FDA Advisory Panel May Go Against Recommending COVID-19 Booster Shots

On Friday, Food and Drug Administration advisory panel decided not to greenlight COVID-19 booster shots for most Americans; this will cause a challenge for President Biden’s plan to provide Americans with a third dose.

The independent panel looked over a 23-page FDA briefing that referenced recent studies also recommended emergency use of a third dose for those over the age of 65 and those at high risk of severe infection, the New York Post reported.

The panel says that more data is needed before the booster shot is given the green light to those over 16.

“In particular, there is a lack of data on effectiveness and duration,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said at the meeting Friday.

“Current evidence does not appear to show a need for boosting.”
The FDA is not required to follow the advice of independent panels. The agency has not followed the guidance of one on COVID-19 thus far.

The panel did agree that the third dose should be given a go to those over 65. But not for people between the age of 16-64.

The panel referenced a New England Journal of Medicine’s July article that says that those who got their two doses of Pfizer’s vaccine are 88% protected against the new Delta variant.

The panel experts also reviewed a Pfizer study on 306 people. They found that virus-fighting antibodies jumped threefold after a booster shot was given around six to eight months following the second dose.

However, Dr. Meg Seymour of the National Center for Health Research believes that the antibody increase wasn’t significant enough to be convincing.

“The total safety sample is very small,” she said. “The data provided did not allow us to draw concrete conclusions.