cdc.gov/coronavirus

EtR Framework:

Pfizer-BioNTech COVID-19 vaccine in 

children aged 5–11 years

Sara Oliver MD, MSPH

ACIP Meeting

November 2, 2021
Evidence to Recommendations (EtR) Framework

 Should vaccination with Pfizer-BioNTech COVID-19 vaccine 

(2-doses, 10μg, IM) be recommended for children 5–11 years 

of age, under an Emergency Use Authorization?

Evidence to Recommendations (EtR) Framework

Policy Question
Population Children aged 5–11 years

Intervention Pfizer-BioNTech COVID-19 vaccine (BNT162b2)

(2-doses, 10μg, 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

PICO Question
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?

“The intervention” = Pfizer-BioNTech COVID-19 vaccine, given to children aged 5–11 years

“The problem” = COVID-19 among children aged 5–11 years
EtR Domain: Public Health Problem
Trends in number of COVID-19 cases in the United States

January 22, 2020 – October 29, 2021

Cases: 45,846,153

https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
Summary

SARS-COV-2 epidemiology in children aged 5–11 years

 Children are at least as likely to be infected with SARS-CoV-2 as adults

– Over 1.9 million reported cases; seroprevalence estimated ~38% among 5–11 years in Sept 2021

– Infections in children less likely to be reported as cases than infections in adults

 Children 5-11 years of age are at risk of severe illness from COVID-19

– >8,300 COVID-19 related hospitalizations as of mid-October

– Cumulative hospitalization rate is similar to pre-pandemic influenza seasons

– Severity comparable among children hospitalized with influenza and COVID-19, with 

approximately 1/3 of children 5–11 years requiring ICU admission

– MIS-C most frequent among children 5–11 years

– Post-COVID conditions have been reported in children

 Secondary transmission from young school-aged children occurs in household and 

school settings
Other pediatric vaccine preventable diseases: 

Hospitalizations per year prior to recommended vaccines 

1 https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm

2Meyer 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 3https://www.cdc.gov/flu/weekly/weeklyarchives2007-2008/07-08summary.htm 

Hepatitis A1 Varicella2

(Chickenpox) Influenza3 COVID-19

Age 5–14 years <20 years 5–17 years 5–11 years

Time period 2005 1988–1995 2003–2007 Oct 2020–Oct 2021

Hospitalization 

Burden

(per 100,000 population) <1 4-31 30-80 25
Other vaccine preventable diseases: 

Deaths per year 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. JAMA2007; 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.

Hepatitis A1 Meningococcal 

(ACWY)2 Varicella3 Rubella4 Rotavirus5 COVID-19

Age <20 years 11–18 years 5–9 years All ages <5 years 5–11 years

Time 

period 1990–1995 2000–2004 1990–1994 1966–1968 1985–1991 Oct 2020–

Oct 2021

Average 

deaths 

per year 3 8 16 17 20 66
Modeling the impact of COVID-19 vaccination in children 

ages 5–11 years

https://covid19scenariomodelinghub.org/

 Vaccination among 5–11-year-olds is expected to accelerate the decline in 

cases, reducing cumulative incidence nationally by an expected 8%

(~600,000 cases) from November 2021 to March 2022

 Vaccination of 5–11-year-olds would dampen, but not eliminate, a new 

variant emergence
COVID-19 Related K-12 School Closures by State, 

August 2, 2021 – October 22, 2021

School 

districts 

closed

Total # 

schools 

closed*

Estimated 

# students 

affected*

Estimated 

# teachers 

affected*

313 2,351 1,217,777 78,134

Data from the Unplanned School Closure Monitoring Project (DGMQ/CDC), ongoing research that uses systematic daily media searches (methods explained in 

https://doi.org/10.1371/journal.pone.0248925).

* Number of schools closed in district-wide closures, total number of students, and total number of teachers are estimated by matching the public school district ID or 

school ID with the district/school data for school year 2019/20 and private school ID with school data for year 2017/18 as obtained from the National Center for 

Education Statistics (https://nces.ed.gov/ccd/elsi/tableGenerator.aspx, accessed on Apr 20, 2021). Due to missing information in 2019/20 data, the total number of 

public school teachers in California is estimated using 2018/19 NCES data.
- Worsening of mental or emotional health

- Widening of existing education gaps

- Decreased physical activity and increased body mass index (BMI)

- Decreased healthcare utilization

- Decreased routine immunizations

- Increase in Adverse Childhood Experiences (ACEs)

- Loss of caregivers

Indirect impacts of COVID-19 pandemic on children
Public health problem:

