FDA grants limited approval to new Covid vaccine from Moderna

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical condition that increases their risk for severe Covid.

The approval, which is limited to individuals who have previously received a Covid vaccine, was granted by the FDA on Friday.

Moderna said in a Saturday press release that the new vaccine should be available in the U.S. in time for the 2025-26 respiratory virus season, which starts in the fall. Moderna is also updating its original vaccine to target the LP.8.1 variant this fall. The company submitted an application in May for the FDA to approve the updated formula.

The newly approved vaccine, mNEXSPIKE, contains one-fifth of of Moderna’s original Covid vaccine dose, Spikevax. It is intended as an alternative for individuals who prefer a lower-dose option, not as a replacement for existing Covid vaccines.

But young, healthy adults won’t be eligible to receive it, despite their inclusion in Moderna’s clinical trial.

The FDA imposed similar limitations on Novavax’s Covid vaccine when it approved the shot last month. But Friday marks the first time the FDA has greenlit a vaccine since the Trump administration’s call for tighter restrictions on vaccine eligibility and approvals.

The FDA said last month that it would limit its approval of updated Covid shots moving forward to older adults and younger people with underlying medical conditions. Health and Human Services Secretary Robert F. Kennedy Jr. also announced last week that the Centers for Disease Control and Prevention would no longer recommend Covid vaccines for healthy children and pregnant women. The CDC website appears to soften that recommendation, suggesting that parents can speak with a doctor about vaccinating children 6 months and older.

The Trump administration has also said new Covid vaccines must undergo clinical trials with an inert placebo — meaning some participants would receive the new vaccine while others would receive an inactive substance like saline, to compare results.

Many new vaccines are tested against older, approved versions, a method considered to be more ethical since using an inert placebo would mean withholding the benefit of a vaccine from study participants.

Moderna’s new vaccine was tested this way, using what’s known as an “active comparator.” In a trial of around 11,400 participants ages 12 and up, the new vaccine generated higher antibody levels than the company’s original Covid shot, according to Moderna.

The company also said the new vaccine had fewer local reactions, which typically include redness or swelling at the injection site. Systemic reactions, which may include fever, headaches or chills, were comparable between the shots.

The main side effects of mNEXSPIKE were injection site pain, fatigue, headache and muscle pain, Moderna said in its press release.