WASHINGTON — The FDA granted emergency use authorization (EUA) to Pfizer’s mRNA-based Covid-19 vaccine, a crucial step towards defeating the virus that has killed nearly 300,000 in the U.S. alone.
This decision followed by one day a vote by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) to recommend emergency authorization for the vaccine.
BNT162b2, developed by Pfizer Inc. and the German-based BioNTech, is approved for use SARS-CoV-2 in patients ages 16 years and older—and, if public health officials adhere to the CDC Advisory Committee on Immunization Practices (ACIP) recommendation, the first doses should be available to healthcare workers and residents of long-term care facilities early next week, with second doses following approximately 3 weeks later.
“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 Stephen M. Hahn, MD, in a statement. “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.”
This authorization came on Dec. 11 after White House Chief of Staff Mark Meadows allegedly told Hahn to clear the Pfizer vaccine by end of day Friday or submit his resignation, according to individuals familiar with the situation who spoke on the condition of anonymity, The Washington Post reported. Hahn later dismissed these reports in a statement, calling it an “untrue representation” of his discussion with the Chief of Staff.
While Pfizer and BioNTech did not receive funding from Operation Warp Speed for vaccine research and development, the manufacturers have arranged a $1.95 billion contract with the federal government to receive 100 million doses of the vaccine, roughly 25 million of which should be delivered by the end of the month—federal officials noted that distribution of the first 2.9 million doses would begin within 24 hours of issuance of the EUA.
This EUA authorization was based on results from an ongoing randomized, placebo-controlled, phase III trial, as previously reported by BreakingMED. The FDA received safety data on 37,586 trial participants, 18,801 of whom received the vaccine and 18,785 received placebo.
“The vaccine was 95% 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,” the agency explained. “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 most commonly reported side effects of the vaccine — which typically lasted several days — were injection site pain, fatigue, headache, muscle pain, chills, joint pain, and fever. Side effects were more common following administration of the second dose, the FDA noted.
In a press release announcing the authorization, Pfizer added that BNT162b2 should not be administered to individuals with a known history of severe allergic reaction to any component of the vaccine, and that appropriate medical treatment to manage allergic reactions must be immediately available in the event of an acute anaphylactic reaction following vaccination — this advice comes on the heels of reports from the U.K. of severe allergic reactions in two healthcare workers who received the Pfizer vaccine earlier this week. The vaccine is also not currently indicated for individuals younger than 16, and Pfizer noted that additional studies are planned to evaluate BNT162b2 in pregnant women, children, and people in special risk groups, such as the immunocompromised.
In order to keep its EUA, Pfizer Inc. is required to report “all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of Covid-19 that result in hospitalization or death” to the Vaccine Adverse Event Reporting System (VAERS).
John McKenna, Associate Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,730,933,31,926,561,927,151,725,928,925,934
