The U.S. Food and Drug Administration has approved Moderna’s new mRNA-based seasonal flu vaccine for adults 50 and older, adding a new option ahead of the upcoming flu season.
The vaccine, called mFlusiva, is the first FDA-approved mRNA vaccine for seasonal influenza. Moderna expects it to be available at select retailers in the coming weeks for the 2026-27 respiratory virus season.
Dr. Andy Berglund, director of the RNA Institute at the University at Albany, said the technology can help researchers move more quickly when developing vaccines.
“Our chemists or biologists study those RNA modifications to understand their function in the cellular system so that we understand how they work, and so we can make sure they’re safe,” Berglund said.
Traditional flu vaccines can use inactivated virus, weakened live virus or viral proteins to train the immune system. mRNA vaccines instead deliver genetic instructions that allow the body to make a flu protein, helping the immune system recognize and fight the virus.
“It allows us to more quickly produce these vaccines. So within two to three months, you’re producing those vaccines compared to the six months it takes you using the standard egg-based vaccines,” Berglund said.
The mRNA technology does not change a person’s DNA. It prompts the body to make a protein antigen, which helps trigger an immune response.
“We’re making the protein so that an antigen or is presented to your immune system so that you will respond to that flu vaccine,” Berglund said.
The FDA granted traditional approval for mFlusiva in adults ages 50 to 64. Adults 65 and older received accelerated approval, based on evidence of immune response, while Moderna completes an additional study to confirm the vaccine’s clinical benefit for that age group.
A Phase 3 trial involving more than 40,000 adults 50 and older found mFlusiva was 26.6% more effective than a licensed standard-dose flu vaccine against the study’s flu endpoint, Moderna said.
Local pharmacies, however, are still waiting for supply and insurance-coverage details.
“With this new option, we’re going to be ordering it and potentially and then, we’ll have to wait for it to come in. We’ll also have to wait for the vaccine to be approved by insurers,” said Zarina Jalal, supervising pharmacist at Lincoln Pharmacy.
Pharmacists advise patients to speak with a healthcare provider or pharmacist about which flu vaccine is appropriate for them rather than delaying vaccination while waiting for mFlusiva. People younger than 50 are not included in the current approval and still have other FDA-approved flu-shot options.