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The FDA is developing guidance for manufacturers of diagnostics, therapeutics, and vaccines to aid their response to emerging severe acute respiratory syndrome coronavirus 2 variants, Acting Commissioner Janet Woodcock, MD, said in a statement.
Woodcock said FDA officials don’t believe they’ll have to “start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines. We do not want to create obstacles to getting these tools to the frontlines.”
The approaches include accelerating the evaluation of new monoclonal antibodies that may be effective against variants. The FDA acknowledged that some authorized monoclonal antibodies and others still under development are less effective against certain variants.
The FDA will also work with test developers to ensure that their products can accurately detect variants. Despite a low risk of known variants affecting molecular test accuracy, the agency may have companies expand monitoring for variants that affect test performance or use test designs that minimize variants’ effects. In addition, transparent labeling could help to inform users about a test’s detection capabilities.
FDA officials are also trying to determine the types of data that would be needed to support changes in existing vaccines or the addition of new vaccine components. Although authorized vaccines appear to be effective against circulating variants, the FDA said it is considering how manufacturers could streamline data reporting to demonstrate their products’ effectiveness against variants.
In addition, Woodcock said the FDA is planning how to rapidly respond to any product and supply chain disruptions, “no matter what path the pandemic takes in the next months.”
Jaklevic MC. Helping Manufacturers Navigate Novel Coronavirus Variants. JAMA. 2021;325(11):1032. doi:10.1001/jama.2021.3006
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