1 of 2 | The U.S. Food and Drug Administration headquarters is shown in Silver Spring, Md. The FDA has approved a new flu vaccine for adults over 50 that uses mRNA technology. File photo by Jim Lo Scalzo/EPA-EFE
Aug. 6 (UPI) — The U.S. Food and Drug Administration has approved a new mRNA-based seasonal flu vaccine for people 50 and older, Moderna said.
The vaccine, called mFLUSIVA, is the first in the United States to use mRNA technology against the flu and be approved by the FDA.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors, Stephane Bancel, Moderna CEO, said in a statement Wednesday. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.”
The new vaccine should be available this fall. A Moderna study during the 2024-25 flu season found it to be about 27% more effective than the standard flu vaccine. That study enrolled more than 40,000 people 50 and older.
“We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible,” Bancel said.
A year ago, U.S. Health Secretary Robert F. Kennedy Jr., a vocal vaccine skeptic, canceled 22 federal mRNA vaccine development projects worth $500 million, claiming the “technology poses more risks than benefits for these respiratory viruses.”
The FDA said earlier this year that it would not review Moderna’s new vaccine but reversed course not long after that.
Moderna and Pfizer used mRNA technology in their COVID-19 vaccines, whose rapid development during the pandemic was once lauded by President Donald Trump and his administration. Kennedy and other officials during Trump’s second term have largely reversed on this support.
The Advisory Committee on Immunization Practices of the U.S.Centers for Disease Control and Prevention usually meets after the FDA approves a new vaccine and decides whether to recommend it.
However, Kennedy replaced all the committee’s members with vaccine skeptics and a federal judge ruled in March that he did not follow federal legal procedures when doing so. It hasn’t met since. The judge also blocked Kennedy’s changes to recommended immunization schedules.
Senate Majority Leader John Thune, R-S.D., speaks during a press conference after weekly Senate caucus luncheons at the U.S. Capitol on Tuesday. With the August recess approaching, Senate Republicans are looking to confirm Acting Attorney General Todd Blanche as Attorney General and pass a budget bill to prevent a shutdown before the midterms. Photo by Bonnie Cash/UPI | License Photo
