‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

The US Food and Drug Administration was slated to transition Novavax’s COVID-19 vaccine from emergency use authorization to full licensure on April 1, when Principal Deputy Commissioner Sara Brenner intervened, asking to take a look at the application, per multiple sources familiar with the matter.

Brenner enlisted Tracy Beth Høeg, who recently joined the FDA as a special assistant to the commissioner, to help look at the application again, a source said. Brenner announced Høeg’s arrival at the agency on 2 April at Commissioner Martin Makary’s introductory all-staff meeting.

Høeg has promoted incorrect information about COVID-19 vaccines, including misinterpreted data, multiple people with vaccine expertise said.

“Having senior political staff stepping on and potentially overrule decisions made by FDA experts raises a big red flag,” said Aaron Kesselheim, director of the Program on Regulation, Therapeutics and Law at Harvard Medical School. “It is perhaps worse that none of this is being done transparently.”

The concern is increased because the interference is with a vaccine application, given President Trump’s appointment of long-time anti-vaccine activist Robert F. Kennedy Jr. to lead the Health and Human Services Department.

“This is everyone’s nightmare coming true, as far as I’m concerned, in terms of who the HHS Secretary is and the kind of people he’s put in place at NIH and FDA,” said a source who asked to remain anonymous because of their current work with the federal government.

Novavax confirmed that 1 April was their user fee goal date for a decision on the vaccine’s biologics license application (BLA).

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval,” the company said. “As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.”

An HHS official said that any claim that Brenner held up the application is “false and inaccurate.”

“Any delays to the FDA’s independent review process for the Novavax [vaccine] are a result of scientific review to ensure safety and efficacy,” the official said.

Commissioner’s Office Typically Removed From Product Decisions

The involvement of an official like Brenner in a BLA review is “unheard of,” said one former senior agency official.

Historically, the commissioner’s office and HHS have stayed out of individual product approval decisions, though their involvement is technically within the bounds of the law. The less than handful of exceptions to the practice include Kathleen Sebelius, President Barrack Obama’s Health and Human Services secretary, overruling the FDA to prevent the emergency contraception known as Plan B from being available for nonprescription use.

Political pressure also was seen as influencing the FDA’s authorization of hydroxychloroquine and convalescent plasma during the first Trump Administration’s oversight of the COVID-19 pandemic.

During the Biden Administration, two of the FDA’s top vaccine officials retired over a disagreement about COVID-19 vaccine booster strategy. Political interference in the vaccine review process appeared to play a role in their resignations.

“The history of the FDA includes a consistent precedent of final decision-making about medical products at the center level,” former FDA Commissioner Robert Califf wrote when he declined to overrule then Center for Drug Evaluation and Research Director Janet Woodcock’s decision on Sarepta Therapeutics Exondys 51 (eteplirsen). “Overruling the center director is exceedingly rare and, in my view, would be appropriate only if the center director’s decision could not be supported by the available data and information.”

Califf weighed in on the Exondy’s approval because an unusual, but formal, appeal reached his office due to disagreements between Woodcock and her staff.

In the case of the Novavax vaccine, Brenner’s involvement does not appear to be the result of any similar dispute that would appropriately make its way to the commissioner’s office.

“I will say that it is highly problematic for anyone in a political position at FDA to participate in decisions about specific products outside established dispute resolution procedures,” said Holly Fernandez Lynch, an associate professor of medical ethics and law at the University of Pennsylvania.

“The decision whether to approve a new medical product needs to be first and foremost rooted in the science,” Lynch said. “Scientific data don’t themselves lead to singular policy conclusions. Knowing a product’s risks and benefits doesn’t necessarily answer the policy question about whether those risks are acceptable in relation to the benefits, whether the evidence is sufficient, etc. And it’s appropriate for political staff to weigh in on those matters broadly, but not for specific products.”

Lynch said that “if you start to have political staff interfering in specific approval decisions, it will be very hard to know whether the medical product was approved, or rejected, because of cronyism, political vendettas, or personal beliefs/conflicts without regard to the scientific evidence.”

Former senior agency officials said it would be appropriate for the commissioner and commissioner’s office to be briefed on an upcoming approval so they know what to expect and communications could be in order. Asking staff in the center to explain their thinking on the topic also would be appropriate, they said.

But the commissioner’s office trying to change the decision would not be appropriate.

Typically vaccine approval decisions would be decided by the Director of the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research based on the review team recommendation.

The CBER Director also was involved in COVID-19 vaccine authorizations and approvals because of the high-profile nature of the decisions, a former agency official said. But typically, unless an application is high-profile or controversial, a center director would not be involved in specific approvals either.

Gottlieb: Political Tests Coming For Makary

Stakeholders are closely watching to see how newly-installed Commissioner Martin Makary handles these situations.

Scott Gottlieb, FDA commissioner during Trump’s first term, said 2 April at Politico’s 2025 Health Care Summit that he expects some very early tests “of how much [Makary] is going to establish independence in decision making, not just on policy, but on product-specific things related to vaccines or how much he’s going to be pressured by the secretary to do certain things that are clearly evidence of political decision-making in the scientific and review process.”

Gottlieb said it is typical for commissioners to guard against outside political pressure.

“We all got it, although I was fortunate,” Gottlieb said. “I mean Alex Azar in many ways was exceptional. He understood that it was important to maintain the independence of FDA and he guarded that.”

“But I’ve been around FDA for 25 years and there’s always secretaries who think they can get involved in certain decisions and we have to educate them about the importance of maintaining that firewall of the independence because it serves them well at other points,” he added.

Høeg Adds To Concerns

Adding Høeg as special assistant is raising new concerns about the commissioner’s office’s operations under Makary and Kennedy.

“She spread wild myths that got real traction,” during the height of the COVID-19 pandemic, said Jonathan Howard, who has refuted many of these claims on the blog “Science-Based Medicine,” including some Høeg made with Makary.

Howard discussed papers where she misrepresented the rate of COVID-19-vaccine associated myocarditis, while understating the harms of the virus and efficacy of the vaccine.

Howard is an associate Professor of Neurology and Psychiatry at NYU Langone Health, who wrote a book called “We Want Them Infected: How the failed quest for herd immunity led doctors to embrace the anti-vaccine movement and blinded Americans to the threat of COVID.”

He described Høeg as “a bad faith actor” who treated vaccine side effects more seriously than the possibility of death from COVID-19.

Høeg was appointed to Florida’s Public Health Integrity Committee by Joseph Ladapo, Gov. Ron DeSantis’ Surgeon General. DeSantis and Ladapo have sowed doubts about COVID-19 vaccines.

She “has been more than willing to play with data,” said Dorit Rubinstein Reiss, a professor at UC Law, San Francisco who focuses on legal issues related to vaccines.

“She is not Del Bigtree, but not science-based,” Reiss said, referring to the anti-vaccine television and film producer Del Matthew Bigtree.

Lynch said that even if Høeg is qualified, she should not be reviewing a vaccine application as a political staffer.

“Because it’s problematic for political staff to interfere in this way, I don’t think expertise or qualifications matter at all,” Lynch said. “That’s what the career staff are (were) there for.”

Cathy Kelly contributed to this report.