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The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers

WASHINGTON—In an hour-long meeting in January, Food and Drug Administration career staff laid out their objections to a plan to block a new flu shot from vaccine maker Moderna. They argued that refusing to even consider the vaccine was the wrong approach to address any concerns about the product.

Vinay Prasad, the head of the FDA vaccine and biologics division, overruled them—despite the agency earlier signing off on Moderna’s approach to studying the shot. Prasad told Moderna earlier this month he wouldn’t review its flu application, arguing that its clinical trial was inadequate.

The Moderna decision is part of a pattern of regulatory U-turns and overruling of FDA staff by Prasad, a Covid-vaccine critic elevated by FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr. At least nine companies, many of them focused on rare or hard-to-treat diseases, have said Prasad’s team has surprised them in recent months with rapid shifts in its decisions, in some cases rejecting their products after previously blessing their approaches.

Prasad has amassed broad power in the agency and was directly involved in at least six of the decisions, according to people familiar with the matter. The moves can unravel efforts by companies to launch drugs and make investment much harder to come by, analysts and industry executives said.

Prasad didn’t respond to requests for comment. HHS spokesman Andrew Nixon said the agency’s Moderna review team had a “diverse set of conclusions.”

Said Kennedy adviser Calley Means: “Insisting on gold-star science in a clinical drug trial is not antivaccine.”

Prasad set off alarm bells Tuesday among lawmakers and Wall Street analysts when Moderna revealed he refused to consider its new flu shot for approval.

Agency staff in 2024 said the protocol for Moderna’s clinical trial was “acceptable,” the company said in a news release. The agency said then that for adults 65 and older, Moderna should compare its vaccine against a high-dose flu vaccine. Moderna stuck to its plan to use a standard dose of flu vaccine in the trial, but added a comparison to a high-dose shot for some people 65 and older. In August, the agency told Moderna that the comparison could become an issue in the review of the application and asked for additional analysis, which the company provided, Moderna said.

Review staff told Prasad in the January meeting that refusing to accept the application was the wrong approach, people familiar with the matter said. Some also pushed back on his criticism of how Moderna had handled the trial. Prasad, according to the people, said Moderna should only have used a high-dose flu vaccine recommended by the Centers for Disease Control and Prevention for people aged 65 and older. Some staff pointed out that the higher dose isn’t recommended for people ages 50-64, ages Moderna was also studying.

Dr. David Kaslow, a top career official who reviews vaccines, wrote a memo objecting to Prasad’s move, according to people familiar with the memo. Stat News earlier reported Kaslow’s memo and that Prasad overruled reviewers.

Prasad has told others within the FDA that he would like to issue more letters refusing to accept applications so that he doesn’t have to reject them after they have been evaluated, people familiar with the matter said. Such a practice would upend the agency’s typical approach to product reviews and could open up the FDA to more litigation, according to people close to the FDA including former officials.

Review staff pointed out the litigation risk to Prasad in the January meeting, people familiar with the matter said, but he told staff he doesn’t shy away from decisions that could result in lawsuits.

Makary said Wednesday on Fox News that some consider Moderna’s trial to have been “unethical” but that the FDA’s feedback to the company was “normal back-and-forth dialogue.”

Nixon, the HHS spokesman, said Moderna “exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists.”

Prasad, a physician and critic of the pharmaceutical industry, became well-known on social media during the pandemic, issuing frequent criticisms of Covid vaccines and pandemic health measures. He had called the FDA a “failure,” writing in a blog post that it “rubber stamps too many useless products.”

Industry leaders have said Prasad and Makary aren’t living up to their stated desire to support patients with rare diseases. “[Prasad’s] decisions in the rare disease space call into question whether the commissioner is committed to rare disease or just saying what the community wants to hear,” said Raymond James analyst Chris Meekins.

For example, Prasad told investors at a January conference, according to people familiar with the remarks, that he supports the use of “single arm” clinical trials, or experiments in which all subjects get the treatment. The results of such trials aren’t weighed against a placebo but instead something else—often how patients’ disease has historically progressed without the treatment.

But just days before, his division issued a surprise rejection to a company that had used a single-arm trial to test a treatment for a rare but life-threatening disease that can follow an organ transplant. The FDA told Pierre Fabre Pharmaceuticals that it took issue with the company’s trial, despite having no objections to it in previous meetings and communications with the company.

“We are surprised and deeply disappointed,” the company said at the time.

Prasad is facing several personnel complaints filed against him, including some that involve sexual harassment, retaliation against subordinates and verbally berating staff, people familiar with the matter said. He lives in the San Francisco area and usually commutes to the FDA’s Maryland headquarters for several days every two weeks. Taxpayers pay for his commute, which according to one estimate costs around $65,000 a year, according to an agency document reviewed by The Wall Street Journal.

In November, Prasad sent an email alleging that 10 children’s deaths were linked to Covid vaccines, but he has yet to publicly produce data to back up the claim. The email also said that staff who disagreed with his operating principles should submit their resignations.