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COVID-19 Vaccine Updates

February 22, 2021

FDA Issues Additional Guidance for Medical Product Developers Addressing Virus Variants

On February 22, 2021, the U.S. Food and Drug Administration issued updated guidance to medical product developers with additional instructions on how to address virus variants. This guidance includes an update to the FDA’s October 2020 guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19.

The updates include considerations for data indicating the need for modified vaccines as well as recommendations for additional studies. The FDA stated that currently available information suggests that the FDA-authorized vaccines will remain effective in protecting against currently circulating strains of COVID-19. However, if variants emerge in the U.S. that are moderately or fully resistant to the antibody response elicited by the current generation of COVID-19 vaccines, it may be necessary to tailor the vaccines to the variants. While the FDA may recommend modifications to authorized vaccines, the FDA expects that manufacturing information will generally remain the same.

At the February 22, 2019 White House COVID-19 Response Team briefing, Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, explained that the updated guidance is intended to help manufacturers who want to know how they can modify their vaccines to address the ongoing evolution of variants. Dr. Fauci reiterated that manufacturing recommendations are expected to remain the same. Dr. Fauci also stated that immunogenicity studies will likely be used to determine the effectiveness of current vaccines against variants.

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