An FDA advisory panel has voted to keep the current Covid-19 vaccine formula for the upcoming fall season. The vote comes as new FDA rules could limit who gets the updated shots.
The panel meets regularly to recommend vaccine updates. This time, however, new FDA rules complicated the decision. These rules say that vaccine makers must run new clinical trials for any updated Covid shots meant for healthy children and adults under 65. These trials would compare the real vaccine to a placebo, like a saline shot.
People at higher risk — including adults over 65 and those with medical conditions — are exempt from this requirement. They can still get the updated vaccine without delay.
The panel debated whether to pick a new strain that might work better, or stick with the current formula, which is easier to distribute. In the end, they voted to keep targeting JN.1 and its related variants. This is the same target used by Moderna, Pfizer, and Novavax.
The FDA usually follows the panel’s advice, but it doesn’t have to.
Some experts still had concerns. They worried that changing the strain could cause delays or limit who gets vaccinated. Others said the new rules weren’t clearly explained.
Dr. Vinay Prasad, the FDA’s new vaccine director, said the U.S. wants to align with Europe. Countries there focus on vaccinating older adults and people with health risks.
FDA officials said they are still working with drugmakers to figure out how the rollout will happen this fall. They promised not to delay vaccine access but asked for more time to finalize the details.
