within 5 miles of a vaccine provider for 

COVID-19 vaccines

Acceptability: Summary of the Available Evidence 
Acceptability

Are mRNA COVID-19 vaccines acceptable to key stakeholders?

• Are there key stakeholders that would not accept the distribution of benefits 

and harms?

• Are there key stakeholders that would not accept the undesirable effects in 

the short term for the desirable effects (benefits) in the future?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Feasibility
 The Moderna vaccine for children 

ages 6 months – 5 years: 

– Ships at -20°C

– Different color border (magenta)

– Different concentration than adult 

primary series (25μg/0.25mL) 

– New national drug code (NDC)

– Does not require diluent

Moderna COVID-19 vaccine product for children ages 6 

months – 5 years 

CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19 

Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022

Age Group 6 months through 5 years 

(Primary Series)

6 years through 11 years 

(Primary Series)

Currently unavailable

(Use the vial with dark blue 

cap and a label with a purple 

border)

6 years through 11 years

(Primary Series) 

12 years and older 

(Primary Series)

18 years and older

(Booster Dose)

18 years and older

(Booster Dose)

Vial Cap Color Dark Blue Dark Blue Dark Blue Red

Vial Label Border 

Color MAGENTA TEAL PURPLE LIGHT BLUE

Vial Image

Primary Dose 

Volume 0.25 mL 0.5 mL 0.5 mL 0.5 mL

Booster Dose 

Volume None None 0.5 mL 0.25 mL

 

 

 

Moderna COVID-19 Vaccine Products
 The Pfizer-BioNTech vaccine for 

children ages 6 months – 4 years: 

– Ships at -80°C 

– Different color cap (maroon)

– Different amount of diluent added 

(2.2mL)

– New national drug code (NDC)1

Pfizer-BioNTech COVID-19 vaccine product for children ages 

6 months – 4 years 

1. CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or 

COVID-19 Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022

2. CDC. Pfizer-BioNTech COVID-19 Vaccine Products. https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-Reference-Planning.pdf Accessed June 16, 2022

Pfizer-BioNTech COVID-19 Vaccine Products2
 The packaging configuration for both vaccine products is 10-dose vials in 

cartons of 10 vials each (100 doses total) with a minimum order quantity 

of 100 doses per product

 Ancillary supplies will be provided for both vaccine products, including 

1- inch needles and syringes to support 100 doses of vaccine

– Diluent will be provided with ancillary supplies to support 100 doses per kit for the 

Pfizer vaccine

Packaging configuration and ancillary supplies for PfizerBioNTech and Moderna COVID-19 vaccines for children 

CDC. Updated Pediatric COVID-19 Vaccination Operational Planning Guide – Information for the COVID-19 Vaccine for Children 6 Months through 4 Years Old and/or COVID-19 

Vaccine for Children 6 Months through 5 Years Old. https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf Accessed June 1, 2022
 Pfizer-BioNTech vaccine for children ages 6 months–4 years

– Similar product configuration to other Pfizer-BioNTech pediatric products, but with a 

maroon cap

– May be more familiar to pediatric healthcare providers 

– Long term storage requires an ultra-low temp (-80oF freezer)

– Requires diluent

 Moderna vaccine for children ages 6 months–5 years 

– May be less familiar to pediatric healthcare providers

– Product able to be stored at traditional freezer temperatures

– Does not require diluent

Feasibility: Summary of the Available Evidence 
Feasibility

Is the Moderna COVID-19 vaccine feasible to implement among 

children ages 6 months – 5 years?

• Is the Moderna COVID-19 vaccine program sustainable?

• Are there barriers that are likely to limit the feasibility of implementing the 

Moderna COVID-19 vaccine or require considerations when implementing it? 

• Is access to Moderna COVID-19 vaccine an important concern?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
Feasibility

Is the Pfizer-BioNTech COVID-19 vaccine feasible to implement 

among children ages 6 months – 4 years?

• Is the Pfizer-BioNTech COVID-19 vaccine program sustainable?

• Are there barriers that are likely to limit the feasibility of implementing the 

Pfizer-BioNTech COVID-19 vaccine or require considerations when 

implementing it? 

