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FDA says Covid vaccine makers can modify shots as variants emerge

 FDA says Covid vaccine makers can modify shots as variants emerge

 The FDA may allow vaccine makers to ease up on lengthy clinical trials once more is known about how the vaccines work against new variants.

The Food and Drug Administration has laid the groundwork for drugmakers to be able to react quickly to emerging coronavirus variants and get modified products to the public without the need for extended clinical trials.

"We are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts," Dr. Janet Woodcock, acting FDA commissioner, said in a statement Monday.

Full coverage of the coronavirus outbreak

The FDA guidance issued Monday is for companies that make Covid-19 vaccines, therapeutics and diagnostic tests as they work to keep up with evolving variants of SARS-CoV-2.

Evidence so far suggests that the two Covid-19 vaccines authorized in the U.S., from Moderna and Pfizer-BioNTech, appear to offer good protection against new variants.

But the fact that the virus continues to mutate means drugmakers will need to keep up, adapting quickly if necessary. The FDA guidance suggests companies may be able to pull back on lengthy clinical trials to prove safety and effectiveness each time a new variant emerges.

This is not unlike how the flu shot changes from year to year.

"For influenza, we are so accustomed to doing this," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said on a call with reporters Monday. Because the flu shot is so well studied, human clinical studies are unnecessary each year. Manufacturers simply modify the shots based on the strains that are predicted to be in circulation.


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