FDA’s Makary Backs mRNA Vaccines but Says Companies ‘Can Fund Their Own Research’

screenshot of Marty Makary speaking on the Megyn Kelly Show

The Megyn Kelly Show

In August last year, the Health Department cut around $500 million in mRNA research funding, with Health Secretary Robert F. Kennedy Jr. saying the agency would instead divert the money “toward safer, broader vaccine platforms.”

The FDA believes in the promise of using mRNA technology for vaccines and will back their development—but will not commit taxpayer dollars to it.

There was funding for mRNA technology at the Department of Health and Human Services, FDA Commissioner Marty Makary told reporters at a press event on Monday, but that funding was pivoted to other causes.

“That’s not because we don’t believe in mRNA technology. It’s because the companies that made mRNA vaccines made over $50 billion dollars. They can fund their own research,” Makary said.

The first mRNA vaccines for COVID-19 were developed by Pfizer and partner BioNTech and Moderna. At their peak, the respective products made $37.8 billion and $18.4 billion.

While FDA supports mRNA research, “it doesn’t have to be on the backs of American taxpayers,” Makary continued, adding that the Health Department should instead put its resources behind “research that is otherwise not getting funded.” By way of example, he pointed to “bespoke conditions and rare diseases” for which the FDA is proposing a new regulatory path, as well as diseases that have been “in the blind spot” of modern medicine.

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.

In August 2025, the HHS terminated 22 contracts involving mRNA technology, awarded under the Biomedical Advanced Research and Development Authority, largely for upper respiratory infections. All told, the department took away some $500 million from mRNA research.

In a press announcement at the time, Secretary Robert F. Kennedy, Jr. claimed that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.” HHS would instead shift that money “toward safer, broader vaccine platforms,” he added.

The move has garnered criticism from several experts. Bill Moss, executive director of the International Vaccine Access Center, at the time called the move to defund mRNA research “tragic,” noting that mRNA vaccines can be “adapted very quickly” to keep up with a virus as it mutates.

Additionally, cutting funding for mRNA research could derail the industry’s efforts to cure cance, Jonathan Kagan, professor of pediatrics at Harvard Medical School, wrote in an opinion piece for BioSpace.

“Ideological debates about mRNA-based COVID vaccines will continue as America processes the pandemic’s impact, but if we let those fears stifle scientific progress, we will miss our best chance at eradicating cancer,” he wrote.

On Monday, Makary addressed the cancer question: “I would love to see the data on mRNA helping patients with cancer,” he told reporters, insisting that the FDA’s role is to scrutinize data filed by drug sponsors. “If the data supports the claims that want to be made, then we will approve that product.”

Still, the agency’s actions have projected skepticism of mRNA. Earlier this month, the FDA declined to review Moderna’s mRNA-based flu vaccine.

“What we’re seeing in the U.S. are the policy threats that are impacting not only mRNA-enabling technologies, but all the adjacent technologies in advancement as well,” Roberta Duncan, former chief strategy officer at Arcturus Therapeutics, said during a panel discussion moderated by BioSpace at Phacilitate’s Advanced Therapies Week immediately following Moderna’s announcement.

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.

The FDA and Moderna have since arrived at a compromise, and the agency has agreed to review an amended drug package with a decision due in August.

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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