• Is access to Pfizer-BioNTech COVID-19 vaccine an important concern?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Resource Use
 No studies were found that evaluated cost-effectiveness of COVID-19 

vaccination among children

 Studies in adults have shown COVID-19 related healthcare costs could be billions or 

trillions of dollars1,2. Given this, COVID-19 vaccines overall are likely cost-saving3-5. 

 In a study conducted by Pfizer, they estimated that Pfizer-BioNTech COVID-19 vaccine 

use in individuals ages ≥12 years in 2021 averted 9 million symptomatic cases, almost 

700,000 hospitalizations and over 110,00 deaths resulting in $30.4 billion direct 

healthcare cost savings6

 At this time, vaccine will be available at no cost to the recipient

 Cost-effectiveness not a primary driver for decision making during a pandemic, but 

will be reassessed in the future 

Resource Use: Review of the available evidence

1 Bartsch et al https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00426 2 Cutler and Summers. JAMA https://jamanetwork.com/journals/jama/fullarticle/2771764

3 Bartsch et al. JID https://academic.oup.com/jid/article/224/6/938/6267841?login=true 4 Kohli et al. Vaccine https://www.sciencedirect.com/science/article/pii/S0264410X2031690X

5 Li et al. Int JID https://www.sciencedirect.com/science/article/pii/S1201971222001680

6 Di Fusco et al Full article: Public health impact of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in the first year of rollout in the United States (tandfonline.com)
Resource Use

Are mRNA COVID-19 vaccines among children ages 6 months – 5 

years a reasonable and efficient allocation of resources?

• What is the cost-effectiveness of mRNA COVID-19 vaccines?

• How does the cost-effectiveness of mRNA COVID-19 vaccines change in 

response to changes in context, assumptions, etc.?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Equity
0

100

200

300

400

500

600

700

Mar

20'

April

20'

May

20'

Jun

20'

Jul

20'

Aug

20'

Sept

20'

Oct

20'

Nov

20'

Dec

20'

Jan

21'

Feb

21'

Mar

21'

Apr

21'

May

21'

Jun

21'

Jul

21'

Aug

21'

Sept

21'

Oct

21'

Nov

21'

Dec

21'

Jan

22'

Feb

22'

Mar

22'

Apr

22'

May

22'

Children ages 0 – 4 years

American Indian/Alaska Native, NH Asian/Pacific Islander, NH Black, NH Hispanic White, NH

COVID-19 weekly cases per 100,000 population by race and 

ethnicity and age group, United States

March 1, 2020 – May 28, 2022

NH = Non-Hispanic

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime Accessed May 31, 2022
Parental intent for vaccination of children 6 months – 4 years, 

National Immunization Survey-Child COVID Module (NIS-CCM) , May 2022

By Receipt of Influenza Vaccination since July 1

By Race/Ethnicity By Metropolitan Statistical Area

By Household Income/Poverty Level

May: Interviews May 1-28, 2022, n=3465

NIS-CCM estimates (5-17 years) available on COVIDVaxView at: https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive.html

47.0

34.9

30.3

26.8

37.1

33.5

40.9

48.0

14.9

31.4

28.8

25.1

0 20 40 60 80 100

Other/Multiple

White

Black

Hispanic

27.1

19.2

25.5

45.9

41.9

43.4

46.3

31.7

30.7

36.8

28.2

22.3

0 20 40 60 80 100

Not reported

Below Poverty

 < $75k/year

>= $75k/year

20.2

35.3

35.6

37.7

39.0

39.3

42.1

25.6

24.6

0 20 40 60 80 100

Rural

Suburban

Urban

41.8

17.7

41.1

34.0

16.9

48.3

0 20 40 60 80 100

Received Flu Vax

No Flu Vax
 Focus Group Details

– 18 focus groups with 4-6 participants in each group

– Varied demographics of parents including Black, Hispanic/Latino, and Overall 

population 

– Some groups composed of parents ‘Ready to Vaccinate’ others ‘Waiting to Vaccinate’

 Format

– COVID-19 Context, Attitudes, and Behaviors

• Participants share thoughts and opinions about the COVID-19 pandemic regarding their child

