The FDA wants to make it quicker for vaccine developers to upgrade their COVID-19 shots to respond to troubling virus variants

FDA CDER Director Dr. Janet Woodcock — Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research
Reuters

The head of the FDA outlined plans to deal with troubling coronavirus variants.
Some COVID-19 vaccines and treatments might not work as well against new forms of the virus.
Regulators will allow developers to adjust their shots, similar to updates that are made to flu vaccines to deal with changing strains.
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In an attempt to stay ahead of the coronavirus pandemic, US regulators are taking a page from decades of research on influenza vaccines.

Dr. Janet Woodcock, the acting head of the US Food and Drug Administration, said Thursday evening that the agency will build off its framework for dealing with the flu in figuring out how to keep pace with a changing coronavirus. She spoke on a call with reporters, and said that more complete guidance for drugmakers would come soon.

The goal is to allow drug companies to quickly adjust their vaccines and treatments to fight new forms of the coronavirus, while ensuring that those new products are safe and effective.

For drug companies that have already developed an authorized vaccine, for example, the FDA is aiming to allow them to adjust their vaccines without repeating massive clinical trials involving tens of thousands of volunteers.

The agency's leader also emphasized that she believes current coronavirus vaccines will work against the identified variants.

"Number one, we think the currently authorized vaccines will be effective against the strains that we know about," Woodcock said. "Number two, we don't know what's going to happen. We don't know if different strains will become predominant in the US, and we don't know then what their characteristics vis-à-vis the vaccines might be. But our point is we must prepare for all eventualities."

The rise of virus variants has raised concerns among scientists. Public-health leaders recently described it as a "wake-up call." A collection of recent clinical and laboratory results suggest that current COVID-19 vaccines may not work as well against certain variants of the virus, particularly B.1.351, which was first identified in South Africa. Some antibody-based treatments don't work as well, either.

Details are not yet available on exactly what type of research vaccine developers will be required to do to prove that their upgraded shots work, such as how many additional volunteers will be needed for trials and what those studies would have to show. Woodcock said the FDA would release specifics for its proposals in the coming weeks.

Over the past 10 days, leading vaccine developers Moderna, Pfizer, Johnson & Johnson, and Novavax have all announced research related to variants. Moderna and Novavax are both working on experimental booster shots tailored to the B.1.351 variant.

Moderna and at least one other vaccine developer are working with National Institutes of Health researchers to start human testing of these variant-specific shots in March, Politico's Sarah Owermohle and David Lim reported.

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