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FDA issues EUA for Pfizer-BioNTech mRNA vaccine after its advisory committee
vote; fact sheets published
On December 11, the Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for a vaccine to help prevent COVID-19
caused by SARS-CoV-2 virus in people 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2) to
be distributed in the United States.
FDA’s action aligns with the recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which determined on
December 10 that the totality of scientific evidence available indicates that the benefits of vaccination with the Pfizer-BioNTech COVID-19 vaccine
outweigh its risks for use in people 16 years or older.
Below appear links to technical and supportive documents related to this vaccine and the EUA. Most relevant to vaccinators are the Fact Sheet for Potential Recipients and Caregivers and the Fact Sheet for Healthcare Providers. That second 29-page document contains 10 pages of information and
product-handling graphics plus 19 pages of the product’s prescribing information.
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ACIP recommends first COVID-19 vaccine for use in U.S.; IAC summarizes
guidance from December 11–12 meeting
After holding nine formal meetings since June and hearing more than 70 presentations on COVID-19 vaccine, on December 12 the Advisory Committee on Immunization Practices voted to recommend the use of the
Pfizer-BioNTech COVID-19 vaccine for persons 16 years of age and older in the United States. This historic vote followed issuance of the Food and Drug
Administration’s Emergency Use Authorization (EUA) for the vaccine on December 11 [see story above].
The ACIP recommendations and additional guidance for the vaccine’s use became official when adopted by CDC and published as ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—U.S, December 2020 in the Morbidity and Mortality Weekly Report (MMWR) Early Release issued on December 13.
While the MMWR publication should always be consulted for official guidance, additional highlights of ACIP’s clinical guidance
discussed at the committee’s December 11–12 meeting are provided below:
- Administration – The Pfizer-BioNTech COVID-19 vaccine is administered intramuscularly as a 2-dose series
separated by 21 days. Although the 21-day separation should be followed as closely as possible, the standard 4-day grace period (allowing a
17–20 day interval between doses) is acceptable. If more than 21 days elapse between doses, vaccine should be administered at the earliest
opportunity, but doses do not need to be repeated due to a longer interval. Both doses are necessary for protection. COVID-19 vaccines are not
interchangeable, and care should be taken to ensure the same vaccine is used for both doses. However, if different mRNA vaccines are inadvertently
administered, no additional doses of either vaccine are recommended at this time. A minimum interval of 14 days should be maintained before or after
administration of this COVID-19 vaccine with any other type of vaccine.
- Persons with a history of SARS-CoV-2 infection or exposure – Persons should be offered vaccine regardless of a
prior history of infection. However, if they are currently infected, vaccination should be deferred until their recovery from acute illness. To avoid exposure
to healthcare personnel, vaccination should be deferred for persons with a known SARS-CoV2 exposure until after their quarantine period has ended, with
the exception of those who live in congregate settings (e.g., long-term care, correctional facilities, homeless shelters). Vaccination should be deferred for
90 days following receipt of monoclonal antibodies or convalescent plasma used as part of COVID-19 treatment.
- Special populations – Unless otherwise contraindicated, persons with underlying medical conditions or who are
immunocompromised may receive COVID-19 vaccine. Pregnant or lactating women may choose to be vaccinated after discussion with their healthcare
provider to assess their risk of infection, to make an informed decision. Routine testing for pregnancy before vaccination is not recommended.
- Patient vaccine counseling – All patients should be counseled about the importance of receiving both doses of
vaccine, as well as expected local and systemic post-vaccination symptoms.
- Interpretation of SARS-CoV-2 test results in a vaccinated person – Prior receipt of vaccine will not affect results of
viral tests. Vaccination could affect anti-spike antibody test results, but not antibody tests based on nucleocapsid.
ACIP also voted to add descriptive text and a link to current COVID-19 vaccine recommendations within the 2021 U.S. Adult and Child/Adolescent
Immunization Schedules, which will be published in February.
CDC is updating the COVID-19 information on its web pages frequently, with several key resources listed below.
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