Technically Speaking: FDA Issues EUA for Pfizer-BioNTech mRNA Vaccine; CDC Approves Its Use and Provides Clinical Guidance

On Dec. 11, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States for use in people 16 years of age and older.

The Advisory Committee on Immunization Practices (ACIP) met on Dec. 11–12 and voted to recommend the use of Pfizer’s mRNA vaccine in people 16 years of age and older, and on Dec. 13, CDC published ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—U.S., December 2020 as a Morbidity and Mortality Weekly Report (MMWR) Early Release.

While MMWR publications should always be consulted for official guidance, additional highlights of ACIP’s clinical guidance discussed at the committee’s Dec. 11–12 meeting are provided below:

• Administration — The Pfizer-BioNTech COVID-19 vaccine is administered intramuscularly as a two-dose series separated by 21 days. Although the 21-day separation should be followed as closely as possible, the standard four-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.
• People with a history of SARS-CoV-2 infection or exposure — People 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 people with a known SARS-CoV-2 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, people 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.

Several key resources from FDA and CDC are listed below. CDC is updating COVID-19 information on its webpages frequently.

From FDA

• Fact Sheet for Recipients and Caregivers
• Fact Sheet for Healthcare Providers Administering Vaccine

From CDC

• “The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—U.S. December 2020”
• “ACIP’s Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—U.S., 2020”
• Interim Considerations for COVID-19 Vaccination of Healthcare Personnel and Long-Term Care Facility Residents
• COVID-19 Vaccination
• COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians