- The FDA has approved Moderna’s mFLUSIVA vaccine for adults aged 50 and older.
- Approval without further safety studies is based on physical data from at least 41,000 participants aged 50–64; the material indicates that the vaccine has an effectiveness against confirmed influenza virus infection of 26.6% (or about 27%) compared with the previously used standard flu vaccines.
- In the United States, the FDA approved Moderna’s vaccine for the 50–64 age group, while the ACIP voting committee did not.
In the US, the Food and Drug Administration (FDA) has approved Moderna’s vaccine for the 50-and-older age group for the coming flu season. The manufacturer is Moderna, and the vaccine is called mFLUSIVA.
According to Moderna, mFLUSIVA is approved for use in all adults aged 50 and older. It also states that the FDA also approved the vaccine for adults aged 65 and older based on the results of an ongoing study.
The approval was based on physical data from at least 41,000 participants aged 50–64. The material specifies that the vaccine produced a 26.6% (or about 27%) reduction in confirmed influenza virus infections compared with the standard flu vaccines in use during the 2024–2025 season.
The FDA’s approval for the 50–64 age group came despite the fact that, according to the manufacturer, the vaccine’s effectiveness against confirmed influenza virus infections was lower than that of the previous standard flu vaccine, while the ACIP committee voted against it for the 65-and-older group.
Moderna said it expects the mFLUSIVA vaccine to address gaps in protection for the 2026–2027 flu season. The materials also note that the company expects the vaccine to have a broader application.
In its materials, the company describes the vaccine’s effectiveness in terms of the reduction in the likelihood of developing influenza (fever, cough, sore throat, muscle aches, headache, and other symptoms), as well as the reduction in the risk of complications.
Moderna’s general director Stéphane Bancel said the company’s new mRNA vaccine could help protect older Americans. The materials note that Flu is linked to severity of illness, while mFLUSIVA aims to deliver new options for Americans.
Also, the materials say that the FDA’s decision was based on data submitted by Moderna regarding the vaccine’s effectiveness in the 50–64 age group, while the reason for the ACIP committee’s critical vote was that it wanted more data on the vaccine’s effectiveness for the older group.
Meanwhile, the FDA’s approval of the vaccine for the 50–64 age group in the US is subject to the Advisory Committee on Immunization Practices (ACIP) at the CDC, which according to the materials did not support it. In a related story, NBC News noted that the director of Boston Children’s Hospital’s Precision Vaccines Program, Dr. Levi, said the vaccine could be approved for use in certain cases, but that it was not yet clear whether the vaccine would be effective for all people.