FDA Panel Backs First-Ever mRNA Flu Vaccine For Seniors

FDA Panel Backs First-Ever mRNA Flu Vaccine For Seniors

Landmark vaccine clears major hurdle

A groundbreaking mRNA flu vaccine moved a step closer to approval on Thursday after a panel of advisers to the US Food and Drug Administration (FDA) unanimously backed Moderna's new shot for older adults.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 9-0 that the benefits of Moderna's mFlusiva vaccine outweigh the risks for people aged 50 and above.

If approved, it would become the first mRNA-based flu vaccine available to the public, extending the technology used in Covid-19 vaccines into seasonal influenza protection.

Faster response to future outbreaks

Experts on the panel said the vaccine could significantly improve the ability to respond to rapidly changing flu strains and future pandemics.

Current flu vaccines must be designed months in advance, giving the virus time to mutate and sometimes reducing effectiveness.

mRNA vaccines can be produced much faster and potentially updated later in the season if a different strain emerges.

"Having this technology available puts us in a better position to be prepared for emerging strains or pandemic strains in the future," said infectious disease specialist Dr Flor Munoz-Rivas.

Stronger protection claimed

According to Moderna's data, the vaccine reduced flu cases by roughly 27 percent compared with standard flu shots among adults aged 50 and older.

In a separate study involving people over 65, the mRNA vaccine generated a stronger immune response than existing high-dose flu vaccines commonly recommended for seniors.

Moderna chief executive Stéphane Bancel welcomed the vote, saying the vaccine could provide an important new option for seasonal flu prevention while demonstrating the flexibility of the company's mRNA platform.

Political controversy surrounds approval process

The recommendation comes after months of controversy inside the FDA.

Earlier this year, agency officials initially refused to review Moderna's application, citing concerns over the design of clinical trials involving older adults.

The decision was later reversed following an appeal by the company.

Critics argued the episode reflected growing political hostility towards mRNA technology under Health Secretary Robert F. Kennedy Jr., a long-time vaccine sceptic.

Kennedy has previously described Moderna's Covid vaccine as "the deadliest vaccine ever made" and recently cancelled nearly $500 million in federal funding for mRNA vaccine research.

Final approval still uncertain

Despite Thursday's unanimous vote, the vaccine's future remains unclear.

The FDA is expected to make a final decision by August 5, but the agency currently lacks both a permanent commissioner and vaccine chief.

Even if approved, the vaccine would still require a recommendation from the Centers for Disease Control and Prevention before becoming widely available.

That process is also facing uncertainty after a federal judge blocked the CDC's vaccine advisory committee from meeting under its current membership.

For now, Moderna has cleared a major hurdle — but politics may still prove to be the biggest obstacle before the first mRNA flu vaccine reaches patients.

SOURCE