New rules for COVID vaccines "unleashed"

It's all come to pass. The leaders at FDA just published the new rules for COVID vaccines in New England Journal of Medicine this morning (https://www.nejm.org/doi/full/10.1056/NEJMsb2506929). It boils down to the limits put on the recent Novavax license will also apply to the mRNA vaccines. People over 64 will be eligible for fall boosters and everyone else will have to be in at-risk categories. Manufacturers will also have to conduct additional clinical trials with placebo controls.

We’ll see how all this works out in Thursday’s FDA VRBPAC meeting.