cdc.gov/coronavirus

EtR Framework:

Pfizer-BioNTech COVID-19 vaccine in 

adolescents aged 12-15 years

Sara Oliver, MD, MSPH

ACIP Meeting

May 12, 2021
Evidence to Recommendations Framework
Evidence to Recommendations (EtR) 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

Policy Question

 Should vaccination with Pfizer-BioNTech COVID-19 vaccine 

(2-doses, IM) be recommended for persons 12-15 years of age 

under an Emergency Use Authorization?
Population Persons aged 12-15 years

Intervention Pfizer-BioNTech COVID-19 vaccine (BNT162b2)

Comparison No Vaccine

Outcomes

Symptomatic laboratory-confirmed COVID-19

Hospitalization due to COVID-19

Multisystem inflammatory syndrome in children (MIS-C)

SARS-CoV-2 seroconversion to a non-spike protein

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

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 Question

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 adolescents aged 12–15 years

“The problem” = COVID-19 among adolescents aged 12–15 years
EtR Domain: Public Health Problem
o o o o o o

Public Health Problem

Is COVID-19 disease among adolescents aged 12–15 

years of public health importance?

• Are the consequences of COVID-19 serious?

• Is COVID-19 urgent? 

• Are a large number of adolescents affected by COVID-19?

• Are there populations disproportionally affected by COVID-19?

No Probably no Probably yes Yes Varies Don’t know
Public Health Problem:

Review of the available evidence

 COVID-19 incidence and burden estimates

 COVID-19 associated hospitalization rates

 COVID-19 associated mortality

 Multisystem Inflammatory Syndrome in Children (MIS-C)

 Transmission
Trends in Number of COVID-19 Cases in the US

0

50000

100000

150000

200000

250000

300000

350000

Jan 22 2020 Apr 24 2020 Jul 26 2020 Oct 27 2020 Jan 28 2021 May 1 2021

January 22, 2020 – May 3, 2021

May 3 2021

https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
Trends in Number of COVID-19 Cases among 

Adolescents 12-17 Years of Age

March 1, 2020 – April 30, 2021

>1.5 million 

cases among 

adolescents 12-17 

years of age

0

50

100

150

200

250

300

350

400

450

Incident Cases per 100,000 Population

Case Earliest Date by Week

12 - 15 Years

16 - 17 Years

https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% of Total Cases

0-11 years 12-17 years 18-49 years 50-64 years ≥65 years

Proportion of Total COVID-19 Cases by Age Group

— United States, March 1, 2020–April 30, 2021

As more adults 

vaccinated, adolescents 

aged 12-17 years of age 

make up a greater 

proportion of total cases: 

9% of cases reported in 

April 2021

9%

56%

18%

8%

9%

https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
Percent of Total Estimated COVID-19 Cumulative 

Incidence and Total Population by Age Group 

— United States, February 2020–March 2021

0% 20% 40% 60% 80% 100%

0-4 Years

5-17 Years

18-49 Years

50-64 Years

65+ Years

% of Total Estimated COVID-19 Cumulative Incidence % of Total Population*

Once adjusting for 

underreporting, 

22.2 million

SARS-CoV-2 infection in 

children and adolescents 

5-17 years of age

* Sources: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html 

U.S. Census Bureau, Population Division, 2020 Demographic Analysis (December 2020 release) 
Estimated Rates of COVID-19 Disease Outcomes 

per 100,000 population, by Age Group

— United States, February 2020–March 2021

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html

0

10,000

20,000

30,000

40,000

50,000

0-4 Years 5-17 Years 18-49 Years 50-64 Years ≥65 Years

Rate Per 100,000

Infections Symptomatic Illness Hospitalization

High rates of infections and symptomatic illness in children 5-17 years of age

Proportion of symptomatic patients hospitalized lower among children
Cumulative Rates of COVID-19-Associated Hospitalizations by 

