The US Food and Drug Administration has approved Moderna’s 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.
The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy’s announcement days earlier that the agency would remove the shots from its immunization schedule.
The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots.
FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots.
Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine.
The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older.
The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study.
Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump’s goal of dramatically shrinking the federal government.
This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines.
The CDC’s outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign.
The FDA approved Novavax’s COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.
Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC.
While Moderna’s shots, as well as Pfizer-BioNTech’s Comirnaty, are mRNA-based, Novavax’s vaccine is protein-based and takes longer to manufacture.
Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
