FDA Refuses to Review Moderna’s mRNA Flu Vaccine Application

The

United States Food and Drug Administration has rejected pharmaceutical and biotechnology giant Moderna’s application for its mRNA-based flu vaccine, the drugmaker said. The move is the latest sign that the FDA, under Health Secretary Robert F. Kennedy Jr., is slow-walking vaccine approvals and taking a harder line on shots that use messenger RNA technology. The vaccine made by the Cambridge-based company uses the same mRNA technology as its COVID-19 shot.

What’s the tiff all about?

Moderna accused the FDA of not identifying any safety or efficacy concerns with the vaccine and instead taking issue with the “comparator” in its clinical trial - the vaccine the company used as a benchmark to evaluate its own shot. The FDA, in turn, said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.” The standard flu shot is FDA-approved. However, Moderna, in a news release, said that the agency’s stated reason is “inconsistent” with what regulators had told the company in 2024 and 2025. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel said in the release. He referred to the FDA’s Centers for Biologics Evaluation and Research, which reviews and approves vaccines, as well as other treatments like gene therapies. NBC reported that the Department of Health and Human Services, which oversees the FDA, would not comment on regulatory communications to individual sponsors.

Also read: Aishwarya Mohanraj Admits Using Mounjaro For Weight Loss: Who Should Take GLP-1 Drugs?

The government wants a placebo trial for the vaccine

In 2025, Kennedy had ordered that all vaccines would need to go through placebo-controlled clinical trials. When vaccines are already available for a disease, it's considered unethical to give clinical trial participants a placebo, rather than compare the new vaccine to the existing one. Giving a placebo would leave people who would be otherwise protected vulnerable to infection. Last summer, Moderna withdrew its application seeking approval for its combination flu and Covid mRNA shot after the FDA needed more data.

Kennedy calls mRNA vaccines dangerous

Kennedy, as an outspoken anti-vaccine activist, has repeatedly called the mRNA vaccines, including the COVID-19 ones, “dangerous” and “the deadliest vaccine ever made”, repeatedly downplaying the benefits of vaccines. However, various studies – including the ones published in JAMA Network and the National Institutes of Health have repeatedly said that vaccines are safe and effective. An analysis published in 2023 reviewed 17 different studies that covered more than 10 million children ages 5 to 11 years who received Pfizer’s or Moderna’s COVID-19 vaccines. Vaccinated kids had a lower risk of infection and hospitalization compared to those who were not. Six months back, the Department of Health and Human Services cancelled almost $500 million in funding for mRNA vaccine research.