FDA Commissioner Says Agency Not Against mRNA Vaccines

The Food and Drug Administration commissioner said on Feb. 23 that the agency is not opposed to vaccines using messenger ribonucleic acid (mRNA) technology, shortly after the agency agreed to consider an mRNA influenza vaccine from Moderna following an initial rejection of the company’s application.

“I think that would be quite a stretch, to say we’re not embracing mRNA vaccines. We’ve approved two mRNA vaccines at the beginning of my time,” Dr. Marty Makary, the FDA’s commissioner, told reporters in Washington.

The FDA approved a new mRNA-based vaccine for COVID-19 in 2025 and updated clearance for two existing mRNA shots targeting COVID-19. Regulators also expanded approval for Moderna’s mRNA vaccine against respiratory syncytial virus.

Makary was answering a question during an event at which officials announced that they would be making it easier to secure approval for drugs aimed at rare diseases. A reporter asked whether there was a contradiction between the government’s appearing to embrace therapies that edit genomes and not embracing mRNA products.

“I would love to see the data on mRNA helping patients with cancer and a number of conditions,” Makary said. “Our job is to review applications that come in the door. And if the data support the claims that want to be made, we will approve that product.”

Moderna and Merck are among the companies experimenting with mRNA treatments for cancer. Some preliminary data also indicate that mRNA vaccines could cause cancer, Dr. Wafik El-Deiry, director of the Legorreta Cancer Center at Brown University, told a federal committee in 2025. Moderna has said that is not true.

The FDA recently rejected a Moderna application for an mRNA-based flu vaccine, stating that the company used a weak comparator vaccine in a clinical trial. The FDA, several days later, on Feb. 18, said that it would review the application, after Moderna agreed to file it on a different track for older people and pledged to run a fresh trial if approval is granted.

The Department of Health and Human Services (HHS), the FDA’s parent agency, has also received criticism for scaling back investment into mRNA research. Health Secretary Robert F. Kennedy Jr. over the summer canceled about $500 million in contracts for research into mRNA vaccines and drugs.

“The data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu,” Kennedy said in a post on X at the time.

The money was shifted toward a project created by National Institutes of Health scientists that is using a different technology to try to develop universal flu and coronavirus vaccines.

“There was funding for mRNA technology at HHS,” Makary said on Feb. 23. “That funding was pivoted to other causes, and I’ll tell you why. It’s not because we don’t believe in mRNA technology. It’s because the companies that made mRNA vaccines made over $50 billion; they can fund their own research. It doesn’t have to be on the backs of American taxpayers.”

Moderna and Pfizer-BioNTech mRNA shots raked in billions of dollars for the manufacturers. The Moderna shot was developed with the help of funding from the federal government, while BioNTech received funding from the German government.

“We should be funding research that is otherwise not getting funded, that has no money for funding, such as funding for bespoke conditions and rare diseases, conditions that have been in the blind spots of modern medicine,” Makary said. “Our job as regulators is to be a referee, and we just want to see good science.”