As coronavirus variants spread, FDA drawing up guidance for adjusted vaccines, diagnostics


Amid emerging coronavirus variants, the Food and Drug Administration (FDA) is drafting guidance to help companies tweak vaccines, therapeutics and tests, should that need arise.

“We are committed to identifying efficient processes for authorized products that may need to be modified, based on information on emerging variants,” Dr. Janet Woodcock, acting commissioner of the FDA, said in a statement posted Thursday. “We do not believe there will be the need to start at square one with any of these products.”

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The recently approved vaccines appear to remain effective against strains circulating across the U.S. Moderna is forging ahead with plans to advance a booster candidate specifically against a variant first identified in South Africa, and Pfizer and BioNTech are working to develop a booster shot against concerning strains as well, Bloomberg reported. Pfizer previously touted flexibility in the mRNA vaccine’s platform to make quick changes, if deemed necessary.

Woodcock told reporters on a call Thursday that the FDA won’t require the sizeable clinical trials needed for emergency approvals to evaluate booster shots, Reuters reported. A forthcoming proposal on the evaluation process could come in a few weeks, and would likely require safety data and a review by outside experts.

Meanwhile, growing data suggests that the variant from South Africa nearly escapes convalescent plasma treatment and antibody drugs. 

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“For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities,” Woodcock said.

However, the variants don’t pose a significant threat to COVID-19 molecular tests. The FDA said it would update the public with plans as they become available amid the evolving situation.



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