Variants Spur New FDA Guidance On COVID Vaccines, Tests, Dru
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The US Food and Drug Administration (FDA) updated its October guidance for manufacturers developing COVID-19 vaccines, diagnostics, and treatments in the wake of circulating SARS-CoV-2 variants.

~ Tailoring May Be Necessary

FDA Commissioner Janet Woodcock, MD, emphasized that "at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2." However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant, she said.

In that case, the effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient's immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states. Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.

~ Variants and Testing

The FDA's updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test.

For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.

~ Updated Guidance for Therapeutics

The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments. "The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged."

This guidance provides recommendations on efficient approaches to the generation of manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants."