An advisory panel meets Wednesday to determine whether the Pfizer vaccine should receive emergency approval in the United States.
The panel will review the results of both the FDA’s and Pfizer’s findings on the efficacy and safety of the vaccine.
“Based on both of these presentations the panel votes on whether or not approval should be granted,” said Dr. Lucio Meile, Assistant Dean for Transitional Research at LSU Health New Orleans School of Medicine. Meile is also a former employee at the Food and Drug Administration.
Once the panel makes its recommendation Meile said the ball will be in the FDA’s court.
“The FDA doesn’t have to follow the panel’s recommendations by law but it usually does,” said Meile.
The FDA has already posted its review of the vaccine publicly. Meile said that review “looks extremely good”, but the report also warns some suffer heavy, temporary side effects after their second shot.
Meile said the FDA emergency approval of the vaccine is expected to happen very shortly after the panel submits its recommendation.
“This can be accomplished in a manner of a few days in case of an emergency authorization because everyone has already seen all of the data and there won’t be any surprises at the meeting,” said Meile.
A CDC committee will meet Friday and Sunday to finalize plans on who to vaccinate first. If both committees wrap their work up by the end of the weekend shots could start being put in arms early next week.
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