– Vaccination intent

• Participants share thoughts and opinions about getting their child a COVID-19 vaccine when 

it is authorized and available

Vaccination intentions of parents of children under 5

HHS/ASPA Focus Groups, COVID-19 Public Education Campaign

CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data
Parents of children ages 6 months – under 2 years

CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data

Black parents 

• Noted that child’s pediatrician did not have a strong stance on receiving a COVID-19 vaccine, despite having a strong 

stance on vaccines in general – making them second guess whether the COVID vaccine is necessary for kids 

• Young children can’t talk/say what’s going on or how they feel, contributing to concerns about vaccinating kids

• The only thing that will make them trust is time

•

Hispanic/Latino parents

• Want to wait a couple of months perhaps; but want the pediatrician to specifically advise it

• Some parents have talked to their doctor about the options and didn’t get a strong recommendation

• If things get worse, that will motivate them to vaccinate their child – like higher cases, worse scenario 

Overall population 

• Clinical trial data – how many children didn’t get COVID after being vaccinated, how many didn’t get symptoms

• Complication rate – how many complications per set amount of children

• Lots of mixed information on COVID vaccines for children under 5 – they don’t know who to believe 
Black parents 

• COVID is such a new virus, they are still learning about it 

• Long term side effects are the big concern –child will be living a long time, want to know that they are safe 

• One person admits that they make an intentional choice to NOT pay attention to the news/get information on 

COVID because it will make them worry too much 

Hispanic/Latino parents

• One parent feels like COVID is so new that the information medical professionals have might not be totally right

• One parent would get their young child vaccinated right away based on the experience from themselves and other 

child – a smaller dose makes them more comfortable 

• One parent would rather not get for their child unless they had to – questions need based on case counts 

Overall population 

• Want to know about the efficacy – to see if it’s worth it or not

• Waiting until there is a requirement and mandate

• Parents know the vaccines made them feel bad (short-term side effects) – so they don’t want their kids to suffer the 

same side effects 

Parents of children ages 2 years – 4 years

CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data
 Parents personal experience with COVID (for themselves and for their children) 

informs how they view the importance of the vaccine

– If their children already had COVID, and it was mild, they aren’t worried about immediately 

vaccinating

– If they or their child had severe COVID, they are more amenable to getting vaccinated to avoid that 

experience from recurring

 Pervasive idea that kids are not at high risk of getting COVID or having severe 

outcomes from COVID

 Time is a major barrier for most parents

– Time the vaccines have been in production

– Myth of the vaccines being rushed

– Others mention wanting time for their children to grow and develop

– Many parents mention taking time after approval to see how things go for other people before 

making a final decision

Major themes of vaccination intentions among parents of 

children under 5 years 

CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data
 CDC, doctors are trusted sources for providing information regarding vaccination and 

COVID-19

– Some participants have been told mixed information by providers about whether to vaccinate their 

children under 5 years of age

 Parents want to discuss both pros and cons of vaccination and avoid messages that are 

overly simplistic or positive

– Incorporate more information into communications that provide reassurance about possible side effects 

 Ads need to include imagery that is representative of the specific age group

– Include diversity in racial and ethnic groups, gender, parents (moms and dads should be shown) 

 Public health and clinical trial research must be inclusive of historically marginalized 

populations, from before research initiation through completion and dissemination

What can be done to improve vaccination intention among 

parents of children under 5 years 

CDC/NCIRD, VTF Research Team, HHS/ASPA COVID-19 Public Education Campaign, Unpublished data
 Pediatricians are often the providers who vaccinate children, and many do this 

through the federally funded Vaccines for Children (VFC) program

– However, pediatricians are not the only providers who can vaccinate children

 In many areas, pharmacies and community clinics – such as Federally Qualified 

Health Centers, rural health clinics, and community health centers also administer 

vaccines for children, and some of these are also VFC providers

 Many schools and school districts partner with health departments, pharmacies, 

other healthcare providers and trusted community representatives to hold vaccine 

clinics in schools to vaccinate children who may not otherwise have access

 Community organizations, including faith-based organizations, can serve as 

vaccination sites or as informational resources to help families find community-based 

vaccination sites

What communities can do to improve equity in childhood 

vaccination

CDC Vaccines and Immunizations. Equity in Childhood COVID-19 Vaccination. https://www.cdc.gov/vaccines/covid-19/planning/children/equity.html Accessed June 1, 2022
Equity

What would be the impact of mRNA COVID-19 vaccines in young 

children on health equity?

