Moderna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign

Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the drugmaker said it would withdraw its application seeking approval from the U.S. Food and Drug Administration for the time being, according to a report from Reuters—the latest indication that Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s vaccine skepticism has fully infected the federal government.

Moderna isn’t giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options. But the early indicators out of its trials have been positive, with recipients of the dual vaccine generating the same or greater immune response compared to those given separate vaccines. But for the time being, the company is pulling back and doesn’t anticipate approval being granted until at least 2026.

The company’s decision to pump the brakes comes just one day after the FDA announced that it will require new clinical trials to be conducted before any of the annual covid-19 boosters receive approval for healthy Americans under the age of 65. The agency will require boosters to go through a randomized, controlled trial before getting approval—a process that vaccine makers warned would likely delay the availability of the shots well beyond the point in which they would be useful to address the currently circulating strain of covid-19 that they were designed to address.

This new restriction has already had an impact. Novavax’s covid-19 vaccine shot received approval last week, more than a month later than the initial deadline for approval, but the FDA limited access to people over the age of 65 and people between the ages of 12 and 64 who have at least one underlying condition that puts them at risk of severe illness from a covid-19 infection.

The agency is also requiring existing covid-19 vaccines to carry an expanded warning label about the risk of myocarditis, or inflammation of the heart. This is a potential side effect of the vaccines, but multiple studies have found that experiencing a covid-19 infection puts young people at substantially higher risk of experiencing myocarditis than getting the vaccine.