FDA Agrees To Review Moderna mRNA Flu Shot With Post-Marketing Study On Seniors

The FDA has reversed course on a decision not to review Moderna’s mRNA influenza vaccine after holding a Type A meeting to resolve the roadblocks. On February 10, Moderna issued a press release notifying the public that it had received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research (CBER), signed by Director Vinay Prasad.

Prasad’s letter stated “CBER does not consider the application to contain a trial ‘adequate and well-controlled ‘” and the application is therefore, on its face, inadequate for review. This is because your control arm does not reflect the best available standard of care in the United States at the time of the study. I note that this determination is consistent with FDA’s advice given to you prior to your study.”

HHS Spokesperson Andrew Nixon further clarified the decision to refuse in a statement to Fox News. “The FDA rejected Moderna’s application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy. Moderna exposed participants aged 65 and over to increased risk of severe illness by giving them a substandard level of care against the recommendation of FDA scientists.”

Industry insiders condemned the FDA’s move and said there was no clear guidance or explanation in the refusal letter. Moderna called for a Type A meeting to resolve the issues. The FDA will now review the application after Moderna proposed a different regulatory pathway. Instead of seeking a full approval for ages 50+, the manufacturer is seeking a full approval for ages 50-64 and an accelerated approval for ages 65+ with a post-marketing requirement for conducting an additional study on seniors over 65 years old.

“The product that you’re describing is a novel, new mRNA-based influenza vaccine,” Dr. Makary explained following the refusal. “The guidance from the FDA was pretty clear. They recommended the control group use the standard of care, not the substandard of care in people over age 65. There have been concerns by physicians that people over age 65 were needlessly exposed to a higher risk of influenza complications because they were given substandard care in the control group against the FDA guidance.”

Politico reported earlier this week that FDA Administrator Marty Makary was called to the White House for a meeting with President Trump days after Moderna disclosed the FDA’s refusal decision. Anonymous sources reportedly told Politico that President Trump was frustrated, and the Type A meeting and subsequent reversal decision were a result of pressure from the White House. ACIP member Dr. Robert Malone shared the article and said, “Politico explains what is going on with mRNA products.”

HHS Rapid Response said Politico’s framing was wrong and said “The sponsor returned to the FDA with additional information and pending approval is committed to a study of older adults using a proper control group.”

MAHA advocates are upset with the FDA’s reversal, as the safety of mRNA vaccines has been frequently called into question in the years following the mRNA COVID-19 vaccine rollout. In August, Secretary Kennedy announced the cancellation of $500 million in mRNA-based vaccine development projects through the Biomedical Advanced Research and Development Authority (BARDA).

“The data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu,” Kennedy explained in August. “We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”

While the HHS Secretary acknowledged mRNA vaccines are not the safest platform for federal government research projects, the platform has not been outlawed or banned for private companies to pursue. The FDA has agreed to review Moderna’s mRNA influenza vaccine with a goal date of August 5, but there is no guarantee or agreement that the vaccine will be approved following review of the clinical data provided by Moderna.

Lawyer Richard Hughes IV, former vice president of public policy at Moderna, wrote an op-ed for Stat News saying the FDA used the trial design as a pretext for its refusal letter as part of Secretary Kennedy’s “broader campaign to undermine vaccine confidence and weaken longstanding vaccine recommendations.”

Other outlets and industry insiders have suggested that the FDA’s initial refusal, along with changing policy initiatives in the federal health agencies, will disincentivize manufacturers from innovating and creating new vaccine products for the marketplace. Secretary Kennedy and Administrator Makary have stated they are committed to restoring the FDA’s approval process to the “gold standard.”

The HighWire has reported on many health concerns associated with the mRNA COVID-19 vaccines, including fertility, miscarriages, and potential integration of DNA contaminants. Jefferey Jaxen reported about a Moderna RSV trial in which five babies in the vaccine group out of 40 had severe lower RSV respiratory tract infections that required hospitalization. One of the babies needed mechanical ventilation. Only one baby had the same infection in the control group.