The Food and Drug Administration has laid the foundation for drug manufacturers to be able to react quickly to emerging variants of the coronavirus and obtain modified products for the public without the need for lengthy clinical trials.
“We are using all the tools in our toolbox to combat this pandemic, including turning as the virus adapts,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement Monday.
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The FDA guidance issued Monday is for companies that make Covid-19 vaccines, therapies and diagnostic tests as they work to keep up with the evolving variants of SARS-CoV-2.
The evidence so far suggests that the two Covid-19 vaccines licensed in the US, De Moderna and Pfizer-BioNTech, appear to offer good protection against new variants.
But the fact that the virus continues to mutate means that drug manufacturers will have to keep up, adapting quickly if necessary. The FDA guidance suggests that companies can go back in lengthy clinical trials to demonstrate safety and efficacy each time a new variant emerges.
This is no different from how the flu vaccine changes from year to year.
“For influenza, we are so used to doing this,” Dr. Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, said Monday in a call with reporters. Because the flu vaccine is so well studied, human clinical studies are unnecessary each year. Manufacturers simply modify injections based on the strains predicted to be in circulation.
However, until experts have more data on Covid-19 vaccines, the FDA will continue to require drug manufacturers to study the efficacy of their vaccines against emerging strains.
“We need to understand if the new vaccine strain is capable of covering both the new strain and the old one,” Marks said. Additional security data will be needed, at least in the meantime.
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“After doing that three or four times, we’ll see everything, and if everything looks consistent, then we could move further towards the flu-like model,” Marks said.
The FDA guidance also advises developers of Covid-19 diagnostic tests and manufacturers of monoclonal antibody treatments to monitor how emerging variants could affect their effectiveness.
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