Summary Document for

Interim Clinical Considerations

for Use of COVID-19 Vaccines Currently Authorized or Approved in the United States

Category Pfizer-BioNTech Moderna Janssen

Replication-incompetent
Vaccine type mRNA mRNA
adenovirus type 26 vector

12 through 15 years of age (authorized)

Age groups ≥18 years ≥18 years
≥ 16 years (approved COMIRNATY)

Dose 30 µg 100 µg 5×1010 viral particles

Dose volume 0.3 ml 0.5 ml 0.5 ml

2 *
Number of doses in primary series 2* 1
(Booster dose recommended for certain people)†

Interval between doses 3 weeks (21 days) 1 month (28 days) N/A

All currently authorized or approved COVID-19 vaccines

ƒ Vaccines are not interchangeable. However, in exceptional situations, such as a contraindication to a second dose of mRNA vaccine or when a previous dose
Interchangeability of vaccines
product cannot be determined or is not available, interchangeability may be allowed (https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html).‡

ƒ COVID-19 vaccine and other vaccines may be administered on the same day, as well as any interval without respect to timing. When deciding whether to
Coadministration with
administer COVID-19 vaccine and other vaccines, providers should consider whether the patient is behind or at risk of becoming behind on recommended
other vaccines
vaccines, their risk of vaccine-preventable diseases (e.g., during an outbreak), and the reactogenicity profile of the vaccines.

Persons with prior or current ƒ COVID-19 vaccines can be given safely to people with prior SARS-CoV-2 infection
COVID-19 ƒ Defer vaccination until person has recovered from the acute illness and criteria have been met for them to discontinue isolation (https://www.cdc.gov/
coronavirus/2019-ncov/hcp/disposition-in-home-patients.html)

ƒ Can receive any FDA-authorized or approved vaccine but should be informed of risk of thrombosis with thrombocytopenia syndrome (TTS) after receipt
Women aged <50 years
of Janssen (Johnson & Johnson) COVID-19 Vaccine and the availability of other COVID-19 vaccine options

Persons who received monoclonal

antibodies or convalescent ƒ Defer vaccination for at least 90 days
plasma for COVID-19 treatment

ƒ People in community or outpatient setting should defer vaccination until quarantine period has ended (https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/
Persons with a known SARS-CoV-2 quarantine.html)
exposure ƒ Residents or patients in congregate settings may be vaccinated if they do not have symptoms consistent with COVID-19 (https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html)

History of heparin-induced
ƒ If within 90 days of illness, offer an mRNA vaccine, after 90 days vaccinate with any FDA-authorized or approved COVID-19 vaccine
thrombocytopenia (HIT)

09/29/2021 CS321571-W 1
 Summary Document for
Interim Clinical Considerations
for Use of COVID-19 Vaccines Currently Authorized or Approved in the United States

All currently authorized or approved COVID-19 vaccines

Persons with underlying conditions ƒ May receive COVID-19 vaccine

ƒ Can receive any FDA-authorized or approved COVID-19 vaccine
Persons with moderate to severe
• 1 dose Janssen COVID-19 Vaccine; currently no recommendation for an additional dose, or
immune compromise
• 2-doses of an mRNA COVID-19 vaccine; consider an additional dose at least 28 days after completion of the primary 2-dose series
ƒ If myocarditis or pericarditis occurred after a dose of an mRNA COVID-19 vaccine, should defer receiving a subsequent dose
Persons with a history of
• A subsequent dose can be considered in certain circumstances including personal risk of severe COVID-19 and level of community transmission.
myocarditis or pericarditis
ƒ If a history of myocarditis or pericarditis unrelated to an mRNA COVID-19 vaccination, may receive COVID-19 vaccine after the episode has completely resolved.
Persons with a history of Guillain-
ƒ Can receive any FDA-authorized or approved COVID-19 vaccine, however, discuss the availability of mRNA vaccines to offer protection against COVID-19
Barré Syndrome

Pregnant or breastfeeding people ƒ Are recommended to receive a COVID-19 vaccine, inform of risk of TTS after receipt of Janssen (Johnson & Johnson) COVID-19 Vaccine and the
or people trying to get pregnant availability of other options

ƒ Adolescents aged 12-17 are ONLY eligible for Pfizer-BioNTech COVID-19 Vaccine
Adolescents
ƒ Adolescents aged 18 years and older are eligible for all COVID-19 vaccines
ƒ Received all recommended doses of an FDA-authorized or approved COVID-19 vaccine, do not need additional doses
ƒ Received a non FDA-authorized or approved vaccine
• If vaccine is listed for emergency use by the World Health Organization (WHO) and received all recommended doses, do not need any additional
Persons vaccinated outside the
doses with an FDA-authorized or approved vaccine
United States
• If vaccine is listed for emergency use by WHO, but has not received all recommended doses, may be offered a complete FDA-authorized or
approved series
• If vaccine is not listed for emergency use by WHO, may be offered a complete FDA-authorized or approved COVID-19 vaccine series
ƒ Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to component of the COVID-19 vaccine
Contraindications
ƒ Immediate (within 4 hours of exposure) allergic reaction of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine
ƒ Immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies
Precaution
[excluding subcutaneous immunotherapy for allergies, i.e., “allergy shots”])

ƒ 30 minutes: persons with a precaution to vaccination (i.e., history of an immediate allergic reaction of any severity to a vaccine or injectable
Post-vaccination observation
therapy) and persons with a history of anaphylaxis due to any cause
periods
ƒ 15 minutes: all other persons
SARS-CoV-2 antibody testing ƒ Antibody testing not recommended for vaccine decision-making or to assess immunity following vaccination
*Consider an additional dose at least 28 days after the initial 2-dose primary series for people with moderate to severe immune compromise.
†
Administer a Pfizer-BioNTech booster dose at least 6 months after the primary series to people aged 65 or older, residents aged 18 and older in long-term care settings, people aged 50-64 with underlying medical conditions (https://www.cdc.gov/
coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html). Also a booster dose at least 6 months after primary series completion may be considered (based on individual benefits and risks) for people aged 18-49 years with
underlying medical conditions or aged 18-64 years at increased risk for SARS-CoV-2 exposure and transmission because of occupational or institutional settings.
‡
Although CDC provides considerations for a mixed series in exceptional circumstances (https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Interchangeability), this is still considered an administration error that
requires VAERS reporting
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