Kennedy Orders Change in Vaccine Testing

Robert F. Kennedy Jr., who has for years voiced concerns about vaccine safety, is ordering a notable change to testing at his Department of Health and Human Services. "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices," an HHS spokesperson tells the Washington Post. Some in the medical field are concerned at the prospect, particularly the potential effect on COVID booster shots. However, many details remain to be fleshed out on the new policy.

• Basics: Vaccines for new diseases are typically vetted in placebo-controlled trials, meaning some people get the vaccine and others get a shot of saline or the like. "But for well-researched diseases, such as measles and polio, public health experts say it makes little sense to do that and can be unethical, because the placebo group would not receive a known effective intervention," per the Post.

• Booster delays? CNN sees one potential problem as a delay in COVID boosters: "Experts warn that requiring placebo-controlled trials before clearing new versions—which could involve enrolling participants, giving some the vaccine and some a placebo shot, and waiting some period of time to assess safety and efficacy—would delay availability of updated Covid shots by months, putting vulnerable people at risk."
• No effect on flu shots: HHS has not yet provided details on which vaccines will be affected, but it indicated that flu shots will not be among them, per the Post.
• Big picture: The move suggests Kennedy "will reach far into the details of vaccine development, an effort likely informed by his decades as one of the nation's most vocal critics of immunization oversight," per the New York Times. The HHS statement sought to pre-emptively shut down what could be a familiar line of attack: "Secretary Kennedy is not anti-vaccine—he is pro-safety, pro-transparency, and pro-accountability."
• Critic: "You are watching the gradual dissolution of the vaccine infrastructure in this country," Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, tells the Post. "The goal is to make vaccines less available and less affordable."

(More vaccines stories.)