Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

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With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants-and the regulatory agency is turning to its experience with annual flu shots to do so.

In a statement late Thursday, the regulatory agency said it is actively hashing out what kind of streamlined" clinical data makers of authorized COVID-19 vaccines could submit. The agency expects to have a draft of its guidance in the next few weeks.

The announcement suggests that makers of authorized vaccines will not be required to submit reams of data from large, months-long clinical trials, as they did for their initial authorizations. Still, data on any altered vaccine-however pared down-would still have to be enough to convince FDA scientists that a next-generation shot is safe and effective against variants. Vaccine alterations may include changes to the initial vaccine design or additions of new vaccine components, the FDA said.

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