FDA panel votes against Pfizer’s booster shot for those aged 16-64; boosters only for elderly and high-risk

A U.S. Food and Drug Administration advisory panel voted Friday against approval of a Pfizer COVID booster shot for patients aged 16-64, but it endorsed the extra shots for those who are 65 or older or run a high risk of severe disease.

The vote by the committee of experts assembled by the Food and Drug Administration was 16-2 against those 16-64.  The panel voted 18-0 in recommending the booster to the elderly and high-risk.

“We know that there may be differing opinions of the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex, and evolving,” said Dr. Peter Marks, the FDA’s leading expert on vaccines.

“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said during the meeting.
 
“It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series. This booster dose is not likely to make a big difference in the behavior of this pandemic.”
 
Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”

 


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