The U.S. Food and Drug Administration (FDA) supports the use of mRNA technology in vaccines but will not allocate taxpayer funding for further research, according to FDA Commissioner Marty Makary. Speaking at a press event on Monday, Makary clarified that while there had been financial support for mRNA research within the Department of Health and Human Services (HHS), those funds have since been redirected.
“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 stated.
Pfizer, together with its partner BioNTech, and Moderna developed the first COVID-19 mRNA vaccines. These products generated significant revenue, with Pfizer-BioNTech earning $37.8 billion and Moderna making $18.4 billion at their peak.
Makary emphasized that FDA's endorsement of mRNA research does not require public funding: “it doesn’t have to be on the backs of American taxpayers.” He suggested federal resources should prioritize “research that is otherwise not getting funded,” specifically referencing bespoke conditions and rare diseases where new regulatory pathways are being proposed by the agency.
The framework for these personalized medicines was introduced by Makary alongside Vinay Prasad, head of the Center for Biologics Evaluation and Research, in November but faced criticism over its lack of detailed guidance.
In August 2025, HHS canceled 22 contracts involving mRNA technology previously awarded under the Biomedical Advanced Research and Development Authority (BARDA), mainly targeting upper respiratory infections. The move resulted in approximately $500 million being withdrawn from ongoing mRNA research projects.
At that time, HHS Secretary Robert F. Kennedy, Jr. explained that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.” He said funds would instead be directed toward alternative vaccine platforms perceived as safer and broader in application.
This decision has faced opposition from several experts. Bill Moss, executive director of the International Vaccine Access Center, described it as “tragic” due to the adaptability of mRNA vaccines against evolving viruses.
Others warn about broader consequences; Jonathan Kagan from Harvard Medical School wrote in an opinion piece for BioSpace that cutting funding could hinder progress toward cancer cures enabled by this technology: “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.”
Makary addressed concerns about using mRNA for cancer treatment: “I would love to see the data on mRNA helping patients with cancer,” he said during Monday's event. He stressed FDA’s responsibility to review submitted data objectively: “If the data supports the claims that want to be made, then we will approve that product.”
Recent actions have signaled caution from regulators regarding this technology; earlier this month, FDA declined to review Moderna’s flu vaccine based on an mRNA platform [https://www.biospace.com/article/moderna-s-mrna-vaccine-refusal-comes-amid-global-advanced-therapies-push/].
Roberta Duncan—former chief strategy officer at Arcturus Therapeutics—commented during a BioSpace-moderated panel at Phacilitate’s Advanced Therapies Week: “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.”
Following discussions between FDA and Moderna after this initial refusal [https://www.biospace.com/article/moderna-s-mrna-vaccine-refusal-comes-amid-global-advanced-therapies-push/], both parties reached a compromise allowing review of an amended submission package; a final decision is expected by August.
