FDA to Approve Pfizer’s COVID-19 Vaccine for Emergency Use

By Tom Ozimek

The Food and Drug Administration (FDA) said Friday that it is working quickly towards finalizing its approval for emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine.

In a joint statement, FDA Commissioner Stephen M. Hahn and Director of the Center for Biologics Evaluation and Research (CBER), Peter Marks, said the agency has notified Pfizer-BioNTech “that it will rapidly work toward finalization and issuance of an emergency use authorization.”

The pair also said the FDA has notified the Centers for Disease Control and Prevention (CDC) and the Trump administration’s Operation Warp Speed initiative of the vaccine’s imminent approval for emergency use so that preparations can be made for its timely distribution.

The U.S. government has pledged to distribute 2.9 million doses of the vaccine to the public within 24 hours of FDA approval.

Health and Human Services Secretary Alex Azar told ABC’s “Good Morning America” on Friday morning that, “We could be seeing people getting vaccinated Monday, Tuesday of next week.”

“In the next couple of days, probably as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine,” Azar said.

Vials of coronavirus vaccine and a medical syringe are seen in front of a displayed Pfizer logo on Oct. 31, 2020. (Dado Ruvic/Reuters)

The FDA’s announcement and Azar’s remarks follow a Thursday vote by a 23-member panel of independent medical advisors to support the vaccine for emergency use, after discussing whether scientific evidence supports the view that the product, called BNT162b2, is effective in preventing COVID-19 in people aged 16 and older, and if the known benefits outweigh potential risks.

“We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a statement welcoming the panel’s vote.

“I would like to thank the FDA’s advisory committee for recognizing the critical role that our vaccine may play in helping to address this ongoing pandemic. Today’s positive discussion and vote reinforces the potential of our COVID-19 vaccine candidate in helping to protect people against this deadly and devastating disease,” said Ugur Sahin, CEO and Co-founder of BioNTech, in a statement.

The vaccine is purported to immunize against COVID-19, which is the symptomatic disease caused by the virus SARS-CoV-2. The likely regimen is for individuals to receive two doses, administered 21 days apart.

Ahead of the panel discussion on the vaccine’s safety and efficacy, the FDA issued a detailed analysis (pdf) that concluded the Pfizer-BioNTech vaccine “met the prescribed success criteria.”

Pfizer and BioNTech have said their vaccine has demonstrated an efficacy rate of 95 percent, with no serious safety concerns.

Regarding safety, the FDA reviewed data from some 38,000 participants aged 16 and older, and found “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA [emergency use authorization],” according to the analysis.

The study did note, however, that, “there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.”

People who took part in the study did experience a number of side effects after taking the vaccine, with the FDA noting the most common were injection site reactions (84.1 percent), fatigue (62.9 percent), headache (55.1 percent), muscle pain (38.3 percent), chills (31.9 percent), joint pain (23.6 percent), and fever (14.2 percent).

The FDA also released Pfizer and BioNTech’s own analysis of the vaccine’s effectiveness and safety (pdf), which indicated that data “did not suggest any serious safety concerns” and mirrored the FDA’s analysis on how effective their product is in preventing COVID-19 infection.

The companies were the first to seek emergency approval for a COVID-19 vaccine, with Moderna’s candidate, called mRNA-1273, scheduled for FDA review on Dec. 17.

This article was updated to include information about safety conclusions regarding pregnant women, children under 16, and those with compromised immune systems.

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