Summary of the available evidence

 Children 5–11 years of age are at risk of severe illness from COVID-19

– Over 1.9 million reported cases and >8,300 hospitalizations through mid-October

• Cumulative hospitalization rate similar to influenza season

• MIS-C most frequent among children 5–11 years

– Other post-COVID conditions have been seen in children

 COVID-19 in children leads to missed school for themselves and their 

communities

 Wide use of an effective vaccine would reduce public health burden of 

COVID-19 in children 5–11 years of age
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among children aged 5–11 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
Benefits and harms assessments

 GRADE

 Potential benefits and harms in seropositive children

 Potential risk of myocarditis

GRADE= Grading of Recommendations, Assessment, Development and Evaluation
17

PICO question and evidence review

Population Children aged 5–11 years

Intervention Pfizer-BioNTech COVID-19 vaccine (BNT162b2)

(10 μg, 2 doses IM, 21 days apart)

Comparison No vaccine

Outcomes 1. Symptomatic lab-confirmed COVID-19

2. Hospitalization due to COVID-19

3. Multisystem inflammatory syndrome in children (MIS-C) 

4. Asymptomatic SARS-CoV-2 infection

5. Serious adverse events

6. Reactogenicity

 Evidence review identified 1 clinical trial for inclusion
Outcome #1: Symptomatic lab-confirmed COVID-19

18

 Pfizer-BioNTech COVID-19 vaccine phase 2/3 randomized controlled trial (RCT)* 

 Randomized 2:1 vaccine to placebo (median follow-up time: 3.3 months) 

 Vaccine efficacy against symptomatic lab-confirmed COVID-19 was 90.9% 

(95% CI: 68.3%, 98.3%) 

– 3 cases in the vaccine arm (N=1461; surveillance time: 369 person-years) 

– 16 cases in the placebo arm (N=714; surveillance time: 179-person-years)

 The geometric mean ratio (GMR) for antibodies in 5–11-year-olds compared with 

16–25-year-olds was 1.04 (95% CI:0.93, 1.18), and met the noninferiority criteria

*Unpublished, data obtained from sponsor
Evidence table: Outcome #1: Symptomatic lab-confirmed COVID-19

19

Certainty assessment No of patients Effect

No of Certainty Importance

studies

Study 

design

Risk of 

bias Inconsistency Indirectness Imprecision Other 

considerations Intervention Comparison

Relative

(95% CI)

Absolute

(95% CI)

Vaccine efficacy against symptomatic COVID-19

1 RCT Not 

serious a

Not 

serious

Not 

serious b,c

Not 

serious

None 3/1461d

(0.2%)

16/714e

(2.2%)

RR 0.10

(0.03 to 

0.31)

2,017 fewer 

per 100,000 

(from 2,174 

fewer to 

1,546 fewer)

Type 1 CRITICAL

CI: Confidence interval; RR: Risk ratio

a Exclusions from evaluable efficacy population occurred in 5.1% of the BNT162b2 group and 2.8% of the placebo group (due to receipt of dose 2 outside of protocol 

defined window of 19-42 days after dose 1 or other important protocol deviations). This was deemed not serious.

b Indirectness was considered because the vaccine efficacy observed at a median 3-month follow-up may differ from that observed over a longer period of time. 

However, this was deemed not serious.

c The RCT excluded children who were immunocompromised or had a prior history of MIS-C. The population included in the RCT may not represent all persons aged 5-

11 years. However, this was deemed not serious.

d Total surveillance time was 369 person-years e Total surveillance time was 179 person-years
Outcome #5: Serious adverse events (SAE)

20

 Pfizer-BioNTech phase 2/3 randomized controlled trial (RCT)* 

 None of the SAEs were assessed by the investigator as related to study intervention. 

 No deaths were reported in any trial participants

 Initial Enrollment Group (median follow-up time: 3.3 months)

1 SAEs in 1 participants in the vaccine group (n=1518) 

– Limb fracture

 Safety Expansion Group (median follow-up time: 2.4 weeks)

3 SAEs in 3 participants in the vaccine group (n=1591)

– Infective arthritis (infection of the knee)

– Foreign body ingestion of a penny

– Epiphysial fracture

2 SAEs in 1 in the placebo group (n=750)

– Pancreatitis 

– Abdominal pain

0 SAEs in the placebo group (n=788)

*Unpublished, data obtained from sponsor; randomized 2:1 vaccine to placebo
Evidence table: Outcome #5: Serious adverse events

21

aSerious concern of indirectness was noted. The body of evidence does not provide certainty that rare serious adverse events were captured due to the short duration of follow-up 

(median: 3.3 months).