Select Age Groups — COVID-NET, Mar 1, 2020–Mar 27, 2021

0

50

100

150

200

Rate Per 100,000 Population

0-4 yr 5-11 yr 12-17 yr 18-29 yr

https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html
Cumulative Rates of COVID-19-Associated Hospitalizations by 

Select Age Groups — COVID-NET, Mar 1, 2020–Mar 27, 2021

0

50

100

150

200

Rate Per 100,000 Population

0-4 yr 5-11 yr 12-17 yr 18-29 yr

https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html
Three-week Moving Average Rate of Hospitalization by 

Select Age Groups —COVID-NET, Dec 27, 2020–April 17, 2021
Cumulative 2009 H1N1 Influenza- and COVID-19-Associated 

Hospitalization among Adolescents 12-17 years by MMWR week

—FluSurv-NET and COVID-NET

0

10

20

30

40

50

60

10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 2 4 6 8 10 12 14 16 18

Rates Per 100,000 

Population

MMWR Week 

2009-2010 COVID-19

*The 2009-2010, H1N1 pandemic season, includes data from MMWR week 15-39 of the 2008-2009 season

Influenza
Cumulative Influenza- and COVID-19-Associated Hospitalizations 

Rates among Adolescents 12-17 years by MMWR week

—FluSurv-NET and COVID-NET

*The 2009-2010, H1N1 pandemic season, includes data from MMWR week 15-39 of the 2008-2009 season

0

10

20

30

40

50

60

10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 2 4 6 8 10 12 14 16 18

Rates Per 100,000 

Population

MMWR Week 

2009-2010 2017-2018 2018-2019 2019-2020 COVID-19

Influenza

Note: Influenza season begins at MMWR week 40, 

cumulative rates over a shorter period of time
Hospitalized Children 12–17 Years (n=772)

—COVID-NET, Mar 2020–Jan 2021

N (%)

Age (years) ‒ median (IQR) 15 (14-17)

Sex – Male 369 (48)

Race/ethnicity

Hispanic 249 (32)

non-Hispanic Black 238 (31)

non-Hispanic White 202 (26)

non-Hispanic Other 83 (11)

Severe disease§ 239 (31)

≥1 underlying condition 471 (61)

§Requiring intensive care unit admission or mechanical ventilation

*BMI (kg/m2) ≥95th percentile for age and sex based on CDC growth charts, ICD-10 codes for obesity, or obesity selected on case report form

†Includes gastrointestinal or liver disease; renal disease; rheumatologic, autoimmune, inflammatory conditions; abnormality of the airway.

COVID-19-associated hospitalizations reported to COVID-NET surveillance system March 1, 2020–January 31, 2020. COVID-NET is a population-based surveillance system that collects data on 

laboratory-confirmed COVID-19-associated hospitalizations among children and adults through a network of over 250 acute-care hospitals in 14 states.

0 5 10 15 20 25 30 35

Other condition†

Chronic metabolic disease

Feeding tube dependence

Chronic lung disease

Cardiovascular disease

Neurologic disorders

Blood disorders

Immunosuppressed conditions

Diabetes mellitus (type 1 or 2)

Developmental delay

Asthma

Obesity*

Percentage of Hospitalized Persons Aged 12–17 Years
Hospitalized Children 12–17 Years (n=772)

—COVID-NET, Mar 2020–Jan 2021

N (%)

Age (years) ‒ median (IQR) 15 (14-17)

Sex – Male 369 (48)

Race/ethnicity

Hispanic 249 (32)

non-Hispanic Black 238 (31)

non-Hispanic White 202 (26)

non-Hispanic Other 83 (11)

Severe disease§ 239 (31)

≥1 underlying condition 471 (61)

§Requiring intensive care unit admission or mechanical ventilation

*BMI (kg/m2) ≥95th percentile for age and sex based on CDC growth charts, ICD-10 codes for obesity, or obesity selected on case report form

†Includes gastrointestinal or liver disease; renal disease; rheumatologic, autoimmune, inflammatory conditions; abnormality of the airway.

