The Food and Drug Administration has issued the first emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in people 16 years old and older.
The Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to a press release issued by the agency.
The EUA allows for the distribution of the vaccine in the U.S.
According to the FDA, the current amount of data for the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) shows that the known and potential benefits for preventing COVID-19 outweigh the known and potential risks based off the use of the vaccine in millions of people 16 years old and older. The EUA comes off the heel of the FDA’s Vaccines and Related Biological Products Advisory Committee voting in favor of approving BNT162b2.
“The FDA’s authorization 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 M. Hahn, in a press release today. “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 tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
With BNT162b2 authorized by the FDA, The Centers for Disease Control (CDC) and Prevention’s Advisory Committee on Immunization Practices will now vote on recommending the vaccine, and who should receive it. Previously, the CDC recommended that health care providers and residents and staff of long-term care facilities should be the first to get it.
The vaccine will be administered as two doses, three weeks apart, and targets the SARS-CoV-2, virus that causes COVID-19 with a spike glycoprotein (S) antigen that is encoded by RNA and formulated in lipid nanoparticles (LNPs). This triggers the immune system to learn to react defensively to SARS-CoV-2 and build immunity to the virus without causing it.
The FDA reviewed data from 37,586 participants enrolled in a phase 3 double-blind placebo-controlled trial. In total, 18,801 participants received the vaccine and 18,785 received saline placebo. Participants were followed after two months. In a mid-November analysis, BCT162b2 had a 95% efficacy rate of preventing COVID-19 seven or more days after the second dose. Common low-grade side effects, that lasted a week, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. More people experienced the side effects after the second dose, but the FDA cautioned to expect these side effects after either dose.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research said in the release. “With science guiding our decision-making, the available safety and effectiveness data support the authorization 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.
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