bThe effects noted are from an analysis of the initial enrollment group population. A safety expansion group of children aged 5–11 years, 1591 children in the vaccine arm and 788 

children in the placebo arm, were not included because of the short duration of follow-up (median: 2.4 weeks). At the time of the data cutoff (October 8, 2021) 3 SAEs (arthritis infective 

[infection of the knee], foreign body ingestion of a penny, epiphyseal fracture) were reported in 3 children (1 each) in the vaccine group. The pooled relative risks for the initial 

enrollment group and safety expansion group was 1.98 (95% CI: 0.22, 17.70). All SAEs were assessed by the investigator as not related to the study intervention. c

Very serious concern for imprecision was noted based on the 95% confidence interval crossing the line of no effect (1). The width of the confidence interval contains estimates for which 

different policy decisions might be considered. This outcome may be imprecise due to the small number of events during the observation period. d1 SAE (limb fracture) was reported in a participant in the BNT162b2 group, which was determined by the investigator to be unrelated to the study intervention. All SAEs were assessed by 

the investigator as not related to the study intervention.

e2 SAEs (pancreatitis and abdominal pain) occurred in 1 placebo recipient.

Certainty assessment No of patients Effect

Certainty Importance No of 

studies

Study 

design Risk of 

bias Inconsistency Indirectness Imprecision

Other 

considerations Intervention Comparison Relative

(95% CI)

Absolute 

(95% CI)

Serious adverse events

1 RCT Not 

serious

Not serious Seriousa, b Very 

Seriousc

None 1/1518d

(0.07%)

1/750e

(0.1%)

0.49 

(0.03,7.89)

68 fewer 

per 

100,000 

(from 129 

fewer to 

919 more)

Type 4 CRITICAL
Outcome #6: Reactogenicity, severe (grade ≥3)

22

 Pfizer phase 2/3 randomized controlled trial (RCT)* solicited events from participants or 

reported by their parent/legal guardian through electronic diaries for 7 days following 

each dose

 Local reactions (redness, swelling, pain at the injection site) and systemic reactions 

(fever, nausea/vomiting, headache, fatigue, chills, new or worsened muscle pain, new or 

worsened joint pain) were reported for 7 days after each dose 

– 2.7% of children in the vaccine arm vs 1.1% in the placebo arm had a local or system grade ≥ 3 

reaction after either dose 

• Most reactions were grade 3; 1 child in the vaccine arm with had a grade 4 fever >40.0°C; 

there were no other grade 4 reactions 

– More common after Dose 2; pain at injection site, fatigue and headache were the most common

*Unpublished, data obtained from sponsor
Evidence table: Outcome #6: Reactogenicity, severe (Grade ≥3)

23

Certainty assessment No of patients Effect

Certainty No of Importance

studies Study 

design Risk of bias Inconsistency Indirectness

Imprecisio

n

Other 

conside

rations

Interventio

n Comparison Relative(95% CI)

Absolute 

(95% CI)

Reactogenicity, severe (grade ≥3)

1 RCT Not 

serious

Not 

serious

Not 

Serious

Seriousa None 41/1517 

(2.7%)

8/750 

(1.1%)

RR 2.53

(1.19 to 

5.38)

1,632 more 

per 100,000 

(from 203 

more to 

4,672 more)

Type 2 IMPORTANT

a Serious concern for imprecision given the wide 95% confidence interval, which cannot exclude the possibility of no difference between 

BNT162b2 and placebo.
Conclusion 

GRADE: Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years

 Phase 2/3 RCT conducted among children aged 5–11 years

 >3,000 children were vaccinated with BNT162b2 

 Vaccine efficacy estimate of 90.9% for prevention of symptomatic laboratoryconfirmed COVID-19 (high certainty)

 Serious adverse events were uncommon among vaccine and placebo participants 

(0.07% vs 0.1%). No SAEs were judged to be related to vaccination and no deaths 

occurred (very low certainty).