COVID-19-associated hospitalizations reported to COVID-NET surveillance system March 1, 2020–January 31, 2020. COVID-NET is a population-based surveillance system that collects data on 

laboratory-confirmed COVID-19-associated hospitalizations among children and adults through a network of over 250 acute-care hospitals in 14 states.

0 5 10 15 20 25 30 35

Other condition†

Chronic metabolic disease

Feeding tube dependence

Chronic lung disease

Cardiovascular disease

Neurologic disorders

Blood disorders

Immunosuppressed conditions

Diabetes mellitus (type 1 or 2)

Developmental delay

Asthma

Obesity*

Percentage of Hospitalized Persons Aged 12–17 Years

61% of 

hospitalized 

adolescents 

with COVID-19 

had an 

underlying 

medical 

condition 
0

500

1000

1500

2000

2500

3000

3500

4000

4500

Jan 22 2020 Apr 24 2020 Jul 26 2020 Oct 27 2020 Jan 28 2021 May 1 2021

Trends in Number of COVID-19 Deaths in the US

January 22, 2020 – May 3, 2021

May 3 2021

https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases
0

10

20

30

40

50

60

70

80

90

100

<1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

COVID-19 Deaths

Age in Years

COVID-19 Deaths by Age Group, NCHS

—January 1, 2020–April 30, 2021

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

Adolescents 12–17 years: 

127 COVID-19 deaths

1.3% of all deaths among

adolescents
Multisystem Inflammatory Syndrome in Children 

(MIS-C)

 Severe hyperinflammatory syndrome occurring 2-6 weeks after acute SARS-CoV-2 

infection, resulting in a wide range of manifestations and complications

– 60-70% of patients are admitted to intensive care, 1-2% die1,2

 3,742 MIS-C cases have been reported to national surveillance as of May 3, 20213

– Median age of 9, with 21% (804) of cases occurred in adolescents 12-17 years

– 63% of reported cases have occurred in children who are Hispanic/Latino or 

Black, Non-Hispanic

– Estimated incidence of 1 to 8.5 MIS-C cases per million person-months

1. Feldstein LR, Tenforde MW, Friedman KG, et al. Characteristics and Outcomes of US Children and Adolescents With Multisystem Inflammatory Syndrome in Children (MISC) Compared With Severe Acute COVID-19. JAMA. 2021;325(11):1074-1087. doi:10.1001/jama.2021.2091

2. Belay ED, Abrams J, Oster ME, et al. Trends in Geographic and Temporal Distribution of US Children With Multisystem Inflammatory Syndrome During the COVID-19 

Pandemic [published online ahead of print, 2021 Apr 6]. JAMA Pediatr. 2021;e210630. doi:10.1001/jamapediatrics.2021.0630

3. Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States. https://www.cdc.gov/mis-c/cases/index.html
Severity of Multisystem Inflammatory Syndrome in 

Children (MIS-C) by Age

1.9

2.6

1.7

2.4

0 1 2 3 4

6-12 yr

13-20 yr

6-12 yr

13-20 yr

ICU Admission

Decreased Cardiac

Function

Odds Ratio

MIS-C Severity

Abrams JY, Oster ME, Godfred-Cato SE, et al. Factors linked to severe outcomes in multisystem inflammatory syndrome in children (MIS-C) in the USA: a retrospective surveillance study. Lancet 

Child Adolesc Health. 2021;5(5):323-331. doi:10.1016/S2352-4642(21)00050-X

Reference: 

MIS-C patients aged 

0–5 years of age

13-20 yr

13-20 yr

6-12 yr

6-12 yr
Adolescents and Transmission of SARS-CoV-2

 Some studies observed similar infection rates between children and adults, while 

others found lower infection rates among children compared with adults1,2

 Adolescents may be more likely to be infected than younger children (<10 years)

– Supported by contact tracing, test positivity, and population-based seroprevalance data2

 Secondary transmission from adolescents can and does occur

– While SARS-CoV-2 transmission among students relatively rare, several studies suggest 

transmission more likely within high school than elementary school settings3,4

1. Bi Q et al. Lancet Infect Dis. 2020;20(8):911-919

2. CDC Science Brief: Transmission of SARS-CoV-2 in K-12 schools. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/transmission_k_12_schools.html

3. Goldstein E et al. On the Effect of Age on the Transmission of SARS-CoV-2 in Households, Schools, and the Community. J Infect Dis. 2021 Feb 13;223(3):362-369.

4. Larosa E et al. Secondary transmission of COVID-19 in preschool and school settings in northern Italy after their reopening in September 2020. Euro Surveill. 2020;25(49):2001911.
Adolescents and Transmission of SARS-CoV-2

1. Lopez A et al. MMWR Morb Mortal Wkly Rep 2020;69:1319–1323

2. Schwartz N et al. MMWR Morb Mortal Wkly Rep 2020;69:1457–1459

 Outbreak investigations have demonstrated efficient transmission among children, 

adolescents, and young adults, including transmission to older household members
Adolescents and Transmission of SARS-CoV-2

Lessler J et al. Household COVID-19 risk and in-person schooling [published online ahead of print, 2021 Apr 29]. Science. 2021;eabh2939. doi:10.1126/science.abh2939

COVID-19-related outcomes 

compared to households 

with children not attending 

in-person school (reference), 

prior to adjustment for 

mitigation efforts

Adults living in a household with a child engaged in full-time in-person school had an 

increase in odds of reporting COVID-19 like illness, loss of taste/smell, or positive 

SARS-CoV-2 test within previous 14 days
Public Health Problem:

Summary of the available evidence

Adolescents 12–17 years of age are at risk of severe illness from COVID-19

 Over 1.5 million reported cases and >13,000 hospitalizations to date

– Hospitalization rate higher than 2009-10 H1N1 pandemic

 Clinical presentation of MIS-C more severe in adolescents than in younger 

children

COVID-19 in adolescents may also indirectly impact others' health

 Adolescents contribute to transmission in households and communities

– Including older vulnerable populations

 Adolescents represent an increasing proportion of recent COVID-19 cases
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among adolescents aged 12–15 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

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 a 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
Benefits and Harms:

Summary of the Available Evidence: Benefits

 The clinical trial for the Pfizer-BioNTech COVID-19 vaccine demonstrated 

efficacy against symptomatic, laboratory-confirmed COVID-19. The efficacy 

was 100%

High certainty of evidence
Benefits and Harms:

Summary of the Available Evidence: Benefits

 The geometric mean ratio (GMR) for antibodies in 12–15-year-olds 

compared with 16–25-year-olds was 1.76 (95% CI:1.47, 2.10), and met the 

noninferiority criteria

 No hospitalizations due to COVID-19 or cases of MIC-C were reported by 

any trial participants
Benefits and Harms:

Summary of the Available Evidence: Harms

 Serious adverse events (SAE) were reported in a higher proportion of 

recipients of vaccine versus placebo (0.4% vs 0.2%) based on 5 SAEs in the 

vaccine group and 2 in the placebo group

Very low certainty of evidence

 Severe reactions were more common in vaccine recipients; a grade ≥3 

reaction was reported by 10.7% of vaccinated versus 1.9% of placebo group

High certainty of evidence
Benefits and Harms:

Summary of the Available Evidence: Harms

 No deaths were reported among any trial participants

 Local reactions within 7 days occurred in 91% vaccine recipients

– Pain at the injection site most common

 Systemic reactions within 7 days occurred in 91% vaccine recipients

– Fatigue and headache most common

 Most symptoms resolved in 1-2 days
Benefits and Harms:

Summary of the Available Evidence: Harms

 No cases of anaphylaxis reported in the adolescent (12-15 years of age) 

study participants

 No cases of Bell’s Palsy or facial paralysis reported in adolescents

 Among adolescents 12-15 years of age, 7 (0.6%) in the vaccine group had 

lymphadenopathy, compared to 1 (0.1%) participant in the placebo group 

– Most lymphadenopathy was local (arm or neck region), occurred on the same 

side as vaccination, and was reported within 2-10 days
Summary of GRADE

Evidence type: 1=high; 2=moderate; 3=low; 4=very low; ND, no data. 41

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Symptomatic lab-confirmed 

COVID-19

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

symptomatic COVID-19

1

Hospitalization due to COVID-19Important No studies Data not available from any studies ND

