FDA SNUBS mRNA Flu Vaccine! What This Shocking Decision Means for Your Health!

(TNND) — In a surprising decision that may have significant implications for vaccine research, the U.S. Food and Drug Administration (FDA) has chosen not to review Moderna's application for an mRNA-based flu vaccine. This move arrives as the FDA's stance on mRNA technology, pivotal in combatting the COVID-19 pandemic, faces scrutiny and raises concerns among public health experts.

Moderna announced its intention to meet with the FDA following the issuance of a “refusal-to-file” letter, which indicates the agency will not assess the company’s advanced-stage clinical trials for its flu vaccine. A review of these trials would have been the necessary next step in Moderna's quest for licensed approval.

Both Moderna and Pfizer-BioNTech have successfully produced mRNA-based vaccines for COVID-19; however, as of now, there is no licensed mRNA flu vaccine available in the market. Dr. Seth Berkley, a senior advisor at the Brown University Pandemic Center, emphasized that the FDA's decision is quite unusual. Prior to launching its Phase 3 study, Moderna had received approval from the FDA to proceed, according to the company.

Study results published by Moderna indicate that the mRNA flu vaccine demonstrated higher efficacy levels than traditional flu vaccines and exhibited a favorable safety profile. Nonetheless, Dr. Berkley pointed out that the FDA could have requested additional information or proof of the vaccine's value before initiating a review of the completed trials. “Simply accepting the application for review wouldn’t guarantee ultimate approval,” he noted.

Dr. Berkley characterized the FDA's outright refusal as a “bait and switch,” expressing concern that it might further inhibit vaccine research, particularly in the mRNA sector. He warned that companies may hesitate to invest tens of millions of dollars into vaccine development if they anticipate facing obstacles during the FDA's review process. “It's ideology, not science that's doing this,” he asserted.

The situation has been exacerbated by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has already withdrawn approximately $500 million in government funding originally allocated for mRNA vaccine research. The government also discontinued funding for a Moderna mRNA vaccine designed to combat avian influenza.

Kennedy has previously expressed skepticism about mRNA vaccines, claiming that the risks outweigh the benefits. “To replace the troubled mRNA programs, we’re prioritizing the development of safer, broader vaccine strategies, like whole-virus vaccines,” he stated in a video last summer, emphasizing a pivot towards more robust solutions in the face of emerging variants.

While Moderna maintains that the FDA did not identify any safety or efficacy issues with its trial vaccine, concerns were raised regarding the standard flu vaccine selected as a comparison for the study. HHS spokesman Andrew Nixon explained that the FDA rejected Moderna’s application for filing because the company did not adhere to explicit FDA guidance from 2024, which called for the product to be tested against a CDC-recommended flu vaccine to assess its safety and efficacy adequately. According to Nixon, this oversight exposed older study participants to heightened risks by utilizing a “substandard of care” that deviated from FDA recommendations.

In response to this setback, Stéphane Bancel, CEO of Moderna, criticized the FDA's decision as detrimental to America’s innovation efforts in medicine. He expressed disappointment that the FDA would refuse to review a submission for a flu vaccine that had been planned in accordance with prior discussions and agreements with the agency. “We look forward to engaging with the FDA to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” he stated.

Dr. Berkley explained that the mRNA flu vaccine holds potential advantages in terms of responsiveness to dominant virus strains, thanks to the rapid development pace afforded by mRNA technology. This was notably demonstrated during the pandemic, where a COVID-19 vaccine was developed in roughly 11 months, a stark contrast to the previous fastest vaccine development timeline of four years.

Despite concerns regarding the FDA's complaints about Moderna's trials, Berkley highlighted that the company did provide results from a separate trial that compared the mRNA flu vaccine against a high-dose flu shot. The Phase 3 trials reportedly included approximately 44,000 participants, suggesting sufficient data to demonstrate the vaccine's safety and efficacy. One trial focused on adults aged 65 and older, utilizing a high-dose vaccine as a control, while another trial involved individuals aged 50 and older with a standard-dose comparator.

The FDA's refusal to review Moderna's application not only raises questions about the future of mRNA vaccines but also signals potential challenges ahead for vaccine developers. As the landscape of vaccine research evolves, the implications of this decision could resonate far beyond flu prevention, influencing public health strategies for years to come.