The FDA just approved a new Covid vaccine

The Food and Drug Administration (FDA) just green-lit a new Covid vaccine from Moderna, the company said in a press release Saturday. Now the vaccine will bump up against an administration that is loath to recommend it.

The vaccine, called mNEXSPIKE, was approved for adults 65 and older, and people between 12 and 64 years old with “one or more underlying risk factor” defined by the Centers for Disease Control and Prevention (CDC), including conditions like cancer, asthma, and HIV. In a clinical trial of more than 11,000 participants, the vaccine showed higher efficacy than Moderna’s earlier vaccine.

According to Moderna CEO Stéphane Bancel, the shot offers an “important new tool to help protect people at high risk of severe disease.” Covid, as Bancel noted in the press release, “remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”

Moderna’s announcement comes just days after Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a video posted to X that the CDC would drop Covid vaccine recommendations for healthy children and pregnant women, a decision made outside the agency’s formal expert review process. Previously, everyone 6 months and older was advised to get vaccinated.

“I couldn’t be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,” Kennedy said on X. “We’re now one step closer to realizing President Trump’s promise to make America healthy again.”

Many experts in the medical community expressed concern about the guidance and how it was delivered. “We were not consulted about this,” Dr. Sean O’Leary, chair of the American Academy of Pediatrics committee on infectious diseases, told ABC News. “My biggest concern is about the process. This really ignores a long-established, evidence-based process that has been used to make vaccine recommendations in the US.”

While children are at less risk from Covid generally, many, especially young children, can develop severe illness. Pregnant people, too, are at heightened risk of illness and complications.

On Thursday, the CDC updated its guidance, with a clarification to Kennedy’s plans: Healthy children can still get the vaccine, the CDC said, through “shared clinical decision-making” between their parent and doctor. In other words, rather than advising against the vaccine, the CDC recommended parents speak to their doctors about it. (The American Academy of Family Physicians and the American Academy of Pediatrics recommend children get the vaccine.) The agency’s Covid vaccine guidance for pregnant adults reads, “No Guidance/Not Applicable.”

All this is likely to thwart the impact of Moderna’s shot. Experts worry the changes in recommendations will mean insurers will be less willing to cover Covid vaccines or doctors less likely to stock them, making them harder to access. As former Moderna executive and George Washington University health care law lecturer Richard Hughes told NPR earlier this week, “Expect variability in coverage, prior authorization and out-of-pocket [costs], all of which will discourage uptake.”