FDA authorization of Pfizer vaccine will come ‘days to a week’ after panel meeting

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Food and Drug Administration (FDA) regulators may not make a decision about authorizing Pfizer’s COVID-19 vaccine until next week, according to an agency official.

Peter Marks, the director of the FDA division overseeing vaccines, said Wednesday that a decision would come “days to a week” after an agency advisory panel meeting Thursday.

Members of the agency’s Vaccines and Related Biological Products Advisory Committee will meet Dec. 10 to publicly evaluate the evidence from Pfizer and its partner BioNTech. 

The independent panel of experts is likely to recommend the full agency grant emergency authorization to the Pfizer-BioNTech COVID-19 vaccine. 

Agency reviewers on Tuesday endorsed the safety and effectiveness of the vaccine, finding it was 95 percent effective at preventing infection after two doses. 

The FDA has been under pressure from President Trump and others in the administration to move much more quickly in granting emergency authorization.

Canada on Wednesday became the third country to approve the Pfizer vaccine, following the United Kingdom and Bahrain.

FDA Commissioner Stephen Hahn was summoned twice to speak in person with top administration officials to explain the agency’s timeline regarding the Pfizer and Moderna vaccines.

During a summit at the White House on Tuesday, Trump unprompted said he is “pushing them hard.”  

Throughout the process, Hahn has tried to temper expectations even as COVID-19 cases spike nationwide. More than 2,000 people are dying every day, and the numbers are expected to increase in the coming weeks.

A vaccine authorization normally takes months after an application has been submitted, not weeks.

Pfizer filed its application with the agency on Nov. 20.

Once an authorization is issued, the administration’s Operation Warp Speed will quickly begin mass distribution. Supplies such as needles, syringes and alcohol wipes are set to begin shipping Wednesday, officials said, but the vaccine itself will not ship until authorization is granted.

The administration’s goal is to vaccinate 20 million people by the end of the year.

Tags Coronavirus Donald Trump FDA approval Food and Drug Administration Stephen Hahn Vaccine

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