Francis Collins, the director of the National Institutes of Health (NIH), says that it would “surprise” him if Covid-19 booster shot releases are not expanded, despite the Food and Drug Administration’s (FDA) panel recommendation against widespread use.
The FDA’s Vaccines and Related Biological Products Advisory Committee denied an application for the vaccine boosters except for at-risk populations and people 65 and older.
Collins dismissed the decision and said it was subject to change.
“I think the big news is that they actually did approve the initiation of boosters, and, remember, they’re taking a snapshot of right now. We’re going to see what happens in coming weeks,” he said. “It would surprise me if it does not become clear over the next few weeks that administration of boosters may need to be enlarged.”
“Based upon the data that we’ve already seen both in the U.S. and in Israel, it’s clear that the waning of the effectiveness of those vaccines is a reality, and we need to respond to it.”
The Biden administration pushed for a Sept. 20 release date for the coronavirus boosters. However, the CDC acknowledged that the release was pending FDA approval, which it did not receive.
Collins said that he was unsure whether the boosters would receive a recommendation for all age groups but was confident boosters for people under 65 would be approved. There is some concern that risks may outweigh benefits for younger people.
FDA resignations
Two FDA officials are stepping down, reportedly protesting the Biden administration’s push for booster shots.
Office of Vaccines Research and Review director Marion Gruber and Deputy Director Phil Krause are poised to leave in October and November.
Along with other worldwide expert scientists, the pair published a viewpoint in The Lancet, one of the best-known and oldest peer-reviewed medical journals. The group argued that evidence that has been made available does not support recommending booster shots for all Americans.
“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics. Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”
Krause, Gruber, and the other authors of the viewpoint urged to proceed with caution while not jumping to conclusions.
The authors stated that preliminary studies might be affected by “confounding and selective reporting.” They explained that vaccine supply should be allocated to unvaccinated populations to reduce the risk of emerging variants and serious illness.
