The US Food and Drug Administration has issued updated guidance for companies that plan to adapt their Covid-19 medical products -- including vaccines, tests and therapeutics -- to address the emergence of coronavirus variants.
Development of new coronavirus vaccines may be hitting critical mass. Here's how they workThe agency said in an announcement on Monday that it expects that"manufacturing information will remain generally the same" for authorized Covid-19 vaccines that may be updated to target variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines.
New Covid-19 variants make these activities higher risk 01:39The agency released separate guidance for Covid-19 tests and therapeutics too."The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants," Dr. Janet Woodcock, acting commissioner of the FDA, said in the announcement on Monday.
FDA officials said during Monday's call that some of the updated guidance for Covid-19 vaccines is modeled after what is already done for the development of seasonal influenza vaccines."We have experience with the fact that viruses change over time and seasonal influenza changes very frequently," Woodcock said during the call.
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