Moderna’s mRNA Flu Vaccine Back Under FDA Review

THURSDAY, Feb. 19, 2026 (HealthDay News) — In a sudden reversal, the U.S. Food and Drug Administration (FDA) has agreed to review Moderna’s experimental mRNA influenza vaccine. 

The move comes just one week after the agency refused to evaluate the company’s application, a decision that sent shockwaves through the biotech industry.

The initial rejection centered on the design of Moderna’s clinical trials. 

Regulators had previously argued that the company should have tested its shot against a higher-strength flu vaccine for the older adults in the trial’s control group. 

Following the rejection, Moderna modified its approach to satisfy the government’s concerns.

mRNA technology is a relatively new approach to vaccination. It gained widespread attention during the COVID-19 pandemic, when it was used to speed vaccine development.

While traditional flu vaccines inject a virus protein into the body to stimulate the immune system, mRNA vaccines supply cells with the code to make the virus protein that then stimulates the immune system.

Under the newly accepted application, Moderna is seeking two types of approval based on age. 

The company is asking for full approval for adults aged 50 to 64. For those aged 65 and older, it is seeking "accelerated approval," which allows a product to reach the market faster based on early data while more research continues.

To address the FDA's previous concerns about older people, Moderna has committed to performing a post-marketing study. This means they will continue to collect data on how well the vaccine protects seniors after it is already being used by the public.

If approved, this would be the first flu vaccine to use the same messenger RNA technology that powered Moderna’s COVID-19 shots. 

Moderna CEO Stéphane Bancel expressed optimism about the upcoming flu season. 

“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu,” Bancel said in a statement.

The FDA is expected to make its final decision on the vaccine by Aug. 5. This timeline would allow the company to distribute the shots in time for the fall respiratory virus season.

More information

The U.S. Food and Drug Administration provides an overview of vaccine development.

SOURCE: NBC News/Reuters, Feb. 18, 2026