Pfizer CEO flags concerns with US FDA's vaccine leadership

By Mariam Sunny

March 2 (Reuters) - Pfizer PFE.N CEO Albert Bourla said the company "has a problem" with the U.S. Food and Drug Administration's biologics and vaccines chief, Vinay Prasad, in response to a question about the drugmaker's recent communications with the regulator.

Bourla said on Monday, at the TD Cowen healthcare conference, that Prasad was disregarding the advice of the agency's career scientists.

The regulator's initial refusal last month to review Moderna's MRNA.O mRNA-based flu vaccine and rapid reversal have heightened concerns about internal discord at the FDA and signaled a sharp shift in U.S. vaccine policy under the Trump administration.

The changes have unsettled career staff, contributed to declining vaccination rates and introduced uncertainty around vaccine approvals.

In a letter signed by Prasad, the director of the FDA's Center for Biologics Evaluation and Research, the agency first refused to review Moderna's flu vaccine, then reversed course a week later after the company amended its application.

"I think the current director is not following the recommendations of his staff...and that's a problem," Bourla said.

Despite issues with the FDA's leadership, Bourla highlighted Pfizer's "very productive professional collaborations" with career scientists at the vaccine department, and said that the company will keep investing in vaccines.

Prasad, an oncologist and outspoken critic of U.S. COVID-19 vaccines and mask mandates, was appointed to lead CBER by Commissioner Marty Makary last year. Makary and Prasad have both criticized COVID vaccines and policies.

Under their leadership, the FDA has narrowed approvals for COVID vaccines and is reviewing deaths that it says may be linked to the shots.

Prasad briefly left the agency last year after sharp criticism over its handling of Sarepta Therapeutics' SRPT.O gene therapy for Duchenne muscular dystrophy, which led to the death of two teenage boys.