For more information: www.cdc.gov/COVID19

Clinical Considerations for

Pfizer-BioNTech COVID-19

Vaccination in Adolescents

Kate Woodworth, MD, MPH

May 12, 2021
Interim clinical considerations for COVID-19 vaccines

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 Recommendations apply to the use of the PfizerBioNTech, Moderna, and Janssen (Johnson & 

Johnson) COVID-19 vaccines under the Food and 

Drug Administration’s (FDA) Emergency Use 

Authorization (EUA)

 Clinical considerations are being updated to include 

guidance for adolescents and recommendations 

regarding vaccine coadministration and vaccination 

after Multisystem Inflammatory Syndrome in 

Children (MIS-C) and Adults (MIS-A)

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/index.html
Administration
Pfizer-BioNTech dosing and administration

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Authorized age groups ≥ 12 years

Number of doses in series 2 doses

Interval between 1st and 2nd doses* 3 weeks

Dose volume 0.3 ml

Route Intramuscular

*If it is not feasible to adhere to the recommended interval, the second dose may be administered up to 

6 weeks (42 days) after the first dose. 
Syncope (fainting)

 Syncope (fainting) may occur in association with any injectable vaccine. 

 Procedures should be in place to prevent falling injuries and manage 

syncopal reactions following COVID-19 vaccination.

 All people are recommended to be observed following COVID-19 

vaccination for at least 15 minutes; patients should be seated or lying down 

during the observation period to decrease the risk for injury should they 

faint. If syncope develops, patients should be observed until symptoms 

resolve.
Consent
Consent

 The federal government does not have specific requirements for medical 

consent for vaccination. 

 States/jurisdictions have medical consent laws that address the 

circumstances requiring and the processes for obtaining consent.

– These laws vary across jurisdictions. 

– Providers may also be subject to policy requirements for consent 

within their own organizations.

 Sites administering vaccines should follow current state/jurisdictional 

policies and practices for other routine immunizations in this age group. 
Coadministration
Coadministration

 Due to the novelty of the COVID-19 vaccines, the previous 

recommendation was to administer COVID-19 vaccines alone, with a 

minimum interval of 14 days before or after administration of any other 

vaccine to better understand any adverse reactions.

 However, substantial data have now been collected regarding the safety 

of COVID-19 vaccines currently authorized by FDA for use under EUA.

 Extensive experience with non-COVID-19 vaccines has demonstrated 

that immunogenicity and adverse event profiles are generally similar 

when vaccines are administered simultaneously as when they are 

administered alone.
Coadministration

 COVID-19 and other vaccines may now be administered without regard 

to timing. This includes simultaneous administration of COVID-19 and 

other vaccines on the same day, as well as co-administration within 14 

days.
Routine adolescent vaccines

 Updated coadministration recommendations may facilitate catch up 

vaccination of adolescents.

 As of May 2, 2021, overall VFC provider orders (other than influenza) are 

down by 11.7 million doses compared with 2019.

 This gap is largest in vaccines primarily given to adolescents.

– Tdap – down 18.9%

– HPV – down 19.3%

– Meningococcal conjugate vaccine – down 15.1%
Multisystem Inflammatory Syndrome in 

Children (MIS-C) and Adults (MIS-A)
Multisystem Inflammatory Syndrome in Children (MISC) and Adults (MIS-A)

 MIS-C and MIS-A are severe hyperinflammatory syndromes occurring 2-

6 weeks after acute SARS-CoV-2 infection, resulting in a wide range of 

manifestations and complications.

 The mechanisms of MIS-C and MIS-A are not well understood but 

include a dysregulated immune response to SARS-CoV-2. 
Clinical considerations for people with a history of 

MIS-C or MIS-A

 Children with MIS-C have high antibody titers to SARS-CoV-2; however, it 

is unknown if this correlates with protection against reinfection and for 

how long protective antibody levels persist.

 It is unclear if people with a history of MIS-C or MIS-A are at risk for 

recurrence of the same dysregulated immune response following 

reinfection with SARS-CoV-2 or in response to a COVID-19 vaccine.
Clinical considerations for people with a history of 

MIS-C or MIS-A

 People with a history of MIS-C or MIS-A may choose to be vaccinated.

 Considerations for vaccination may include:

– Clinical recovery from MIS-C or MIS-A, including return to normal cardiac 

function

– Personal risk of severe acute COVID-19 (e.g., age, underlying conditions)

– Level of COVID-19 community transmission and personal risk of reinfection

– Lack of safety data of COVID-19 vaccines following these illnesses

– Timing of any immunomodulatory therapies
Clinical considerations for people with a history of 

MIS-C or MIS-A

 Current evidence suggests that the risk of SARS-CoV-2 reinfection is low 

in the months after initial infection but may increase with time due to 

waning immunity. Thus, people with a history of MIS-C or MIS-A should 

consider delaying vaccination until they have recovered from illness and 

for 90 days after the date of diagnosis of MIS-C or MIS-A, recognizing 

that the risk of reinfection and, therefore, the benefit from vaccination, 

might increase with time following initial infection. 
Clinical considerations for people with a history of 

MIS-C or MIS-A

Healthcare personnel or health departments can request a consultation 

from the Clinical Immunization Safety Assessment COVIDvax project if they 

have complex COVID-19 vaccine safety questions not readily addressed by 

CDC guidance. 

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html
Contraindications and Precautions
Anaphylaxis

 Anaphylactic reactions 

have been rarely 

reported following 

receipt of COVID-19 

vaccines. 

 https://www.cdc.gov/

vaccines/covid19/downloads/Interm

Consid-Anaphylaxiscovid19-vaccinesites.pdf
Contraindications

 Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a 

component of the COVID-19 vaccine

 Immediate allergic reaction of any severity to a previous dose or known 

(diagnosed) allergy to a component of the vaccine

 Known polysorbate allergy is no longer a contraindication to mRNA 

vaccination but is a contraindication to Janssen COVID-19 vaccine and thus, 

a precaution to mRNA COVID-19 vaccination.
Observation period following vaccination

• History of immediate allergic reaction (any 

severity) to a vaccine or injectable therapy

• Contraindication to a different type of 

COVID-19 vaccine

• History of anaphylaxis (due to any cause)

All other persons

30 minutes 15 minutes 21
Additional resources
CDC Resources

Learn more with CDC’s COVID-19 vaccine tools and 

resources. Find information for COVID-19 vaccination 

administration, storage, reporting, patient education, 

and more.

• COVID-19 Vaccination: 

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

• For Healthcare Professionals: 

https://www.cdc.gov/vaccines/covid19/hcp/index.html

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 Engaging in Effective COVID-19 Vaccine 

Conversations – https://www.cdc.gov/vaccines/covid19/hcp/engaging-patients.htm

 Toolkit for Medical Centers, Clinics, 

and Clinicians

– https://www.cdc.gov/vaccines/covid19/health-systems-communicationtoolkit.html

COVID-19 vaccine communication resources

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Discussion
Discussion

 Does ACIP agree with the proposed clinical considerations 

related to vaccination?

 Are there any sections of the clinical considerations that ACIP 

would like to discuss?
Thank you