Vaccine advisors for the Food and Drug Administration (FDA) today recommended emergency use authorization [EUA] for Pfizer-BioNTech’s COVID-19 vaccine, clearing one of the last hurdles before immunization is set to begin within days for the first groups to receive it—healthcare workers and nursing home residents. The FDA typically follows the recommendations of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC), and FDA Commissioner Stephen Hahn, MD, has said this week that the FDA will make its approval decision shortly after the meeting. As FDA advisors took up the issue today, researchers published the peer-reviewed phase 2/3 findings in the New England Journal of Medicine, fleshing out more details about safety and efficacy. Earlier this week, the VRBPAC signaled its support for the vaccine in extensive background materials released ahead of the meeting.

 

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