 Grade ≥3 local or systemic reactions were more common among vaccine than 

placebo recipients and were reported by 2.7% of vaccine participants (moderate 

certainty).
Benefits and harms assessments

 GRADE

 Potential benefits and harms in seropositive children

 Potential risk of myocarditis

GRADE= Grading of Recommendations, Assessment, Development and Evaluation
Immune response by serostatus

 Geometric mean titers (GMT) were higher in those with prior infection

 Geometric mean fold rise (GMFR) was less (likely due to higher GMTs initially)

Baseline 

SARS-CoV-2 

status

N (%)

Geometric Mean Titers

(GMT)

Geometric Mean Fold Rises 

(GMFR)

GMT 

pre-dose 1 

(95% CI)

GMT 1 month 

post dose 2 

(95% CI)

GMFR 

(95% CI)

Positive 21 (7%) 59.8 

(33.5, 106.5)

3270.0 

(2032.1, 5261.8)

54.7 

(35.3, 84.7)

Negative 273 (93%) 10.1

(9.9, 10.3)

1211.3 

(1121.1, 1308.7)

119.6 

(110.8, 129.2)
Summary 

COVID-19 vaccines and seropositivity

 ~9% of children in clinical trial were baseline SARS-CoV-2 seropositive

 Post-vaccination antibodies higher in children who were baseline seropositive

 Rates of local and systemic reactions, as well as adverse events, were lower in children 

who were baseline seropositive

 Approximately 38% of children aged 5–11 years have evidence of prior SARS-CoV-2 

infection based on seroprevalence estimates

 Prior infection can result in protection against infection but not 100% and likely 

decreases over time

 Children have a greater proportion of asymptomatic infection relative to adults1-4

– Asymptomatic infection can result in lower antibody levels than severe disease

1. Viner RM, Ward JL, Hudson LD, et al. [published online ahead of print, 2020 Dec 17]. Arch Dis Child. 2020;archdischild-2020-320972

2. Irfan O, Muttalib F, Tang K, Jiang L, Lassi ZS, Bhutta Z. [published online ahead of print, 2021 Feb 16]. Arch Dis Child. 2021;106(5):440-448

3. Dawood FS, Porucznik CA, Veguilla V, et al. [published online ahead of print, 2021 Oct 8]. JAMA Pediatr. 2021;10.1001/jamapediatrics.2021.4217. doi:10.1001/jamapediatrics.2021.4217

4. Poline J, Gaschignard J, Leblanc C, et al.. Clin Infect Dis. 2021;72(12):2215-2217. doi:10.1093/cid/ciaa1044

Data from Phase 3 clinical trial

Data from U.S. studies 
Balance of benefits and risks by seropositive status

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

seroprevalence ~38%, suggesting this alone is not sufficient to provide broad protection

 Limited data on rates of reinfection in children

 Protection against asymptomatic/mild infection important outcome in children

– MIS-C typically occurs after asymptomatic or mild infection; post-COVID conditions can also occur 

after mild infection

 No concerns identified in safety surveillance with seropositive adolescents and adults

– Individuals 12-64 years with seropositivity >30%

 Vaccine recommendations that require serologic testing place unnecessary barriers

 Limited data to estimate impact of vaccination of seropositive children, but risks minimal

 Balance of benefits and risks favorable for vaccination of all children
Vaccine-associated myocarditis

 Identified rates of myocarditis are based on data from adolescents and adults 

receiving 30ug dose of Pfizer-BioNTech COVID-19 vaccine

– Dose in pediatric (5–11-year-old) age group: 10ug dose 

 Rare event, but most common in males 12–29 years of age

 No cases of myocarditis occurred during the clinical trials with 5–11-year-olds

– N=3,082 with at least 7 days of follow up reported
Benefits and risks of Pfizer-BioNTech COVID-19 vaccine 

for children 5–11 years of age

Benefits

Pfizer-BioNTech COVID-19 

vaccine for children 

5–11 years of age

Risks

Pfizer-BioNTech COVID-19 

vaccine for children 5–11 

years of age
31

57,301 COVID-19 cases prevented

60 ICU admissions prevented

130 MIS-C cases prevented

Estimated benefits for every million Pfizer-BioNTech COVID-19 

vaccinations in children 5-11 years of age using recent incidence 

Females 5-11 years Males 5-11 years

226 hospitalizations prevented

56,954 COVID-19 cases prevented

130 MIS-C cases prevented

72 ICU admissions prevented

191 hospitalizations prevented

Assumptions: Benefits accrue over 180 days (6 months); VE against symptomatic COVID-19: 90%; VE against hospitalization: 95% 

Data Sources: COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic. COVID Data Tracker https://covid.cdc.gov/coviddata-tracker/#trends_dailycases. COVID-Net https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. All data are from the week ending on 9/11/2021.
32

58,204 COVID-19 cases prevented

72 ICU admissions prevented

42 MIS-C cases prevented

Estimated benefits for every million Pfizer-BioNTech COVID-19 vaccinations 

in children 5-11 years of age using pandemic-average incidence 

Recent Epidemiology

5-11 years

80 hospitalizations prevented

18,549 COVID-19 cases prevented

132 MIS-C cases prevented

26 ICU admissions prevented

226 hospitalizations prevented

Pandemic Average

5-11 years

Assumptions: Benefits accrue over 180 days (6 months); VE against symptomatic COVID-19: 90%; VE against hospitalization: 95% 

Data Sources: COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic. COVID Data Tracker https://covid.cdc.gov/covid-datatracker/#trends_dailycases. COVID-Net https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html. 

