The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Pfizer and BioNTech’s mRNA vaccine, BNT162b2, for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older.
The EUA was based on data from an ongoing phase 3 double-blind, placebo-controlled study in approximately 44,000 participants. Final efficacy data, which included 36,523 participants, showed that the vaccine was 95% effective (P <.0001) in people without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as well as in those with or without evidence of infection before vaccination, based on the breakdown of cases in the BNT162b2 (n=8) and placebo arms (n=162). The data also included 10 severe cases, 9 of which occurred among participants in the placebo group.
Additional data from the trial will be collected and used to prepare the Biologics License Application for full regulatory approval, which is expected to be submitted to the FDA in 2021. Following the announcement of the EUA, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the vaccine, prioritizing use in health care personnel and residents in long-term care facilities.
The first batches of the vaccine are currently being shipped across the country; the allocation and distribution is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services, including the CDC.
The BNT162b2 vaccine is administered intramuscularly as a 2-dose series (0.3mL each) spaced 21 days apart. Patients who receive the Pfizer-BioNTech COVID-19 vaccine should receive a second dose of the same vaccine to complete the series; there are currently no data available on the interchangeability of COVID-19 vaccines. The preservative-free product is supplied as a multi-dose vial that contains 5 doses; the frozen suspension requires thawing and diluting prior to administration and must be used within 6 hours of dilution.
As part of the EUA, a summary of instructions and important safety information is detailed in a fact sheet for health care providers. Following administration, adverse reactions that have been reported in clinical trials included injection site pain, swelling and redness, fatigue, headache, muscle and joint pain, chills, fever, nausea, malaise, and lymphadenopathy. Additionally, there have been reports of severe allergic reaction during mass vaccination outside of clinical trials; appropriate medical treatment used to manage allergic reactions should be immediately available in settings where the vaccine will be administered.
For more information visit fda.gov.
1. Pfizer and BioNTech celebrate historic first authorization in the U.S. of vaccine to prevent COVID-19. [press release]. December 11, 2020.
2. U.S. CDC committee of independent health experts recommends vaccination with Pfizer and BioNtech COVID-19 vaccine for persons ages 16 years and older. [press release]. December 12, 2020.