cdc.gov/coronavirus

Interim Clinical Considerations 

for COVID-19 Vaccine in 

Children Ages 5–11 Years

Kate Russell Woodworth, MD, MPH, FAAP

ACIP Meeting

November 2, 2021
Outline of Presentation

 The Pfizer-BioNTech COVID-19 Vaccine for children ages 5–11 years

– Formulation and dosing

 Vaccine recipients

– Underlying medical conditions

– Prior SARS-CoV-2 infection

– Children with a history of MIS-C

 Patient and parent/guardian counseling

 Vaccine administration

– Coadministration

– Administration errors
Pfizer-BioNTech COVID-19 Vaccine 

Formulation and Dosing in Children Ages 

5–11 years
Formulation and Dosing for Pfizer-BioNTech COVID-19 

Vaccines

Formulation for 

≥12-year-olds (purple cap)

Formulation for 

5–11-year-olds (orange cap)

Age group 12 years and older 5-11 years

Vial cap color

Dose (mRNA concentration) 30 ug 10 ug

Injection volume 0.3 mL 0.2 mL

Fill Volume 

(before dilution) 0.45 mL 1.3 mL

Amount of Diluent* 

Needed per vial 1.8 mL 1.3 mL

Doses per Vial 6 (after dilution) 10 (after dilution)

*Diluent: 0.9% sterile Sodium Chloride Injection, USP (non-bacteriostatic; DO NOT USE OTHER DILUENTS)

Modified from https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-Reference-Planning.pdf
Formulation and Dosing for Pfizer-BioNTech COVID-19 

Vaccines

Formulation for 

≥12-year-olds (purple cap)

Formulation for 

5–11-year-olds (orange cap)

Storage conditions

Ultralow temperature freezer 

(-90°C to -60°C) 9 months 6 months

Freezer (-25°C to -15°C) 2 weeks N/A

Refrigerator (2°C to 8°C) 1 month 10 weeks

Modified from https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-Reference-Planning.pdf
Formulation and Dosing for Pfizer-BioNTech COVID-19 

Vaccines

Formulation for 

≥12-year-olds (purple cap)

Formulation for 

5–11-year-olds (orange cap)

Number of doses 2 2

Interval 3 weeks 

(21 days)

3 weeks 

(21 days)

Additional primary dose Moderate and severe 

immunocompromise Not recommended

Booster dose

Not recommended 12–17 years 

Not recommended

Recommended for certain 

groups ≥18 years*

*Individuals 65 years and older or individuals ages 18 years and older who live in long-term care settings, have underying medical conditions, or who work or live in highrisk settings. Mbaeyi S, Oliver SE, Collins JP, et al. The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster 

Doses of COVID-19 Vaccines — United States, 2021. MMWR Morb Mortal Wkly Rep. ePub: 29 October 2021
Vaccine Dosage

 Children should receive the age-appropriate vaccine formulation 

regardless of their size or weight.

– As opposed to many medications, vaccine dosages are based on age and not 

size or weight.

 The dosage should be based on the child’s age on the day of vaccination.

– If a child turns from 11 to 12 years of age in between their first and second 

dose and receives 5–11 years 10 μg (orange cap) for their second dose, they 

do not need to repeat the dose and this is not considered an error per the 

EUA.
Vaccine Recipients
Underlying Medical Conditions

 Children with underlying medical conditions may be at increased risk for 

severe illness from COVID-191, however, severe COVID-19 can occur in 

children with and without underlying medical conditions.

 COVID-19 primary vaccination would be recommended for everyone ages 5 

years and older, regardless of underlying medical conditions.

1https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#ChildrenAndTeens

2https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Current or Prior SARS-CoV-2 Infection

 People with known current SARS-CoV-2 infection should defer vaccination 

at least until the person has recovered from the acute illness (if the person 

had symptoms) AND they have met criteria to discontinue isolation1.

– Isolation and precautions can typically be discontinued 10 days after positive test if 

asymptomatic or 10 days after symptom onset and after resolution of fever for at least 

24 hours) 

 Serologic testing to assess for prior infection is not recommended for the 

purpose of vaccine decision-making2. 

1 https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html

2https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
Prior SARS-CoV-2 Infection

 COVID-19 primary vaccination would be recommended for everyone ages 5 

years and older, regardless of a history of symptomatic or asymptomatic 

SARS-CoV-2 infection or seropositivity.

 >7 million adolescents ages 12–15 years have been fully vaccinated with 

Pfizer-BioNTech COVID-19 Vaccine in the United States1 and in the general 

population there has been no safety concerns associated with vaccination 

of those who had prior infection.

1https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic
Prior SARS-CoV-2 Infection

Data from clinical trials in children ages 5–11 years indicate that the Pfizer-BioNTech 

COVID-19 Vaccine can be given safely to those with evidence of a prior SARS-CoV-2 

infection.

Current evidence suggests that protection from reinfection is high after initial 

infection but decreases with time due to waning immunity.

Substantial heterogeneity exists in individual immune response to infection, and in 

adults, asymptomatic infection leads to lower antibody levels.

Growing epidemiologic evidence from adults and adolescents indicates that 

vaccination following infection increases protection from subsequent infection, 

including in the setting of more infectious variants.

Dan 2021, Science: https://doi.org/10.1126/science.abf4063; Cavanaugh 2021, MMWR; 70(32):1081-3. Lumley 2021; Clin Infect Dis; doi: 10.1093/cid/ciab608. Gazit

2021, medRxiv; https://doi.org/10.1101/2021.08.24.21262415. Shenai 2021, medRxiv; https://doi.org/10.1101/2021.09.12.21263461. 
Limitations of Antibody Testing

 Antibody tests cannot determine when a person was infected.

 Antibody tests greatly vary in their sensitivity, particularly >3 months after 

infection.

 People can test positive on commercial antibody tests even after other 

markers of immunological response, such as neutralizing antibodies, have 

waned.

 At this time, there is no FDA-authorized or approved test that providers or 

the public can use to reliably determine whether a person is protected 

from infection.
Vaccination of Children with a History of Multisystem 

Inflammatory Syndrome in Children (MIS-C)

 The benefits of COVID-19 vaccination for children and adolescents with a 

history of MIS-C are likely to outweigh a theoretical risk of an MIS-like illness 

or the known risks of COVID-19 vaccination for people who meet all of the 

following criteria: 

1) Clinical recovery has been achieved, including return to normal cardiac function; 

2) It has been ≥90 days since their diagnosis of MIS-C; 

3) They are in an area of high or substantial community transmission of SARS-CoV-2, or 

otherwise have an increased risk for SARS-CoV-2 exposure and transmission; 

4) Onset of MIS-C occurred before any COVID-19 vaccination. 
Vaccination of Children with a History of Multisystem 

Inflammatory Syndrome in Children (MIS-C)

 COVID-19 vaccination may also be considered for children with a history of 

MIS-C who do not meet all the prior criteria. 

 Experts view clinical recovery, including return to normal cardiac function, 

an important factor when considering COVID-19 vaccination. 

 Additional factors when considering individual benefits and risks may 

include:

1) An increased personal risk of severe COVID-19 (e.g., age, underlying conditions)

2) Timing of immunomodulatory therapies
Children Diagnosed with MIS-C after COVID-19 

Vaccination

 In the rare instance a person develops MIS-C or a similar clinical illness after 

receipt of a COVID-19 vaccine, referral to a specialist should be considered.

 Because MIS-C is a condition known to occur with SARS-CoV-2 infection, 

these individuals should be assessed for laboratory evidence of current or 

prior SARS-CoV-2 infection.

Any cases should be reported to Vaccine Adverse Event Reporting System (VAERS) 

https://vaers.hhs.gov/reportevent.html

Consultation from Clinical Immunization Safety Assessment Project is available 

http://www.cdc.gov/vaccinesafety/Activities/CISA.html
Counseling
Counseling: Expected Side Effects from PfizerBioNTech COVID-19 Vaccine

 Children may experience fewer side effects than adolescents or young adults1.

 Children with evidence of prior infection may have fewer side effects than those 

without evidence of prior infection1.

 Expected side effects include

– Local: pain, swelling, erythema at the injection site

– Systemic: fever, fatigue, headache, chills, myalgia, arthralgia, lymphadenopathy

 Routine antipyretic or analgesic medications can be taken for the treatment of postvaccination local or systemic symptoms, if medically appropriate. 

– In general, Aspirin is not recommended for use in children and adolescents ≤18 

years due to risk of Reye’s syndrome. 

1https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Counseling: Possible Risk of Myocarditis

 Myocarditis and/or pericarditis have occurred rarely in some people 

following receipt of mRNA COVID-19 vaccines, typically within a few days 

following receipt of the second dose.

 The observed risk is highest in males 12–29 years of age1. 

 The risk of myocarditis or pericarditis after receipt of an mRNA COVID-19 

vaccine is lower than the risk of myocarditis associated with SARS-CoV-2 

infection in adolescents and adults2.

1Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory 

Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal Wkly Rep 2021;70:977–982. 

DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2 2Boehmer TK, Kompaniyets L, Lavery AM, et al. Association Between COVID-19 and Myocarditis Using Hospital-Based Administrative Data — United States, March 

2020–January 2021. MMWR Morb Mortal Wkly Rep 2021;70:1228–1232. DOI: http://dx.doi.org/10.15585/mmwr.mm7035e5
Counseling: Possible Risk of Myocarditis

 No cases of myocarditis or pericarditis were reported in clinical trial for 

children ages 5–11 years (n=3,082), although the study was not powered to 

assess the risk of myocarditis1.

 The baseline risk of myocarditis is much higher in adolescents ages 12–17 

years compared to children ages 5–11 years. 

1https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Counseling: Possible Risk of Myocarditis

 FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine in children ages 

5–11 years based on the determination that the benefits of COVID-19 

vaccination outweigh risks in this population.

 People receiving mRNA COVID-19 vaccines, especially males ages <30 years, 

should be made aware of the possibility of myocarditis or pericarditis 

following receipt of mRNA COVID-19 vaccines.

– Seek care for symptoms of

• Chest pain

• Shortness of breath

• Feelings of having a fast-beating, 

fluttering, or pounding heart

Any cases should be reported to VAERS 

https://vaers.hhs.gov/reportevent.html
Administration
Coadministration

 COVID-19 vaccines may be administered without regard to timing of other 

vaccines. This includes simultaneous administration of COVID-19 vaccine 

and other vaccines on the same day.

 If multiple vaccines are administered at a single visit, administer each 

injection in a different injection site, according to recommendations by 

age1.

– Separate injection sites by 1 inch or more.

– For older children (≥11 years), the deltoid muscle can be used.

– For younger children (5–10 years), if more than 2 vaccines are injected in a single limb, 

the vastus lateralis muscle of the anterolateral thigh is the preferred site because of 

greater muscle mass.

1https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
Administration Errors

 Formulations of the Pfizer-BioNTech COVID-19 Vaccines are NOT

interchangeable.

 If a child ages 5–11 years inadvertently receives a 30 μg dose for their 

first dose, they should receive a single age-appropriate 10 μg dose for 

their second dose 21 days later and should be considered as having a 

completed primary series. 

 If a child ages 5–11 years inadvertently receives a 30 μg dose for their 

second dose, they should be considered has having a completed primary 

series.
Administration Errors

 If an individual aged ≥12 years inadvertently receives a 10 μg dose, the 

dose should be repeated with the age appropriate 30 μg dose immediately.

– Exception for children who turned from 11 to 12 years in between their first and second 

dose and receive a second 10 μg dose to complete their series.

