Moderna Pulls Application for FDA Approval of Flu-COVID Shot After FDA Calls for New Clinical Trials

Moderna is withdrawing its application for FDA approval of its mRNA-1083 combination flu and COVID-19 vaccine, the company announced today.

by Michael Nevradakis, Ph.D.

Moderna is withdrawing its application for U.S. Food and Drug Administration (FDA) approval of its mRNA-1083 combination flu and COVID-19 vaccine, the company announced today — just one day after the FDA said it would require new clinical trials to approve COVID-19 boosters for healthy people under 65.

According to Fierce Biotech, the company will resubmit its application when data from a Phase 3 trial of its mRNA-1010 flu vaccine, which is a component of the combined shot, are available later this year. The company expects to have interim data from the trial available this summer.

Markets reacted negatively to the news, with Moderna’s shares falling 1.4% in premarket trading on Wednesday, The Guardian reported.

According to Reuters, Moderna’s decision to withdraw its application at this time “is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top U.S. health job earlier this year.”

Last week, for instance, the FDA approved Novavax’s new COVID-19 vaccine, but limited its approval to groups that are considered high-risk.

Sayer Ji, co-founder of Stand for Health Freedom and founder and director of GreenMedInfo, said Moderna’s decision to withdraw its application is “telling” and “appears to reflect not only concerns over efficacy but also a growing public skepticism toward hastily developed, multi-antigen formulations that lack sufficient long-term safety data.”

Ji said:

“The withdrawal may be a preemptive move to avoid public scrutiny or regulatory resistance tied to unresolved questions in their clinical data. Combination shots, especially those involving mRNA platforms, introduce compounded risks due to the simultaneous delivery of multiple immunogenic agents.

“These risks are poorly understood and grossly under-evaluated, particularly in vulnerable populations. The immunological complexity of such a vaccine also raises questions about long-term impacts on immune regulation, potential autoimmunity and unintended synergistic effects that could compromise health rather than protect it.”

Moderna downplays decision to withdraw, claims it’s ‘business as usual’

During an earnings call earlier this month, Moderna President Stephen Hoge sought to ease investor concerns, saying “it makes good scientific sense” to wait for data from the flu vaccine trial before proceeding with the application for the company’s joint flu-COVID shot.

“We’ll just go forward with whatever feels like the most pragmatic approach and, ultimately, the one that the FDA guides us to do,” Hoge said, adding that Moderna’s recent interactions with the FDA had been “business as usual.”

Moderna previously expected it would receive FDA approval of its mRNA-1083 combination shot in November. However, earlier this month, the company pushed back the expected approval date to next year, after the FDA requested Phase 3 clinical trial data before issuing an approval, Fierce Biotech reported.

Separately, Moderna is awaiting FDA approval of its “next-generation” COVID-19 vaccine, a component of the company’s combination flu-COVID shot, by the end of the month.

According to The Guardian, “Moderna has previously said it does not expect a delay in that decision.”

Moderna shares ‘battered’ by new vaccine testing regulations

Moderna, whose shares “have been battered” by investor concerns around Kennedy’s policies, “has been banking on revenue from newer mRNA shots to make up for falling sales of its COVID vaccine and less-than-expected uptake of its respiratory syncytial virus vaccine,” or RSV vaccine, Reuters reported.

Last year, a group of shareholders sued Moderna, accusing the company of making “materially false and misleading statements” about the efficacy of its RSV shot, resulting in significant damages for investors.

On Tuesday, the FDA revealed plans to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.

These plans are part of a “radical framework” for vaccine approval announced last week by the FDA and further detailed in an editorial published this week in The New England Journal of Medicine by FDA Commissioner Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research.

Last week, The Wall Street Journal reported that the U.S. Department of Health and Human Services (HHS) plans to stop recommending COVID-19 vaccines for pregnant women, children and teens.

Last month, HHS announced that all new vaccines will have to be tested against a placebo before they can be approved, in what the department described as “a radical departure from past practices.”

“In light of the potential for new leadership and direction under a Kennedy administration, particularly at HHS, companies like Moderna may be reassessing their regulatory strategies,” Ji said. “We could be witnessing the early ripple effects of a policy shift that favors transparency, genuine informed consent and robust safety science over fast-tracked pharmaceutical approvals.”

Dr. Joseph Sansone, who is litigating to prohibit mRNA products in Florida, said more stringent action from public health agencies is needed.

“Most people you know will have a shortened lifespan due to the COVID injections. We are seeing reduced birth rates and increased infant mortality with a reduction in lifespans,” Sansone said. “The effort should be directed toward mitigating the damage from these deadly shots, not creating more.”

Ji said, “This moment offers a valuable pause — a chance for regulators, the scientific community, and the public to demand higher standards of accountability and rigor in the approval process.”

Moderna did not respond to a request for comment by press time.

Related stories in The Defender

• FDA to Limit Approvals of New COVID Vaccines to Elderly, High-Risk Groups — But Hundreds of Millions Still Eligible for the Shots

• FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

• HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports

• RFK Jr. Will Order All New Vaccines to Undergo Placebo-Controlled Testing, Washington Post Reports

• ‘Reckless Disregard for the Truth’: Shareholders Sue Moderna for Misleading Investors on RSV Shot Efficacy

• Dr. Vinay Prasad Replaces Ousted Peter Marks as Chief FDA Vaccine Regulator