Multisystem inflammatory 

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

SARS-CoV-2 seroconversion Important No studies Data not available from any studies ND

Asymptomatic SARS-CoV-2 

infection Important No studies Data not available from any studies ND

Harms

Serious adverse eventsCritical RCT (1)

5 SAEs among vaccinated and 2 among unvaccinated; certainty in 

the estimate was very low. No SAEs were judged to be related to 

vaccination.

4

Reactogenicity Important RCT (1)

Severe reactions were more common in vaccinated; any grade ≥3 

reaction was reported by 10.7% of vaccinated vs. 1.9% of placebo 

group

1
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
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?
Values:

Review of the Available Evidence

 Review of scientific literature, news media, and reports

– Pubmed: (COVID-19 OR coronavirus OR SARS-CoV-2) AND (vaccin* OR 

immunization) AND (survey OR questionnaire OR poll) AND (adolescent OR 

child* OR parent*)

– Google: “COVID-19,” “coronavirus,” “vaccine,” “survey,” “poll,” “hesitancy,” 

“intent,” “willingness”

– Societal Experts Action Network COVID-19 Survey Archive

 Limited to surveys conducted since authorization of COVID-19 vaccines 

(December 2020)
Positive COVID-19 Vaccination Intention among Adults†

†Surveys with multiple time points are shown with the same color bubble for each time point. Surveys with only one time point are shown in gray.

*Positive vaccine intentions includes persons reporting definitely, probably, or somewhat likely to get vaccinated themselves. Some surveys also included persons who already received vaccine.
Values:

Surveys of Parents (intent to have children vaccinated)

 Among parents surveyed, 46-60% plan to get their children vaccinated1-4

 Reasons for not vaccinating2:

– not sure it will be safe (59%)

– Vaccine developed too quickly (59%)

– don’t trust info being published about the vaccine (48%)

– won’t trust right away (44%)

– don’t have enough info (43%)

 Parents reported similar or slightly lower intent to vaccinate their children 

compared to intent to vaccinate themselves3,4

1. Axios/Ipsos April 2-5; Axios/Ipsos April 16-19; Calarco and Anderson preprint; WebMD March 2021.

2. National Parents Union Survey January 2021

3. Simonson M, Baum M, Lazer D, et al. The COVID States Project #45: Vaccine hesitancy and resistance among parents.OSF Preprints, 19 Mar. 2021. https://doi.org/10.31219/osf.io/e95bc

4. Parents Together March 2021 Survey
Values:

Surveys of Parents (intent to have children vaccinated)

 Intent to vaccinate children differed by parent's gender, age & income status

 Fathers were more willing to vaccinate their children than mothers

 Older mothers were more willing to vaccinate their children than younger mothers

 Higher income households were more likely to report intent to vaccinate

 Lower income households twice as likely to say “not sure” about vaccinating their 

children compared to higher income households

Simonson preprint; Calarco and Anderson preprint; National Parents Union Survey January 2021; Parents Together March 2021 Survey
Values: Parents' Intent for Children to Receive COVID-19 

Vaccine Varies by Race/Ethnicity

*Positive vaccine intentions includes persons reporting definitely or probably likely to get their child vaccinated.
Values: Surveys of Adolescents and Parents 

Intent to get vaccine/have children vaccinated

Adolescents 13-17 years

(n=839)

Parents of Adolescents 12-17 years

(n=766)

51%

definitely/probably

will get vaccinated

55%

definitely/

probably

will get adolescent

vaccinated

CDC/U Iowa Survey of Parents and Adolescents, April 2021
Values: Surveys of Adolescents and Parents 