 Due to the rare risk of myocarditis, males aged <30 years may consider 

waiting 21 days (the recommended interval) after the erroneous dose to 

repeat the dose. 
Administration Errors

 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-

vaccines-us.html
Additional Clinical 

Resources

Updates will be posted at:

https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html

https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html
Acknowledgements

 Sujan Reddy

 Mary Chamberland

 Sara Oliver

 Kathleen Dooling

 Sarah Mbaeyi

 Rachel Gorwitz

 Matthew Oster

 Jefferson Jones

 COVID-19 Response Epidemiology 

Task Force

 CISA

– Karen Broder

– Margaret Cortese

 Immunization Services Division

– JoEllen Wolicki

– Valerie Morelli

– Elisha Hall

– Andrew Kroger
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.
Back up slides
Administration Sites

Age Needle length Injection site

3-10 years

5⁄8–1“1 Deltoid muscle of arm(preferred) 

1–11⁄4" Vastus lateralis muscle of

anterolateral thigh (alternative)

11-18 years

5⁄8–1“1 Deltoid muscle of arm(preferred) 

1–11⁄2" Vastus lateralis muscle of

anterolateral thigh (alternative)

1 A 5/8"needle may be used in newborns, preterm infants, and patients weighing less than 130 lbs (<60 kg) for IM injection in the deltoid muscle only 

if the skin is stretched tight, the subcutaneous tissue is not bunched, and the injection is made at a 90-degree angle to the skin.

https://www.cdc.gov/vaccines/hcp/admin/downloads/vaccine-administration-needle-length.pdf
Triage of persons Presenting for COVID-19 Vaccination

* For additional information please see https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

CONTRAINDICATION TO VACCINATION 

ALLERGIES

History of the following:

• Severe allergic reaction (e.g., anaphylaxis) after a 

previous dose or to component of the vaccine

• Known (diagnosed) allergy to a component of 

the vaccine

ACTIONS

• Do not vaccinate.

• Consider referral to allergist-immunologist.

• Consider other vaccine alternative if age 

appropriate.

PRECAUTION TO VACCINATION 

ALLERGIES

Among people without a contraindication, a history 

of: 

• Any immediate allergic reaction to other 

vaccines (non-COVID-19) or injectable 

therapies

• Non-severe, immediate (onset <4 hours) allergic 

reaction after a previous dose of a COVID-19 

vaccine

Note: people with a contraindication to mRNA 

COVID-19 vaccines have a precaution to Janssen 

COVID-19 vaccine, and vice versa. 

ACTIONS

• Risk assessment

• 30-minute observation period if vaccinated

• Consider referral to allergist-immunologist

MAY PROCEED WITH VACCINATION 

ALLERGIES

Among persons without a contraindication or 

precaution, a history of: 

• Allergy to oral medications, including 

anaphylaxis (including the oral equivalent of an 

injectable medication)

• History of food, pet, insect, venom, 

environmental, latex, etc., allergies, including 

anaphylaxis

• Family history of allergies

ACTIONS

• 30-minute observation period: Persons with a 

history of anaphylaxis (due to any cause)

• 15-minute observation period: All other persons
Appendix B: Triage of people presenting for COVID-19 vaccination

CONTRAINDICATION TO VACCINATION PRECAUTION TO VACCINATION MAY PROCEED WITH VACCINATION

• History of the following:

• Severe allergic reaction (e.g., 

anaphylaxis) after a previous dose 

or to component of the vaccine

• Immediate allergic reaction* of 

any severity after a previous dose 

or known (diagnosed) allergy to a 

component of the vaccine

• Among people without a 

contraindication, a history of:

• Any immediate allergic reaction*

to other vaccines (non-COVID-19)

or injectable therapies

• Non-severe, immediate (onset <4 

hours) allergic reaction after a previous 

dose of of COVID-19 vaccine 

Note: people with a contraindication to mRNA 

COVID-19 vaccines have a precaution to Janssen 

COVID-19 vaccine, and vice versa. 

• Among people without a 

contraindication or precaution, a history 

of:

• Allergy to oral medications (including the 

oral equivalent of an injectable 

medication)

• History of food, pet, insect, venom, 

environmental, latex, etc., allergies

• Family history of allergies

• Actions:

• Do not vaccinate.

• Consider referral to allergistimmunologist.

• Consider other vaccine alternative.

• Actions:

• Risk assessment

• 30-minute observation period if 

vaccinated

• Consider referral to allergistimmunologist

• Actions:

• 30-minute observation period: people 

with history of anaphylaxis (due to any 

cause)

• 15-minute observation period: all other 

people

Triage of persons Presenting for COVID-19 Vaccination