FDA Gives Guidance on COVID-19 Variants

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The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA announced on Feb. 22, 2021 that is has issued a suite of guidance documents to address the emergence of variants of SARS-CoV-2. The guidance documents include an update to the October 2020 guidance on Emergency Use Authorization (EUA) for vaccines to prevent COVID-19, guidance on the impact of the variants on monoclonal antibody (mAb) products and other treatments, and a guidance the impact of the variants on COVID-19 tests.

The updated guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, offers recommendations to vaccine developers regarding virus variants, including developers who already received EUA for their vaccine. The agency stated, in a press release, that FDA-authorized vaccines are effective against the current strains of SARS-CoV-2, but it may be necessary to tailor vaccines should a new variant emerge in the United States that is “moderately or fully resistant to the antibody response elicited by the current generation of COVID-19 vaccines”.

For therapeutics, FDA issued new guidance that gives recommendations for developers of SARS-CoV-2-targeting mAbs including approaches to the generation of non-clinical, clinical, and chemistry, manufacturing, and controls data to support an EUA for an mAb product effective against variants. FDA also issued a revised guidance that provides recommendations regarding Phase II and Phase III clinical trials for drugs and biologics to treat or prevent COVID-19. The revised guidance was updated to include the new virus variants and authorized COVID-19 vaccines.


“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, MD, in a press release. “We know the country is eager to return to a new normal, and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm healthcare providers with the best available diagnostics, therapeutics, and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

Source: FDA