FDA Grants EUA for Pfizer/BioNTech COVID-19 Vaccine

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On Friday evening the FDA granted Pfizer and BioNTech an emergency use authorization (EUA) for their messenger RNA (mRNA)-based BNT162b2 COVID-19 vaccine, making it the first vaccine available for use in the United States.

The companies plan to begin distributing this week the first vials of BNT162b2, a two-dose vaccine that is indicated for the prevention of COVID-19 in individuals 16 years of age and older.

“As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic,” Pfizer Chairman and CEO Albert Bourla, DVM, Ph.D., said in a statement. “We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”

Washington plans to ship an initial 2.9 million doses this coming week, Gen. Gustave Perna, chief operating officer of Operation Warp Speed—the Trump administration’s effort to advance R&D, manufacturing, and distribution of COVID-19 vaccines—told reporters on Wednesday.

Those doses are among 6.4 million doses said a few days ago to have been available to the United States. Of the remainder, 500,000 will be held in reserve by the U.S. government, and the rest will be shipped in three weeks when the first patients are due for their second dose.

Speaking at the Milken Institute’s 2020 Future of Health Summit on Wednesday, Alex Azar II, Secretary of Health and Human Services, said Wednesday the Trump administration aims to have 20 million Americans begin receiving the vaccine this month, and at least 50 million by the end of January.

“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,” stated FDA Commissioner Stephen M. Hahn, M.D.

The FDA’s approval followed months of intense pressure on the agency and Hahn to act quickly on the companies’ EUA application from President Trump—pressure that he intensified on Friday morning with a tweet faulting what he contended was the agency’s overly slow response to the Pfizer and BioNTech EUA application for BNT162b2, submitted November 20.

“It is still a big slow turtle,” Trump said of the FDA, demanding of Hahn: “Get the dam[n] vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!”

National news outlets, led by The Washington Post, followed by reporting that Trump’s chief of staff Mark Meadows directed Hahn to have BNT162b2 approved by the end of Friday, or else start looking for another job. Hahn denied the Post’s report, which was attributed to unnamed sources.

The EUA makes the United States the fifth country to approve BNT162b2. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) acted first among global regulatory agencies on November 30 when it granted temporary authorization to the Pfizer/BioNTech vaccine. That apparently rankled President Donald Trump enough for Meadows to summon Hahn to the White House last week.

Since the U.K. authorization, Bahrain, Canada, and Saudi Arabia have authorized either emergency or permanent approvals for BNT162b2.

The FDA set the stage for granting the Pfizer/BioNTech EUA application yesterday when the agency’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) recommended that BNT162b2 be authorized for emergency use, by a 17-4 vote with one abstention. The panel agreed that based on the totality of scientific evidence available, the benefits of BNT162b2 outweighed its risks for use in individuals 16 years of age and older.

“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,” Hahn added.

BNT162b2 is among 20 “Front Runner” candidates among the more than 300 COVID-19 therapeutics under study in GEN’s “COVID-19 Drug & Vaccine Candidate Tracker.”

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