FDA chief says agency will quickly approve Pfizer’s Covid vaccine for emergency use

The Food and Drug Administration is “rapidly” working toward clearing Pfizer’s Covid-19 vaccine for emergency use after a key panel overwhelmingly endorsed the shots Thursday evening, Commissioner Stephen Hahn said in a statement Friday.

“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” Hahn and Marks said.

Hahn added in a tweet that the FDA “is finalizing the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine.”

The FDA’s comments come after the FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday voted 17 to 4 with one abstention to recommend the vaccine, which the company developed alongside BioNTech, for emergency authorization. The FDA typically follows the advisory committee’s recommendations, but it’s unusual for the agency’s commissioner to announce the intent to clear the product ahead of the announcement.

Data on Pfizer’s vaccine shows it was around 95% effective in preventing Covid-19 among trial participants. The FDA is expected to authorize its emergency use as early as Friday.

The authorization of the vaccine should come “in the next couple of days,” Alex Azar, secretary of the Department of Health and Human Services, said Friday on ABC‘s “Good Morning America.”

“We’re looking at 20 million Americans being vaccinated just in the next coming weeks, up to 50 million total by the end of January, and we believe we can have 100 million actual vaccinations in arm by the end of February,” Azar said.

After the FDA released Hahn and Marks’ statement Friday, President Donald Trump, who has repeatedly said that he pushed the agency to move more quickly in its authorization process of different treatments for Covid-19, said the FDA “is still a big, old, slow turtle.”

“Get the dam vaccines out NOW, Dr. Hahn @SteveFDA,” he said on Twitter, tagging the FDA commissioner. “Stop playing games and start saving lives!!!”

At the meeting of the advisory committee on Thursday, Pfizer’s head of vaccine research and development, Kathrin Jansen, made her company’s case for why the committee should recommend the FDA issue an emergency approval of the vaccine. She said the vaccine is one of society’s greatest hopes for ending the pandemic, which has killed nearly 300,000 people in the U.S. in less than a year, and return to a sense of normality.

Though Thursday’s meeting was not without debate. FDA advisors questioned Pfizer and FDA staff on a number of issues, including a lack of data on the vaccine’s safety profile in pregnant women and young children. Following the vote, a few committee members who voted against recommending authorization said they did so because they did not want people younger than 18 to be included in the emergency approval because the data on that age group was too “thin.” The advisory panel recommended the use in people age 16 and above.

Dr. Paul Offit, who voted to support the emergency approval, grilled Pfizer at the meeting over two cases of allergic reactions reported by U.K. health-care workers vaccinated against Covid-19. He pressed Pfizer and FDA staff on what they plan to do to ensure the vaccine is safe for Americans with a history of allergies.