Recent epidemiology data from the week ending on 9/11/2021. Pandemic average data are averaged for the entire pandemic through the week ending on 10/16/2021.
33

Estimated risks for every million Pfizer-BioNTech COVID-19 

vaccinations in children 5-11 years of age

Rates of myocarditis after vaccination in 5–11-year-olds unknown

No cases occurred during clinical trials (n=3,082 with at least 7 days follow-up)

Myocarditis after vaccination in 5–11-year-old population likely lower than 

rates seen in 12–15-year-olds 

Underlying epidemiology of viral myocarditis varies greatly between children aged 

_____5–11 and 12–17 years: substantially lower in children 5–11 years of age

Dose used in 5–11-year-olds (10μg) is a third of dose used in 12–15-year-olds (30μg)
34

Estimated rates of myocarditis after vaccination in 

adolescents 12–15 years of age, per million second doses

Females Males Total

VAERS 3.9 39.9 21.5

VSD 12.1 108.5 60.2

VAERS rates as of Oct 6th; VSD rates as of Oct 23rd. Both show risk after second dose, per million doses 
Benefits and risks of Pfizer-BioNTech COVID-19 vaccine 

for children 5–11 years of age

35

Benefits Risks

Prevention of COVID-19 cases 

Likely prevention of 

hospitalizations, MIS-C and deaths 

and post-COVID conditions

Possible prevention of 

transmission

Greater confidence in safer return 

to school and social interactions 

Myocarditis or other rare 

events after mRNA 

vaccines?

Short-term reactogenicity
Number of children aged 5-11 years needed to vaccinate to 

prevent symptomatic COVID-19, hospitalization, and MIS-C

Assumptions: VE against symptomatic COVID-19: 90%; VE against hospitalization: 95%. Estimated over 180 days (6 months); 

Data Sources: COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic October, 24, 2021; COVID Data Tracker https://covid.cdc.gov/coviddata-tracker/#trends_dailycases. October, 24, 2021; COVID-Net October, 24, 2021, https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html

9

2213

3777

26

8187

11226

0

2000

4000

6000

8000

10000

12000

NNV to prevent 1

COVID-19 case

NNV to prevent 1

COVID-19

hospitalization

NNV to prevent 1

MIS-C case

Number Need to Vaccinate
Benefits and Harms

Summary

 Clinical trial demonstrated Pfizer-BioNTech COVID-19 vaccine is safe, 

__immunogenic and efficacious in children 5–11 years of age

– Trial not powered to assess rate of rare adverse events; no cases of myocarditis in 

~3100 vaccinated children 

 Balance of benefits and risks varies by incidence of COVID-19

– Largest benefits with higher incidence 

 Benefit/risk balance favorable, regardless of seropositivity rates

– While many children 5–11 years of age may be seropositive, unknown duration of 

protection for asymptomatic infection in children

– Safety data reassuring in seropositive population 
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?

o Favors intervention (Pfizer-BioNTech COVID-19 vaccine)

o Favors comparison (no vaccine)

o Favors both

o Favors neither

o Unclear
EtR Domain: Values
 Among parents surveyed, 34–57% plan to get their children vaccinated1-6

 90% of parents ‘very worried’ their child would get COVID-19 reported intent to 

vaccinate their child, compared to 7% of parents ‘not worried at all’5

 82% of fully vaccinated parents reported intent to vaccinate their child, 

compared to 1% of parents who are unvaccinated/do not plan to get vaccinated5

 Among parents of teens who discussed vaccination with their pediatrician, 

three-quarters of those whose pediatrician recommended vaccination say their 

child received at least 1 dose6

1. Szilagyi PG, et al. Parents' Intentions and Perceptions About COVID-19 Vaccination for Their Children: Results From a National Survey [published online ahead of print, 2021 Aug 3]. Pediatrics. 2021;e2021052335. 

2. Ruggiero KM, et al. Parents' Intentions to Vaccinate Their Children Against COVID-19 [published online ahead of print, 2021 Jun 30]. J Pediatr Health Care.

