Article 5BGJG FDA advisers give thumbs up to Pfizer vaccine, paving way for authorization

FDA advisers give thumbs up to Pfizer vaccine, paving way for authorization

by
Beth Mole
from Ars Technica - All content on (#5BGJG)
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Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency.

The committee-the Vaccines and Related Biological Products Advisory Committee (VRBPAC)-made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older, and distribution of the vaccine will likely begin in the coming days.

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