In a significant turnaround, the Food and Drug Administration (FDA) has agreed to review Moderna’s advanced flu vaccine for potential approval, the company confirmed this Wednesday. This comes after an initial rejection, marking a new chapter for the mRNA-based immunization.
Just last week, the FDA had dismissed Moderna’s request to review its new flu vaccine, citing concerns over the research methodology. However, following further talks, the regulatory body has now changed its position and will proceed with the review process.
Moderna strategically divided its application, seeking standard approval for individuals aged 50 to 64 and a faster, accelerated approval pathway for those 65 and above. As part of this new agreement, Moderna has also committed to conducting a supplementary study on the older age group once the vaccine is publicly available.
The pharmaceutical company revealed that the FDA has set an August deadline for its approval decision. Should it receive authorization, this innovative vaccine could be ready for older adults by the upcoming flu season later this year.
This vaccine employs groundbreaking messenger RNA (mRNA) technology, a method frequently challenged by Health Secretary Robert F. Kennedy Jr. for its alleged safety and efficacy concerns. Despite his criticisms, the mRNA platform, known for its success in Covid vaccines by prompting the body to create viral fragments for immune response, is broadly regarded as safe and effective by the scientific and public health communities.
Although initially developed during the first Trump administration, the application of mRNA technology has seen significant cutbacks over the past year, causing considerable disruption across the vaccine sector. This has led to the cancellation of hundreds of millions of dollars in research funding and projects, alongside stricter limitations from agencies under Mr. Kennedy’s control regarding Covid vaccine recommendations for various demographics.
The initial rejection letter for Moderna’s vaccine application was signed by Dr. Vinay Prasad, the FDA’s leading vaccine official, despite objections from another high-ranking vaccine scientist within the agency. Dr. Prasad’s primary concern revolved around the control vaccine utilized in Moderna’s 41,000-person study for individuals over 65, which he deemed not to be the optimal choice for comparison.
Moderna poured vast resources, hundreds of millions of dollars, into this extensive study, further bolstered by a substantial $750 million investment from Blackstone.
At a recent pharmaceutical industry event in Washington, Dr. Marty Makary, the FDA’s commissioner, briefly touched upon the previous week’s rejection, acknowledging the controversy.
During a fireside chat, he advised the moderator, “If we’re discussing last week’s events, it’s crucial to be aware of the precise details of the trial results, which are publicly accessible.”
Expanding on the broader subject of immunizations, he defended the administration’s recent significant reduction in recommended childhood vaccinations. He stated that these changes were implemented to foster greater public confidence in federal health directives, emphasizing his desire “to see more kids get vaccinated.”
During an earnings call last Friday, Moderna’s CEO, Stéphane Bancel, warned analysts that the FDA’s actions could stifle the creation of new medical breakthroughs. He asserted that “the current unpredictable regulatory climate within the U.S. FDA poses significant obstacles for companies, patients, and the entire ecosystem of innovation.”
Meanwhile, regulatory bodies in Europe, Canada, and Australia are also evaluating Moderna’s vaccine, indicating its global significance.