Updated Covid vaccines for the fall may be in jeopardy under RFK Jr.’s new rules

The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services Secretary Robert F. Kennedy Jr.

The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services Secretary Robert F. Kennedy Jr. in how vaccines are tested, experts say.

Under the change by Kennedy, according to an HHS spokesperson, all new vaccines will need to go through placebo-controlled clinical trials — where some people get the actual shot and others get something inactive, like a saline shot — to compare the results.

Running trials that include a placebo group is already routine for most new vaccines.

The original Covid vaccines, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials. But as the virus continued to mutate and the vaccines needed to be updated to match the circulating strain, drugmakers moved to a flu vaccine-like model — using smaller studies to test how well the updated shots triggered an immune response against the variant in question.

Like the annual flu shot, the updated Covid vaccines weren’t treated as entirely new products, since they still used the same formula, with just a tweak to what strain the vaccine would be targeting. The mRNA Covid vaccines were designed so that this change would be particularly easy to make, in the event the shots needed to be quickly updated.