FDA Panel Recommends Against Following White House Plan for Booster Doses for All

A U.S. Food and Drug Administration (FDA) committee voted unanimously Friday to recommend booster doses of Pfizer-BioNTech’s COVID-19 vaccine for those over age 65 and those at higher risk of exposure to the virus, including healthcare, frontline and essential workers, under emergency use authorization, but stopped short of recommending boosters for the general population. (Boosters have already been authorized for those with compromised immune systems.) Pfizer-BioNTech had originally requested that the FDA consider full approval of a booster dose for all people who have been vaccinated with its shot. The 18 members of the committee voted initially 16 to 2 against that move, citing the lack of strong enough data on safety and effectiveness of boosting the general population at this time. The FDA then reworded Pfizer-BioNTech’s original request to include only those at highest risk of COVID-19, which earned a unanimous vote in favor. [time-brightcove not-tgx=”true”] Although the result wasn’t what Pfizer-BioNTech expected, Kathrin Jansen, senior vice president and head of vaccine research and development at Pfizer, said in a statement that “these data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters will be a critical tool in the ongoing effort to control the spread of this virus. We thank the committee for their thoughtful review of the data and will work with the FDA following today&...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news