FDA Shuts Out Its Own Experts in Authorizing Another Vaccine Booster

Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics

By Marty Makary. Excerpts:

"At the crux of the broad opposition to second boosters is the recognition of B- and T-cells, which public-health officials have long ignored. They talk only about antibody levels, which tend to decline in the months after vaccination. B- and T-cells, activated by the primary vaccine series or an infection (and augmented by a single booster in older patients), are highly and durably effective at preventing serious illness from Covid. An additional vaccine dose induces a fleeting high in antibody levels, offering only mild and short-lived protection against infection.

Two top FDA officials quit the agency in September complaining of undue pressure to authorize boosters. Marion Gruber, former director of the Office of Vaccine Research and Review, and her deputy, Philip Krause, later wrote about the lack of data to support a broad booster authorization.

Hours after the FDA authorized the fourth dose, the Centers for Disease Control and Prevention gave its formal approval to the move—also without convening its external vaccine experts."

"While the FDA has approved fourth doses quickly and with little supporting data, it’s also been sitting for months on ample data supporting two new Covid vaccines. Novavax and Covaxin use traditional vaccine technology, in contrast with the mRNA shots from Pfizer and Moderna. Covaxin, developed by Bharat Biotech and Ocugen, could yield broader protection against variants, and both shots could overcome some Americans’ hesitancy about a novel technology. But the FDA hasn’t acted on Novavax’s Jan. 31 application for emergency use, and it rejected Covaxin twice, once for adults and once for children. Both have been approved by the World Health Organization and other countries. “We don’t need another vaccine,” Anthony Fauci, President Biden’s chief medical adviser, told India’s News Nation in December. “We have enough vaccines.”"