Overview

• HHS Secretary Robert F. Kennedy Jr. has officially implemented a policy requiring all new vaccines to undergo placebo-controlled trials before approval.
• While placebo-controlled trials are a standard for new vaccines, experts argue that applying this requirement to updates of existing vaccines could delay critical seasonal shots.
• HHS clarified that vaccine trials conducted years ago are no longer sufficient, emphasizing the need for fresh clinical data to ensure safety and efficacy.
• Experts, including Dr. Peter Hotez and Dr. Paul Offit, warn that the policy could discourage pharmaceutical companies from developing vaccines and slow public health responses to emerging threats.
• Public health advocates have formed the Vaccine Integrity Project to address concerns about vaccine access and counter potential misinformation stemming from the new mandate.