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Why Requiring Placebo-Controlled Trials For New Vaccines Could Harm Americans

  • The Department of Health and Human Services in the United States has introduced a new mandate requiring placebo-controlled clinical trials for all newly developed vaccines, impacting updates such as Novavax's COVID-19 vaccine.
  • This policy stems partly from concerns about vaccine safety transparency, though public health experts note that many childhood vaccines were already tested with placebos.
  • Experts warn that placebo trials for modest vaccine updates may delay availability and are considered unethical when withholding established vaccines from control groups.
  • Dr. Lurie said requiring placebo tests for minor vaccine upgrades could be costly and cause manufacturers to abandon improved vaccines, risking health consequences for millions.
  • The new trial mandate may slow critical vaccine rollout during peak seasons and increase public skepticism due to mixed messages, potentially harming overall vaccination rates.
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BBC News broke the news in United Kingdom on Thursday, May 1, 2025.
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