A groundbreaking flu vaccine developed by Moderna moved significantly closer to reaching the public on Thursday after an FDA advisory committee unanimously endorsed the company’s mRNA-based shot, marking a potentially major advancement in seasonal influenza prevention.

Members of the FDA’s independent vaccine advisory panel voted 9-0 in favor of the vaccine, concluding that its benefits outweigh its risks for adults ages 50 to 64 as well as those 65 and older.

Moderna is pursuing full approval for individuals between 50 and 64 years old, while seeking accelerated approval for those 65 and above. As part of that pathway, the company will be required to conduct an additional study after the vaccine becomes available to older adults.

Despite the panel’s endorsement, the vaccine’s future remains uncertain.

The recommendation is advisory rather than binding, and the FDA must still make a final determination by Aug. 5. Complicating matters, the agency currently lacks both a permanent vaccine chief and a confirmed commissioner, leaving questions about who will ultimately sign off on the decision.

Even if the FDA grants approval, the vaccine must still receive a recommendation from the Centers for Disease Control and Prevention’s advisory committee. However, that panel is currently unable to meet after a federal judge blocked it from convening under its present membership.

Once the committee eventually issues a recommendation, the CDC director will decide whether to adopt, modify, or reject it. The CDC also lacks a permanent leader, with National Institutes of Health Director Jay Bhattacharya currently serving as acting CDC director.

Influenza claims tens of thousands of lives annually, with older adults facing the greatest risk of severe illness and death. Existing vaccines designed specifically for seniors are available, but they generally require longer production timelines and lack the adaptability offered by mRNA technology.

“Having this technology available puts us in a better position to be prepared for emerging strains or pandemic strains in the future,” said panelist Flor Munoz-Rivas, an infectious disease specialist at Texas Children’s Hospital.

Under the current system, vaccine manufacturers must select target strains many months before flu season begins. That delay allows viruses to mutate, which can reduce the effectiveness of the final vaccine.

By contrast, mRNA vaccines can be produced far more quickly and updated later in the season if necessary to better match circulating strains.

“I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” said panel member Hayley Gans, a professor of pediatrics at Stanford University Medical Center.

According to Moderna’s data, the vaccine lowered flu infections by approximately 27 percent compared with a standard-dose flu shot among adults aged 50 and older.

In a separate, smaller study involving adults 65 and above, the mRNA vaccine produced a robust immune response when compared with an existing high-dose flu vaccine already recommended for seniors.

“We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010,” Moderna CEO Stéphane Bancel said in a statement. “We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review.”

The vaccine’s journey to Thursday’s vote was far from smooth. Earlier this year, a senior FDA official initially declined to review the application.

Vinay Prasad, who previously led vaccine efforts at the agency, said the application was turned down because Moderna compared its vaccine to a standard flu shot in adults 65 and older rather than to the high-dose vaccine commonly used for that age group.

Such refusals are uncommon, and critics argued that the decision reflected increasing skepticism toward mRNA technology under Health and Human Services Secretary Robert F. Kennedy Jr.

Kennedy has repeatedly criticized mRNA vaccines, previously describing Moderna’s COVID-19 shot as “the deadliest vaccine ever made,” while HHS last year canceled nearly $500 million earmarked for mRNA vaccine research.

Moderna challenged the FDA’s refusal, and the agency unexpectedly reversed its position just one week later, allowing the application process to move forward.

{Matzav.com}