Moderna Vaccine Wins FDA Nod
The U.S. Food and Drug Administration has approved Moderna’s (NASDAQ:MRNA) next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements.
The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement.
The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season.
“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,” CEO Stephane Bancel said in the statement.
The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines.
The FDA said on May 20 it planned to require drugmakers to test their Covid booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness.
The Moderna vaccine can be stored in refrigerators, rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives.
Shares in MRNA eased eight cents to $26.48.
