The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BNT162b2 COVID-19 vaccine, developed by Pfizer and BioNTech.

“The FDA’s authorisation for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Dr Stephen Hahn. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.” 

The agency said it has determined that the vaccine has met the statutory criteria for issuance of an EUA, including:

• That there is clear evidence that the BNT162b2 vaccine may be effective in preventing COVID-19; and

• that the data suggests that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older.

In the announcement the FDA said that it can “assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information”.

“While not an FDA approval, today’s EUA of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States,” said Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorisation of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”

Vaccine safety

The safety data reviewed for the EUA included 37,586 of the participants enrolled in an ongoing randomised, placebo-controlled international study evaluating the efficacy and safety of the BNT162b2 vaccine. These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.

Vaccine efficacy

According to the FDA, the effectiveness data supporting the EUA includes an analysis of 36,523 participants in the trial. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95 percent effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA was issued to Pfizer Inc. The EUA will be effective until the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated – and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.