RFK Jr. will require shift in how new vaccines are tested, HHS says

Key Changes Proposed by HHS

The Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., is considering a significant shift in how new vaccines are tested. This change could require more rigorous testing, including placebo-controlled trials, even for vaccines for well-understood diseases. This proposal has sparked significant debate and concern.

Concerns from Experts

• Ethical Concerns: Using placebos for established diseases like measles and polio is considered unethical by many experts, as it denies proven effective treatments to the control group.
• Cost and Access: The new testing requirements could be costly and time-consuming, limiting vaccine production and potentially reducing access.
• Misinformation and Exaggeration: Critics argue that HHS statements contain misinformation and misrepresent scientific understanding of vaccine safety.
• Undermining Public Trust: The shift is viewed as potentially further eroding public trust in vaccines, particularly amidst ongoing outbreaks like measles.

Focus on Coronavirus Vaccines

Much of the debate centers on the coronavirus vaccine. HHS's intention seems to be to re-examine the approval processes for updated COVID-19 vaccines, potentially requiring new clinical trials. This could lead to delays in the availability of annual updates. The FDA's actions regarding the Novavax vaccine are highlighted as an example of potential political interference in the vaccine approval process.

Potential Impacts

Experts predict that Kennedy's changes could lead to fewer vaccines being approved and slower vaccine development, ultimately reducing vaccine availability and access. The changes also raise concerns about potential interference with the established vaccine safety monitoring systems.