US FDA approves Moderna’s new lower-dose COVID-19 vaccine

The US Food and Drug Administration has approved Moderna’s new COVID-19 vaccine, mNexspike, for use in older adults and people at heightened risk of severe disease, the company announced on Saturday.

The shot, known scientifically as mRNA-1283, is Moderna’s third approved product and will be available for adults 65 and older, as well as individuals aged 12 to 64 with at least one underlying medical condition that puts them at increased risk from the coronavirus.

That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.

Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older.

“The FDA approval of our third product, mNexspike, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” said Moderna CEO Stéphane Bancel. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”

FDA clearance was based on results from a Phase 3 trial involving more than 11,000 participants aged 12 and up. The study showed that mNexspike was non-inferior to Spikevax and demonstrated a 9.3% higher relative vaccine efficacy (rVE), the drug maker said.

Among adults 65 and older, the advantage rose to 13.5%, according to a subgroup analysis.

Participants in the trial received either a 10-microgram dose of mNexspike or a 50-microgram dose of Spikevax. The new shot had a comparable safety profile, with fewer local reactions and similar systemic side effects, including fatigue, headache, and muscle pain.

Moderna plans to roll out mNexspike in the US ahead of the 2025-2026 respiratory virus season and market it alongside its approved RSV vaccine, mRESVIA.

The announcement comes amid growing uncertainty around Moderna’s federally funded bird flu program. Earlier this week, the Department of Health and Human Services (HHS) cancelled a contract supporting late-stage development of the company’s avian influenza vaccine and withdrew its right to purchase doses.

HHS said a review determined that the bird flu project “did not meet the scientific standards or safety expectations required for continued federal investment.”

The decision comes as a setback for Moderna, which has been banking on next-generation vaccines, including for bird flu and a combined COVID-flu shot, to help offset waning post-pandemic COVID vaccine revenue.

The bird flu program had received $590 million in funding from the Biden administration, on top of a $176 million award from HHS in 2024. Moderna said it would explore alternative funding and development paths for its H5N1 vaccine.

Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, has drawn criticism over his handling of federal vaccine programs. He was censured by members of Congress earlier this year after suggesting poultry farmers allow bird flu to spread unchecked to study naturally resistant chickens.