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FDA authorization of COVID-19 vaccines would set off a scramble

By Emily Kopp, CQ-Roll Call on

Published in News & Features

WASHINGTON — The Trump administration's pledge to start shipping COVID-19 vaccines "within 24 hours" of a green light from the Food and Drug Administration will lead to a multi-step scramble during the time between authorization and the first shots going into arms.

Any thumbs-up from the FDA would kick-start the distribution of 6.4 million vaccine doses among 64 states, territories and major cities, based on population, Gen. Gustave Perna has said. Perna co-leads Operation Warp Speed, the Trump administration's initiative on COVID-19 vaccines and treatments.

Here's what to expect over the next few weeks.

FDA REVIEW

The first step is a scientific review by the FDA.

FDA's evaluation will likely happen quickly because as part of the administration's efforts to accelerate the process, the agency is already accepting data on a rolling basis. But the applications for emergency use authorization, like any standard application, will likely be thousands of pages long, FDA Commissioner Stephen Hahn confirmed to USA Today.

 

FDA official Peter Marks, who leads the career scientists reviewing the data, has said people should expect the process to take a few weeks. On Nov. 20, Pfizer and its partner BioNTech were the first to finish submitting all of their data.

For a COVID-19 vaccine, "we'll only be thinking about issuing (an emergency use authorization) if it's demonstrated clear and compelling efficacy in a large, well-designed, phase 3 clinical trial similar to that which would be required to support an approval. And that's because it's potentially going to be administered to millions of individuals, including healthy people," Marks said on an FDA podcast last month.

FDA also provides the data to a panel of independent experts, the Vaccines and Related Biological Products Advisory Committee, which advises the agency on vaccine approvals. Although the committee's advice is non-binding, FDA follows most VRBPAC recommendations.

The VRBPAC meeting to discuss Pfizer and BioNTech's vaccine candidate — which can be watched via livestream — is scheduled for Dec. 10.

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