FDA Authorizes Pfizer As First COVID-19 Vaccine

The Food and Drug Administration (FDA) granted emergency use authorization to its first COVID-19 vaccine on Friday evening. The vaccine, developed by Pfizer Inc. and the German company BioNTech, will begin distribution shortly.

The news follows a much-anticipated public hearing on Thursday, during which an advisory panel to the FDA voted 17-4 in favor of the Pfizer vaccine’s authorization, with one abstention.

Pfizer presented data from clinical trials involving 43,000 adult participants. Earlier this week, the FDA shared some of that data, including the fact that 95% of people in the clinical trial who received the vaccine did not go on to develop COVID-19. Side effects were minor, including chills, mild pain, and redness at the injection site. 

The emergency use authorization (EUA) applies to people age 16 and older. Pfizer is also conducting clinical trials on the safety and efficacy of the vaccine in children as young as 12, and is expected to add trials for younger children as well. 

Safety and Efficacy Data From More Populations Still Needed 

The FDA advisory panel, called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommends Pfizer take additional measures to make sure its vaccine is safe and effective for more populations. The panel advises more people of color be added to ongoing clinical trials. People of color have been more likely than White people to both contract COVID-19 and to die of the virus.

The panel also discussed two reported cases of allergic reactions in people who received vaccine in the U.K. this week, where it has already been approved. Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, asked Pfizer presenters about the allergic reactions, concerned that people with severe allergies may choose not to take the vaccine. Offit recommended that studies also be conducted on the vaccine in people with common allergies. 

The U.K. is recommending that people with a history of anaphylaxis to a medicine or food not get the vaccine. The U.S. may add a similar warning in tandem with authorization. FDA staffers at the meeting told the panel they were already working on written documentation for consumers about the safety and effectiveness of the vaccine.

Following the VRBPAC decision, FDA commissioner Stephen M. Hahn, MD issued a statement: 

“Normally, the review process for vaccines studied in tens of thousands of people takes months. Even though the process has been expedited in association with the review of this EUA, the FDA’s expert review staff has reviewed thousands of pages of technical information [including] clinical trial data, non-clinical data on the development of the vaccine in the lab, and manufacturing data on how the vaccine is made.” 

Hahn, likely seeking to allay fears among consumers, added: “In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process. However, they know that they must carry out their mandate to protect the public health and to ensure that any authorized vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect.” 

President-elect Joe Biden also issued a statement after the committee vote saying, “the integrity of science led us to this point.” 

The FDA says that distribution of vaccines could come within 24 hours of authorization. 

The FDA advisory committee will review a second COVID-19 vaccine, made by Moderna, on Thursday, December 17.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.