Intent to get vaccine/have children vaccinated

 Intent to vaccinate adolescents among the combined sample varied:

– Higher for male than female adolescents (57% vs. 50%)

– Higher for adolescents whose parents had at least a four-year degree 

(66%) vs. parents with less education (48%-50%)

– Higher in Northeast (64%) and West (60%) vs. Midwest (47%) and 

South (49%) 

 No differences in intent for adolescent COVID-19 vaccination by respondent 

race/ethnicity

CDC/U Iowa Survey of Parents and Adolescents, April 2021
Values: Surveys of Adolescents and Parents 

Concern for COVID-19 or vaccines

Level: 1 = not concerned; 2 = slightly concerned; 3 = somewhat concerned; 4 = very concerned

CDC/U Iowa Survey of Parents and Adolescents, April 2021
Values:

Summary of the Available Evidence

 About half of parents say they are likely to get their adolescent vaccinated

 Intent to vaccinate adolescents differed by parents' gender, race, and income

 Intent to vaccinate adolescents similar or slightly lower than parental intent 

to get vaccinated

 Limited information available on adolescent intent to be vaccinated
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

Is the 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
Strategy Description Example %Share of jurisdictions

Multi-pronged 

approach

• Using a combination of the three 

below approaches, often staged 

over time.

Region 8 jurisdiction: "Believe a hybrid 

model will be needed by utilizing enrolled 

providers and other pending outreach 

activities."

Existing 

provider 

network

• Reaching adolescents through 

existing enrolled provider 

network, including mass vax and 

public health sites.

Region 1 jurisdiction: "Plan to encourage in 

all existing channels including mass 

vaccination clinics, retail pharmacy partners, 

and some local health dept clinics."

Pediatric 

providers and 

PCPs

• Emphasis on reaching population 

through activation of new 

pediatric providers and family 

doctors.

Region 4 jurisdiction: "Actively recruiting for 

additional pediatricians to join the COVID 

enrollment. Sent out notification to bring on 

additional providers."

46%

28%

15%

School-based 

clinics

• Preparing school-based clinics 

and events to reach population 

through temporary PODs.

Region 4 jurisdiction: "Received interest 

from schools with successful teacher 

vaccination clinics ...will use grant funds to 

support these."

11%

Source: Jurisdiction data call survey – 05/03/21-05/06/21. n=46.

Acceptability:

Jurisdictional approach to administer COVID-19 vaccine

 April 10th pulse of jurisdictional immunization programs on implementation 

planning for adolescents 
Acceptability:

Provider willingness to administer COVID-19 vaccine

 October-December 2020 Survey: family physicians, pediatricians, and internal 

medicine physicians very willing to administer COVID-19 vaccine in their practices

– 97% of providers were willing to administer COVID-19 vaccine

– Largest perceived barrier to vaccination was parent/patient concern about 

safety of COVID-19 vaccine

Kempe A, et al. Primary Care Physicians’ Willingness and Capacity to Contribute to COVID-19 Vaccine Delivery. Unpublished.
Acceptability: Comfort with adolescent receiving 

COVID-19 vaccine at each site

CDC/U Iowa Survey of Parents and Adolescents, April 2021
Acceptability:

Summary of the available evidence

 Most jurisdictions utilizing a variety of implementation strategies to 

vaccinate adolescents 

 Nearly all primary care providers surveyed are willing to provide 

COVID-19 vaccines to their patients

 Adolescents and their parents report greatest comfort with receiving 

COVID-19 vaccine at their primary care providers' offices
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
Feasibility

Is the Pfizer/BioNTech COVID-19 vaccine feasible to

implement among adolescents aged 12–15 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
Implementation objectives

 Promote adolescent vaccination as quickly and equitably as possible 

through a multi-pronged approach

 Jurisdictions and providers currently vaccinating adolescents 16-17 years

 Leverage current COVID-19 vaccination infrastructure to adapt over time:

– Early summer sprint (May-June)

– Increase access (June-July)

– Back-to-school campaign (July-September)
Stepwise approach to increasing vaccine access for 

adolescents

Augment existing infrastructure for vaccination 

Strategically add providers that can reach adolescents

Apply school-focused strategies to 

ensure vaccination opportunities

Adolescent 

vaccination

3

1

2

May June July August September
Category Approach

Primary care providers serving 

adolescents

Utilize primary care as trusted providers to notify, 

schedule, and vaccinate their patients, including managing 

routine immunizations, particularly as students return to 

school

Pharmacies and HRSA sites1

Leverage broad pharmacy footprint and HRSA sites to 

administer COVID-19 vaccine to adolescents rapidly, as 

with adults

School-based vaccination

Partner with Federally Qualified Health Centers, 

pharmacies, public health, and adolescent provider 

networks to hold targeted programs at schools to ensure 

equity and coverage, particularly as students return

1. Health Resources and Services Administration (HRSA) sites including: Federally Qualified Health Centers (FQHCs), Rural Health Clinics, Community Health Centers

Augment existing public health infrastructure and add 

new channels to vaccinate adolescents
Feasibility:

Additional considerations

 Current cold-chain storage requirements and package sizes could limit the 

availability of the Pfizer-BioNTech COVID-19 vaccine.

 Allocation/prioritization of Pfizer-BioNTech for adolescents 12-17 years

 Consent/assent

– No federal, legal requirement for caregiver consent for COVID-19 vaccination 

or any other vaccination. However, COVID-19 vaccine must be administered 

according to applicable state and territorial vaccination laws, including those 

related to consent.
Feasibility

Is the Pfizer/BioNTech COVID-19 vaccine feasible to

implement among adolescents aged 12–15 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

Is the Pfizer/BioNTech COVID-19 vaccine, given to adolescents aged 

12–15 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
Resource Use:

Review of the available evidence

 U.S. Government has purchased 600 million doses of mRNA vaccines1

– 300 million doses of Pfizer COVID-19 vaccine, delivered in regular increments through 

the end of July 2021

 Vaccine will be available at no cost

 No studies evaluated cost-effectiveness around the use of COVID-19 vaccines 

among adolescents

 Vaccinating adolescents may allow greater confidence in safe return to school

– Reduced work/school absenteeism related to COVID-19 quarantine and isolation

– Estimated that over time, school closures could have total economic loss as high as 

$15 trillion in the US2

1 https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-additional-doses-covid-19-vaccines-from-pfizer-and-moderna.html 2 https://www.oecd.org/education/the-impact-of-covid-19-on-education-insights-education-at-a-glance-2020.pdf ; 

https://www.cnbc.com/2020/09/08/school-disruption-could-cost-the-us-economy-15point3-trillion-oecd.html
Resource Use:

Work Group Interpretation

 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
Resource Use

Is the Pfizer/BioNTech COVID-19 vaccine among adolescents aged 

12–15 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
Equity

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

vaccine, given to adolescents aged 12–15 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 PfizerBioNTech 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
Equity:

Review of the available evidence

 Identification of groups that might be disadvantaged in relation to COVID-19 

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

– PROGRESS-Plus Framework:1 Place of residence, race or ethnicity, gender or sex, socioeconomic 

status, disability, other

 Review of the scientific and gray literature

 Review of CDC COVID-19 response data and resources

– CDC COVID Data Tracker & COVID-19-Associated Hospitalization Surveillance Network (COVID-NET)

– National Center for Health Statistics

– CDC Science Brief: Evidence used to update the list of underlying medical conditions that increase a 

person’s risk of severe illness from COVID-19

1 PROGRESS-Plus is an acronym to identify factors associated with unfair differences in disease burden and the potential for interventions to reduce these differential effects. 

See O'Neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in 

health. J Clin Epi. 2014;67: 56-64; Welch VA, Akl EA, Guyatt G, et al. GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and 

rationale. J Clin Epidemiol. 2017;90:59-67.
COVID-19: Which Adolescent Groups Could Be Disadvantaged?

