17th September, 2021
A U.S. Food and Drug Administration (FDA) advisory panel rejected approval of Pfizer/BioNTech’s third dose for the U.S.
The vote comes after a heated debate in recent weeks over the need for booster or additional shots, which both mRNA companies — Pfizer and Moderna (MRNA) — have advocated for.
Dr. Peter Marks, the FDA’s leading expert on vaccines, touched on the controversy in his introductory remarks.
“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,” Marks said.
He added the meeting focused on almost real-time analyses compared to what is happening in the world, and the goal remains slowing the spread of COVID-19, which is killing almost 2,000 Americans daily.
The question the advisory panel was given to consider only used the U.S. data, a small dataset, despite the presentations including data from the U.K. and Israel.
Marks instructed the panel to consider all the data, noting, “This is not a legal proceeding, this is a science proceeding, so you can take all the data into account.”
The meeting precedes a September 20 start date for additional doses, announced last month by the White House COVID-19 Response Team, despite U.S. Centers for Disease Control and Prevention (CDC) data showing some Americans are already receiving third doses.
Last month, the CDC recommended additional doses for immunocompromised people.
A CDC advisory panel will meet next week to discuss recommendations for who should receive a booster dose.
At a Response Team briefing Friday, U.S. Surgeon General, Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and state officials to help roll out additional doses.