• RFK Jr. mandates placebo testing for all new vaccines, a significant policy change.
• Experts warn this could delay vaccine availability and raise ethical concerns.
• COVID-19 and flu vaccine updates may be subject to the new testing requirements.

Health and Human Services Secretary Robert F. Kennedy Jr. is changing how vaccines are tested, requiring that all new vaccines undergo safety testing in placebo-controlled trials. This policy marks a "radical departure from past practices," according to an HHS spokesperson. The requirement means some individuals will receive the vaccine while others will get a placebo, such as saline, to assess the vaccine's efficacy. Notably, this approach raises the question of how it will apply to vaccines for well-established diseases like polio and measles, which have well-researched safety profiles, according to The Hill and BBC.

While the administration claims that the new rule seeks transparency, many experts find it concerning. They argue that requiring placebo trials for slight modifications to existing vaccines could inhibit vaccine access and pose ethical dilemmas. For instance, HHS has not specified which vaccines will be categorized as "new," but updates to COVID-19 vaccines may fall under this mandate. Peter Lurie, a former FDA official, pointed out that the approach could limit the availability of vital vaccines, particularly in emergency situations, as stated in the reports from HuffPost and ABC News.

Health officials have expressed concern that this policy could delay vaccine rollouts significantly, particularly for COVID-19 vaccines that undergo annual updates to align with circulating strains. The HHS spokesperson indicated that while the yearly flu vaccine may be exempt from this policy due to its long-standing history of safety, other updates might require additional trials. This ambiguity raises further questions about the intended application of the new rules as cited by both The Hill and ABC News.

Kennedy has a history of promoting anti-vaccine sentiments and has raised doubts about the established safety of vaccines. He suggested that current vaccine trials do not provide adequate transparency, arguing for the necessity of placebo-controlled studies even for vaccines with proven efficacy. This perspective has emerged amidst rising measles cases across the U.S., intensifying debates over vaccine safety and public health measures, as noted by BBC and HuffPost.