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As recently as May 1, 2025, the Secretary of HHS, Robert F. Kennedy Jr., instituted a requirement that all new vaccines are to be tested against an inert substance known as a placebo before they can be made available, which represents a "radical departure from past practices."
Most Americans, and indeed most consumers worldwide, understand that a placebo is a substance that is not biologically active and is completely inert. It is used to identify the number and type of adverse reactions that may occur compared to the test substance. In other words, a genuinely harmless substance is employed to assess the safety of the new drug or vaccine being introduced to the market.
As early as 2002, vaccine researchers raised questions about randomized, placebo-controlled trial design, highlighting ethical concerns regarding the participants in the control arm. Were they being deprived of "the benefits" of an existing vaccine? Furthermore, they challenged the scientific standard by questioning the gold-standard study hypothesis: Is an experimental vaccine more efficacious than one already in use?