• Are there groups or settings that might be disadvantaged in relation to COVID19 disease burden or receipt of mRNA COVID-19 vaccines?

• Are there considerations that should be made when implementing the mRNA

COVID-19 vaccine program to ensure that inequities are reduced whenever 

possible, and that they are not increased?

oReduced oProbably reduced oProbably no impact

oProbably increased oIncreased oVaries o Don’t know
Summary
116

EtR DomainQuestion

Work Group Judgments

Public Health 

Problem

Is COVID-19 disease among children ages 6 months – 5 years of public health 

importance?

Yes

Benefits and 

Harms

How substantial are the desirable anticipated effects? Large

How substantial are the undesirable anticipated effects? Small

Do the desirable effects outweigh the undesirable effects (Moderna)? Favors intervention

Doe the desirable effects outweigh the undesirable effects (Pfizer)? Favors intervention 

Values

Does the target population feel the desirable effects are large relative to the 

undesirable effects?

Varies

Is there important variability in how patients value the outcomes? Probably important uncertainty or 

variability 

Acceptability

Are mRNA vaccines acceptable to key stakeholders?Yes

Feasibility

Is the Moderna COVID-19 vaccine feasible to implement among children 

ages 6 months – 5 years?

Yes

Is the Pfizer-BioNTech COVID-19 vaccine feasible to implement among 

children ages 6 months – 4 years? Probably yes

Resource Use

Are mRNA COVID-19 vaccines among children ages 6 months – 5 years a 

reasonable and efficient allocation of resources?

Yes

Equity

What would be the impact of mRNA COVID-19 vaccines in young children on 

health equity?

Probably no impact 
 Work Group discussed each mRNA COVID-19 vaccine primary series 

compared to no vaccine 

 Both mRNA COVID-19 vaccine primary series in young children met the 

non-inferiority endpoints, provide protection against symptomatic 

COVID-19 disease, and are expected to provide higher protection against 

severe disease

 Two vaccine options in this population may allow parents and providers 

a choice, which may increase uptake and acceptability

Work Group Interpretation
118

Evidence to Recommendations Framework

Summary: Work Group Interpretations (Moderna)

Balance of 

consequences

Undesirable 

consequences 

clearly 

outweigh 

desirable 

consequences 

in most 

settings

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences 

in most 

settings

The balance 

between 

desirable and 

undesirable 

consequences 

is closely 

balanced or 

uncertain

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences 

in most 

settings

Desirable 

consequences 

clearly 

outweigh 

undesirable 

consequences 

in most 

settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

Two doses of 25μg Moderna COVID-19 vaccine
119

Evidence to Recommendations Framework

Summary: Work Group Interpretations (Moderna)

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 

Two doses of 25μg Moderna COVID-19 vaccine
120

Evidence to Recommendations Framework

Summary: Work Group Interpretations (Pfizer-BioNTech)

Balance of 

consequences

Undesirable 

consequences 

clearly 

outweigh 

desirable 

consequences 

in most 

settings

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences 

in most 

settings

The balance 

between 

desirable and 

undesirable 

consequences 

is closely 

balanced or 

uncertain

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences 

in most 

settings

Desirable 

consequences 

clearly 

outweigh 

undesirable 

consequences 

in most 

settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

Three doses of 3μg Pfizer-BioNTech COVID-19 vaccine
121

Evidence to Recommendations Framework

Summary: Work Group Interpretations (Pfizer-BioNTech)

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 

Three doses of 3μg Pfizer-BioNTech COVID-19 vaccine
 Since the beginning of the COVID-19 pandemic, among U.S. children ages 

