HHS Requires Placebo Trials for All New Vaccines

The U.S. Department of Health and Human Services (HHS) announced a new policy requiring all new vaccines to undergo placebo-controlled trials before receiving approval, representing a significant shift from previous vaccine testing practices. This policy aims to increase transparency and public trust but has raised concerns among medical experts about potential delays in the rollout of updated vaccines, particularly for rapidly evolving viruses like COVID-19. While vaccines for new pathogens are typically tested this way, experts caution that applying placebo trials to vaccines for well-studied diseases such as measles and polio could be unethical, as it would withhold known effective interventions from some participants. The HHS clarified that the change would not apply to the annually updated flu vaccine, which has a long-established safety record. Some experts warn that the new requirement could slow access to important immunizations, especially for vulnerable populations. HHS stated that the policy is intended to promote safety, transparency, and accountability in vaccine approval.