Scientists divided on need for fourth shots after FDA authorization

Leading U.S. scientists and physicians worry that the FDA and CDC are moving too fast in approving a fourth round of Covid shots, with little public debate that gives the vaccine makers too big a role in setting the pace with which the doses are distributed across the nation.

The top U.S. public health agencies last week endorsed a fourth Covid shot for older adults without holding public meetings, drawing criticism from leading vaccine experts who believe federal health officials haven’t provided enough transparency about the reasons for the decision.

The authorization of a fourth dose for adults age 50 and older comes as the scientific community is divided over whether the data is sufficient to support another round of boosters, and whether authorizing additional shots is a sustainable public health policy, especially since protection against infection simply wears off over time. There is a debate over whether the goal of the vaccines is to prevent severe illness, which they’ve largely achieved, or infection as well — a more challenging proposition.

The Food and Drug Administration authorized a second booster shot for people age 50 and older last week, and the Centers for Disease Control and Prevention quickly backed their distribution hours later based on data from Israel, which rolled out fourth doses months ago. Dr. Peter Marks, who heads the FDA office responsible for vaccine safety and efficacy, said shortly after the decision that another round of boosters will likely be needed in the fall.

The rapid regulatory clearance of fourth shots for older adults came just weeks after Pfizer and Moderna asked the FDA to permit them. Several FDA and CDC committee members as well as other leading experts said Pfizer and Moderna are playing too large a role in setting the agenda around U.S. vaccine policy by announcing the need for fourth doses and possibly a variant-specific vaccine before the public health agencies have made any recommendations.

Moderna CEO Stephane Bancel said during a January interview with Goldman Sachs that fourth doses would be needed in the fall as the protective antibodies from the shots wane over time. Pfizer CEO Albert Bourla told CNBC in early March, before the company filed its request with the FDA, that there’s a need for a fourth dose though he said the regulators would ultimately come to their own conclusion.

“I just think it’s sort of booster mania. I think the companies are frankly acting like public health agencies,” said Dr. Paul Offit, a member of the FDA committee and one of the nation’s top vaccine experts. Offit said the CDC, which has the final say on vaccine recommendations, needs to develop a clear national strategy to reduce public confusion about what it means to be…