6 months – 4 years of age, there have been 

Over 2 million cases

Over 20,000 hospitalizations

Over 200 deaths

 COVID-19 can cause severe disease and death among children, including 

children without underlying medical conditions

 Future surges will continue to impact children, with unvaccinated children 

remaining at higher risk of severe outcomes

Summary
 As with all other age groups, priority is vaccination of unvaccinated 

individuals 

 Expansion of vaccine recommendations down to children 6 months of 

age would allow 18.7 million children to receive primary COVID-19 

vaccine series 

Summary
Children who are NOT moderately or severely immunocompromised

Pfizer-BioNTech

(6 months–4 years)

Moderna

(6 months–5 years)

Dose 1

(primary)

Dose 2 

(primary)

Dose 3 

(primary)

At least

8 weeks 3-8 weeks

Dose 1

(primary)

Dose 2 

(primary)

4-8 weeks

Children who ARE moderately or severely immunocompromised

Pfizer-BioNTech

(6 months–4 years) Dose 1

(primary)

Dose 2 

(primary)

Dose 3 

(primary)

At least

3 weeks 8 weeks

Moderna

(6 months–5 years) Dose 1

(primary)

Dose 2 

(primary)

4 weeks

Dose 3 

(primary)

At least 

4 weeks
 Current data are for a 2-dose (Moderna) or 3-dose (Pfizer-BioNTech) 

primary series 

 Post-authorization effectiveness studies can help determine subsequent 

timing and need of boosters

– Immunocompromised children may also need additional doses for optimal protection

Summary
 As with all ages, post-authorization safety and effectiveness monitoring 

will be critical 

 Platforms are in place to monitor vaccine effectiveness; results will be 

communicated publicly as soon as possible

– Timing will depend on vaccine uptake, as well as COVID-19 incidence 

 COVID-19 vaccines are being administered under the most intensive vaccine 

safety effort in U.S. history 

Continued monitoring is critical
Smartphone-based safety monitoring for COVID-19 vaccines

• A parent must be registered with v-safe in order to 

add a child to their account

• If a parent is already registered, they can access their 

account to add a child

• To register or access your account go to 

https://vsafe.cdc.gov/en/

161

v-safe is a CDC smartphone-based monitoring program for COVID-19 vaccine safety in the U.S.
v-safe uses text messages and web surveys to check in

• Parents complete surveys on behalf of their child

• Surveys solicit how the child feels after COVID-19 

vaccination

– Local injection site reactions (i.e., pain, redness, swelling)

– Systemic reactions (i.e., fatigue, headache, joint pain)

– Health impacts (unable to perform normal daily activities, 

missed school or work, or received care) 

• Surveys have specific questions for young, non-verbal 

children
Promoting v-safe in practice– we need help!

How:

• Direct patients to https://vsafe.cdc.gov/en/

– Ideally this should occur before vaccination

• Provide v-safe information sheet to patients

• Display posters about v-safe 

https://www.cdc.gov/coronavirus/2019ncov/vaccines/safety/vsafe/printresources.html
Questions to ACIP 

 Should vaccination with Moderna COVID-19 vaccine (2-doses, 25μg, IM) 

be recommended for persons 6 months – 5 years of age, under an 

Emergency Use Authorization?

 Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3μg, IM) 

be recommended for children 6 months – 4 years of age, under an 

Emergency Use Authorization?
 Monica Godfrey

 Katherine Fleming-Dutra

 Megan Wallace

 Danielle Moulia

 Lauren Roper

 Elisha Hall

 Sarah Meyer

 Evelyn Twentyman

 Ruth Link-Gelles

 Tara Anderson

 Amy Blain

 Mary Chamberland

 Susan Goldstein

 Stephen Hadler 

 Valerie Morelli

 Hannah Rosenblum

 Sierra Scarbrough

 Eddie Shanley

 JoEllen Wolicki

 Megan Lindley 

 Tammy Santibanez

 VTF ACIP WG Team

 ACIP COVID-19 Vaccines Work Group

 Vaccine Task Force

 Epi Task Force

 Data Analytics and Visualization Task Force

 Respiratory Viruses Branch

 MIS-C unit

 CICP TF’s Monitoring and Evaluation 

Acknowledgments
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.