FDA Approves New Moderna COVID Vaccine

The Food and Drug Administration approved Moderna's next-generation COVID-19 vaccine for adults 65 and older and those 12 to 64 years old with at least one underlying condition that could put them at risk of severe infection, the company said Saturday.

It was the first such approval since FDA tightened COVID vaccine standards and required drugmakers to conduct more studies before approving updated shots for healthy adults under 65.

Regulators under HHS Secretary Robert F. Kennedy Jr. are putting new restrictions on COVID vaccines, including no longer recommending them for healthy children and healthy pregnant women.

Moderna CEO Stéphane Bancel said in a news release "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone."

He said the approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19."

Moderna expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season

In a Phase 3 trial of approximately 11,400 participants, the new vaccine showed 9.3% higher relative efficacy compared to Moderna's original vaccine Spikevax in people 12 and older, and a 13.5% higher efficacy in those 65 and older.