Vaccine advisors for the U.S. Food and Drug Administration (FDA) 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, according to a news report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.
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 December 10th meeting.
The main question before the group was whether, based on the data so far, the benefits of the vaccine outweigh the risks in people ages 16 and older. The measure passed with 17 yes votes, 4 no votes, and 1 abstention. Some who voted no were not certain about teens ages 16 and 17 being in the initial EUA.
The experts also examined how the companies would continue their ongoing trials after the EUA, which raises issues about the loss of blinded, placebo-controlled follow-up ahead of full licensure.
The panel also addressed other issues related to the rollout of the vaccine, such as post-approval safety testing, distribution, and use in pregnant and breastfeeding women. And they pressed for more information on anaphylactic reactions that were reported in two healthcare workers on Dec 8, the first day of vaccination in the United Kingdom.