81

 Place of residence

– Living in rural/frontier areas

– Justice-involved (incarcerated persons)

– Living in congregate settings (long-term 

care facilities)

– Experiencing homelessness

 Racial and ethnic minority populations

– Black, Hispanic or Latino, and Alaskan 

Native/American Indian

– Immigration status

 Occupation

– Frontline workers or children of 

frontline workers

 Gender/sex

– LGBTQ+

 Socioeconomic status

– Poverty

– High social vulnerability

 Personal characteristics associated with 

discrimination

– With disabilities

 Features of relationships

– Emancipated minors

– Not enrolled in school

 Substance use
82

Disproportionate COVID-19 morbidity and mortality Barriers to healthcare

Adolescents Adults

Rural or frontier areas  

Justice-involved  

Congregate settings 

Homelessness  

Race/ethnicity   

Immigration status 

Occupation 

Sexual and gender minorities 

Socioeconomic status  

Disabilities   

Substance use   

Equity: Review of the available evidence

 = Published peer-reviewed literature available
Equity:

Data on equitable provision of COVID-19 vaccine in adults

As of May 4,2021, a lower 

percentage of Black and 

Hispanic/Latino adults were fully 

vaccinated compared with the 

percentage of these groups 

in overall population

May see similar patterns in 

adolescents

CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic as of May 4, 2021, and US Census Bureau National Population Estimates

0 20 40 60 80

White Non-Hispanic

Hispanic/Latino

Black Non-Hispanic

Asian Non-Hispanic

AIAN Non-Hispanic

NHOPI Non-Hispanic

Multiple/Other Non-Hispanic

% US Population % Persons Fully Vaccinated
Equity:

Opportunities to increase equitable access to the 

Pfizer-BioNTech COVID-19 vaccine 

 Pfizer-BioNTech COVID-19 vaccine characteristics

– Submitted new data to FDA supporting stability of vaccine when stored for up to one 

month (31 days) at 2-8°C1

– Encourage strategies to efficiently utilize doses and support local redistribution, smaller 

tray sizes would improve access (e.g., smaller providers, rural areas)

 Need for 2-dose series 

– In adults, only 3% missed the second dose of a 2-dose series, but differences were seen 

by jurisdiction, race/ethnicity, and age2

 Multipronged approach to improve access

– Primary care providers serving adolescents, FQHCs, rural health clinics, community 

health centers, children’s hospitals, pharmacies, school-located vaccination clinics

1. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer

2. Kriss JL, Reynolds LE, Wang A, et al. COVID-19 Vaccine Second-Dose Completion and Interval Between First and Second Doses Among Vaccinated Persons — United States, 

December 14, 2020−February 14, 2021. MMWR Morb Mortal Wkly Rep 2021;70:389–395.
Equity

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

vaccine among adolescents aged 12–15 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
87

EtR DomainQuestion

Work Group Judgments

Public Health 

Problem

Is COVID-19 disease among adolescents aged 12–15 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 Pfizer-BioNTech 

COVID-19 vaccine

What is the overall certainty of the evidence for the critical outcomes?

1 (high) for prevention of 

symptomatic COVID-19

4 (very low) for serious adverse events

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 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 

adolescents aged 12–15 years?

Yes

Resource Use

Is the Pfizer-BioNTech COVID-19 vaccine, given to adolescents aged 12–

15 years a reasonable and efficient allocation of resources?

Yes

Equity

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

given to adolescents aged 12–15 years on health equity?

Probably increased
88

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
89

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
90

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 
91

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

 Megan Wallace

 Julia Gargano

 Jessica MacNeil

 Heather Scobie

 Amy Blain

 Danielle Moulia

 Mary Chamberland

 Steve Hadler

 Nicole Reisman

 Megan Lindley

 Jack Gersten

 Eddie Shanley

 Epi Task Force:

– COVID-NET

– DVD Enhanced Surveillance

– Community Surveillance

– Seroprevalance

 MIS-C unit

 Data, Analytics and Visualization Task 

Force

 Respiratory Viruses Branch
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.