3. Brenan M. In U.S., 55% Would Get COVID-19 Vaccine for Young Child. Gallup. September 28, 2021. Available at: https://news.gallup.com/poll/354998/covid-vaccine-young-child.aspx . Accessed October 1, 2021

4. Unpublished data from the CDC, the University of Iowa, and RAND Corporation Survey of Parents, September 2021

5. Gallup Panel Poll. Available at https://news.gallup.com/poll/354998/covid-vaccine-young-child.aspx. Accessed September 29, 2021.

6. Lopes L, et al. KFF COVID-19 Vaccine Monitor: Available at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-trends-among-children-school/ Accessed: October 1, 2021

Parental surveys 

Intent to have children vaccinated
Parental surveys 

Intent to have child vaccinated varies by age and race/ethnicity

Szilagyi PG, et al. Parents' Intentions and Perceptions About COVID-19 Vaccination for Their Children: Results From a National Survey [published online ahead of print, 2021 Aug 3]. Pediatrics. 2021;e2021052335. 
44.9%

35.3%

34.4%

31.1%

28.0%

24.3%

16.2%

13.5%

12.7%

9.7%

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

Long term side effects

Short term side effects

Wait and see if safe

Allergic reaction

Myocarditis or pericarditis

Don’t trust vaccine

Unsure if vaccine will work

Child does not need vaccine

Fear of needles

COVID-19 is not a threat

Unpublished data from the CDC, the University of Iowa, and RAND Corporation Survey of Parents, September 2021

Parental surveys 

Survey of 1000 U.S. parents of children aged 5-11, September 2021 

Concerns of parents who did 

not indicate they would 

“definitely get”

child vaccinated 

(n=842)

57% of parents surveyed stated they would “definitely” (35%) or “probably” (22%) 

get their child vaccinated 
62.3%

51.3%

47.9%

44.1%

43.3%

41.7%

40.1%

39.8%

36.6%

32.6%

30.5%

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

Allergic reaction

Fever

Myocarditis or pericarditis

Sinus venous thrombosis

Headache

Guillain-Barre syndrome

Getting COVID-19

Infertility

GI issues

Pain at injection site

Fainting

Unpublished data from the CDC, the University of Iowa, and RAND Corporation Survey of Parents, September 2021

Parental surveys 

Survey of 1000 U.S. parents of children aged 5-11, September 2021 

37% of parents reported side effects as reason for not wanting COVID-19 vaccine 

for their child
Values

Summary

 Among several polls of U.S. parents, about half of parents say they are likely 

to get their child vaccinated

 Many parents cite concerns for long- or short-term side effects such as fever, 

anaphylaxis or myocarditis in their decision to vaccinate their child

 Other factors that influence a parents’ decision to vaccinate include the 

parents’ vaccination status and provider recommendation
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 patients/caregivers feel that the benefits outweigh the harms and burden?

• Does the population appreciate and value the Pfizer-BioNTech COVID-19 vaccine?

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

o Important uncertainty or variability

o Probably important uncertainty or variability

o Probably not important uncertainty or variability

o No important uncertainty or variability

o No 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
Acceptability

 As of October 15, >70% of Vaccines For Children (VFC) providers were 

enrolled as COVID-19 providers

– >70% of VFC providers represent >80% of VFC vaccine that was distributed in 

2019 for influenza and MMR

 AAP Pediatrician Life and Career Experience Study (PLACES) survey1

– 75% of pediatricians in primary care reported that their main work 

setting is enrolled as a COVID-19 provider with their state

– 70% have started giving the vaccine to 12- to 18-year-old patients

1. https://www.aappublications.org/news/2021/10/01/researchupdate100121

AAP= American Academy of Pediatrics
Acceptability

Summary

 Most jurisdictions plan to utilize a variety of implementation strategies to 

vaccinate children 5–11 years

 Parents report greatest comfort with receiving COVID-19 vaccine at their 

primary care providers' offices

– Jurisdictions anticipate most children will be vaccinated at pediatric providers

 >70% of VFC providers are already enrolled as COVID-19 vaccine providers
Acceptability

Is Pfizer-BioNTech 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?

o No o Probably no o Probably yes o Yes o Varies o Don’t know
EtR Domain: Feasibility
Pediatric COVID-19 vaccination implementation goals

 Enable access to and availability of vaccine providers where populations are 

mostly likely to seek vaccination (reach the most)

 Ensure programming to ensure access to vaccine for vulnerable and 

underserved pediatric populations (hard to reach)

 ~28.7 million children 5–11 years of age1

1U.S. Census Bureau, Population Division, 2020 Demographic Analysis 
 New formulation can be 

stored at refrigerator 

temperature (2–8oC) for up to 

10 weeks prior to use

 100 dose minimum order size

Feasibility

Pediatric formulation 

Source: Jurisdiction data call survey – 09/27/21. n=58.

