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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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