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Issue 1,537: December 14, 2020

FDA issues EUA for Pfizer-BioNTech mRNA vaccine; ACIP votes to recommend the vaccine for persons 16 years of age and older

* FDA issues EUA for Pfizer-BioNTech mRNA vaccine after its advisory committee vote; fact sheets published

* ACIP recommends first COVID-19 vaccine for use in U.S.; IAC summarizes guidance from December 11–12 meeting

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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 ([link removed]) and the Fact Sheet for Healthcare Providers ([link removed]). That second 29-page document contains 10 pages of information and product-handling graphics plus 19 pages of the product’s prescribing information.

Related Links
* Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Potential Recipients and Caregivers ([link removed]) (6 pages)
* Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers ([link removed]) (29 pages)
* FDA’s Letter of EUA Authorization ([link removed])
* FDA’s COVID-19 Vaccines ([link removed]) gateway page
* FDA’s Emergency Use Authorization for Vaccines Explained ([link removed]) web page
* FDA’s documents from December 10 VRBPAC meeting ([link removed])
* FDA’s Vaccine Development 101 ([link removed])
* FDA's Vaccine Facts: The Path for a COVID-19 Vaccine from Research to EUA ([link removed])
* Pfizer's Press Release ([link removed]) : U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older (12/12/20)
* Examples of Pfizer-BioNTech COVID-19 Vaccine package labeling ([link removed])

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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 ([link removed]) the Advisory Committee on Immunization Practices ([link removed]) 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) ([link removed]) 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 ([link removed]) in the Morbidity and Mortality Weekly Report (MMWR) Early Release issued on December 13 ([link removed]).

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.

Related Links
* The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—United States, December 2020 ([link removed]), MMWR Early Release and HTML version ([link removed])
* ACIP Presentation Slides: December 11–12, 2020 ([link removed]) meeting gateway page
* MMWR: ACIP’s Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020 ([link removed])
* CDC’s COVID-19 Vaccination ([link removed]) gateway page
* CDC’s COVID-19 Vaccine Training Module for Providers ([link removed])
* CDC’s Answering Your Questions about the New COVID-19 Vaccines ([link removed]) (PDF)
* CDC’s Healthcare Professionals: Preparing for COVID-19 Vaccination ([link removed])
* CDC’s COVID-19 Vaccination Communication Toolkit ([link removed])
* CDC’s COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals ([link removed]) (PDF)
* Pfizer-BioNTech’s Fact Sheet for Vaccination Providers ([link removed]) (PDF)
* Pfizer-BioNTech’s Fact Sheet for Recipients and Caregivers ([link removed]) (PDF)
* Pfizer-BioNTech’s Global Information about Pfizer-BioNTech COVID-19 Vaccine ([link removed])


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Editorial Information

Editor
Deborah L. Wexler, MD ([email protected])

Associate Editors
John Grabenstein, RPh, PhD ([email protected])
Sharon Humiston, MD, MPH ([email protected])

Consulting Editors
Taryn Chapman, MS ([email protected])
Marian Deegan, JD ([email protected])
Courtnay Londo, MA ([email protected])

Technical Editor
Liv Augusta Anderson, MPP ([email protected])

About IAC Express
The Immunization Action Coalition welcomes redistribution of this issue of IAC Express or selected articles. When you do so, please add a note that the Immunization Action Coalition is the source of the material and provide a link to this issue ([link removed]).

IAC Express is supported in part by Grant No. 6NH23IP922550 from the National Center for Immunization and Respiratory Diseases, CDC. Its contents are solely the responsibility of IAC and do not necessarily represent the official views of CDC.

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