 Different vaccine formulation may lead to administration errors

– Provider education ongoing
Feasibility

Is the Pfizer-BioNTech COVID-19 vaccine feasible to

implement among children aged 5–11 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?

o No o Probably no o Probably yes o Yes o Varies o Don’t know
EtR Domain: Resource Use
Resource use

 U.S. Government has purchased enough vaccine to support vaccination of the 

pediatric population of children 5-11 years1

 Vaccine will be available at no cost

 No studies evaluated cost-effectiveness with COVID-19 vaccines and children

 Work Group concluded that cost-effectiveness may not be a primary driver for 

decision-making during a pandemic and for vaccine used under EUA 

– Will need to be reassessed for future recommendations

 Use of COVID-19 vaccines in as many populations as possible will be important 

to returning to pre-pandemic activities

– Return to pre-pandemic activities likely have positive economic impact

1 https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf
Resource Use

Is the Pfizer-BioNTech COVID-19 vaccine among children aged 

5–11 years a reasonable and efficient allocation of resources?

• What is the cost-effectiveness of the Pfizer-BioNTech COVID-19 vaccine?

• How does the cost-effectiveness of the Pfizer-BioNTech COVID-19 vaccine 

change in response to changes in context, assumptions, etc?

o No o Probably no o Probably yes o Yes o Varies o Don’t know
EtR Domain: Equity
Children that could be disproportionately affected by COVID-19 

or in access to healthcare

61

 Place of residence

– Living in rural/frontier areas

– Justice-involved (incarcerated 

persons/families)

– Living in congregate settings (long-term 

care facilities, boarding schools)

– Experiencing homelessness

 Racial and ethnic minority populations

– Black, Hispanic or Latino, and Alaskan 

Native/American Indian

– Immigration status

 Gender/sexual identity

– LGBTQ+ 

 Socioeconomic status

– Families with lower incomes

– High social vulnerability

 Personal characteristics associated with 

discrimination

– Children with disabilities

 Features of relationships

– Family instability

– Not enrolled in school
62

Disparities in adolescent COVID-19 vaccine coverage

National Immunization Survey – Aug 29 – Sept 25, n=1,445 

Adolescents 13–17 years

Endorser 

vaccinated

Endorser

definitely plan to get 

vaccinated

Reluctant

probably/definitely will not get 

vaccinated

Reachable

probably will get 

vaccinated/unsure
63

Endorser 

vaccinated

Endorser

definitely plan to get 

vaccinated

Reluctant

probably/definitely will not get 

vaccinated

Reachable

probably will get 

vaccinated/unsure

Disparities in adolescent coverage

National Immunization Survey – Aug 29 – Sept 25, n=1,445 

Adolescents 13–17 years
64

Summary of NIS findings

▪ Nearly 5 months after adolescent vaccine roll out there remains

unrealized intent for adolescent COVID-19 vaccinations 

– Largest for adolescents living in poverty and rural areas 

▪ It is critical for CDC and public health partners to redouble efforts for 

equitable access to COVID-19 vaccinations

– Can include strategies such as school located vaccinations
Trusted providers in the medical home (primary 

care providers, FQHCs, rural health clinics, 

community health centers, children’s hospitals)

↑ % VFC providers enrolled

↓ minimum order size

↑ redistribution

Partnerships between schools and pharmacies 

and local health departments to run school 

located vaccination clinics to improve access for 

those without a medical home

↑ technical assistance and 

targeted partnerships

Utilizing the broad reach of pharmacies

>60% of adolescents vaccinated 

received a COVID-19 vaccine 

through a pharmacy

Opportunities to increase equitable access to COVID-19 vaccines 
Equity

What would be the impact of the Pfizer-BioNTech COVID-19 

vaccine among children aged 5–11 years on health equity?

• Are there groups or settings that might be disadvantaged in relation to 

COVID-19 disease burden or receipt of the Pfizer-BioNTech COVID-19 

vaccine?

• Are there considerations that should be made when implementing the 

Pfizer-BioNTech COVID-19 vaccine program to ensure that inequities are 

reduced whenever possible, and that they are not increased?

o Reduced o Probably reduced o Probably no impact

o Probably increased o Increased o Varies o Don’t know
Summary
68

EtR DomainQuestion

Work Group Judgments

Public Health 

Problem

Is COVID-19 disease among children aged 5–11 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? Favors the intervention

What is the overall certainty of the evidence for the critical outcomes? Critical benefits: type 1

Critical harms: type 4

Values

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

the undesirable effects?

Large

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

Acceptability

Is the Pfizer-BioNTech COVID-19 vaccine acceptable to key stakeholders?Yes

Feasibility

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

children aged 5–11 years?

Yes

Resource Use

Is the Pfizer-BioNTech COVID-19 vaccine, given to children aged 5–11 

years a reasonable and efficient allocation of resources?

Yes

Equity

What would be the impact of the Pfizer-BioNTech COVID-19 vaccine, 

given to children aged 5–11 years on health equity?

—
Work Group interpretation 

 Vaccine policy decisions made on balance of known benefits and risks to individual

– Other benefits (prevention of transmission; greater confidence in return to school/social 

interactions) and risks (extrapolation of myocarditis risk from other ages) part of a 

broader picture

 Experience with over >400 million doses of mRNA vaccines administered to people 

12 years of age and older 

 Benefits outweigh risks

– Regardless of seropositivity rates, the benefit/risk balance still favorable 

69
70

Child 5-11 

years of 

age

Prevention of 

COVID-19 cases

>90%

Possible impact with vaccination of 5–11-year-old

Likely prevention of COVID-19 related:

Post-COVID conditions

MIS-C

Hospitalization

ICU

Death

Possibility for more social interactions 

and uninterrupted school
71

Child 5-11 

years of 

age

Family

Possible prevention of 

transmission to 

vulnerable family 

members

Possible impact with vaccination of 5–11-year-old

Parental participation on 

work force may be more 

stable and predicable
72

Child 5-11 

years of 

age

Family

Could result in 

lower 

transmission 

within schools 

and community 

Community

Possible impact with vaccination of 5–11-year-old

More confident 

return to 

in-person 

learning
Next steps

 As with all ages and vaccines, close monitoring of post-authorization safety 

surveillance is critical and ongoing

 Vaccine recommendations made under EUA are interim and will be reviewed at 

the time of BLA submission

– At that time, longer follow-up time for children enrolled in clinical trials 

– Can update benefit/risk analysis with additional data from clinical trial, as well as 

post-authorization safety surveillance

 Continue to evaluate ways to mitigate risks of rare events after vaccination

73
Platform

name Platform details

Outcomes studied

Immunogenicity

Household

transmission Infection Outpatient

Emergency

department/

urgent care Hospitalization MIS-C

Cohort

PROTECT Weekly swabbing of 2,000 kids  

CASCADIA Weekly swabbing of 715 kids 

PACC Weekly swabbing of 400 kids  

RVTN Case-ascertained transmission 

study of 1,500 households

 

Test-negative

ICATT National pharmacy testing data 

VISION* Electronic health records at 

458 pediatric hospitals, ED/UCs

  

Overcoming

COVID

30-40 pediatric hospitals  

Plans for post-authorization monitoring of COVID-19 

vaccine effectiveness among children 5-11 years of age

74

PROTECT = Pediatric Research Observing Trends and Exposures in COVID-19 Timelines; ; PACC = Prospective Assessment of COVID-19 in the Community; RVTN = Respiratory Virus Transmission Network; UCSF 

= University of California, San Francisco; ICATT = Increasing Community Access To Testing partnership * A cohort design is currently being assembled in a subset of 

VISION sites.

First VE estimates may occur as early as 60-90 days after authorization; 

timelines will depend on vaccine coverage and background rates of disease
Summary

Since beginning of the COVID-19 pandemic, among U.S. children 5-11 

years of age, there have been 

1.9 million cases

8,300 hospitalizations

2,316 MIS-C cases 

94 deaths 

75
Summary

Since beginning of the COVID-19 pandemic, among U.S. children 5-11 

years of age, there have been 

1.9 million cases

8,300 hospitalizations

2,316 MIS-C cases 

94 deaths 

76

COVID-19 is now 

vaccine preventable 
77

Evidence to Recommendations Framework

Summary: Work Group Interpretations

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
78

Evidence to Recommendations Framework

Summary: Work Group Interpretations

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 
Acknowledgements

 Kate Woodworth

 Danielle Moulia

 Jefferson Jones

 Jennifer Collins

 Steve Hadler

 Jack Gersten

 Eddie Shanley

 Monica Godfrey

 Kathleen Dooling

 Sarah Mbaeyi

 Epi Task Force

– COVID-NET

– DVD Enhanced Surveillance

– Community Surveillance

– Seroprevalance

 MIS-C unit

 Data, Analytics and Visualization Task Force

 Immunization Services Division

 FluSurv-NET

 Unplanned School Closure Monitoring Project, 

Division of Global Migration and Quarantine

 Division of Vital Statistics, National Center for 

Health Statistics
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.