RFK Jr. Revamps Vaccine Testing: Introducing Placebo Control Groups

( The Hill Health and Human Services Secretary Robert F. Kennedy Jr. is revolutionizing the process of vaccine testing.

The department will now mandate that all newly developed vaccines must go through safety evaluations via placebo-controlled trials. This means that within these tests, some participants will be administered the actual vaccine whereas others will receive an inactive substance such as saline, which helps assess the vaccine’s effectiveness.

The HHS described this modification as a "significant shift from previous procedures" aimed at boosting openness regarding medical items and vaccines.

A representative from HHS didn’t provide specifics on the implementation of the policy but mentioned that the department plans to "assess the information once firms file their applications." They also outlined what criteria the agency uses to classify a vaccine as new.

For newly emerging illnesses, vaccines might be evaluated using a placebo; however, this approach may not be logical when dealing with extensively studied conditions such as polio and measles, according to statements made by public health specialists to The Washington Post .

One exemption to this rule is COVID-19 booster shots, which have received authorization without undergoing human trials in order to address rapidly mutating new variants of the virus.

As previously mentioned, studies carried out four years ago on individuals lacking natural immunity are no longer adequate. Similarly, a study from four years back doesn’t provide automatic approval every year for new vaccines unless accompanied by fresh clinical trial data; this differs from the flu vaccine, which has undergone rigorous testing over eight decades," stated an HHS representative to The Hill. "The public requires clear information and top-tier scientific evidence—especially concerning developing products.

Kennedy has a lengthy record of being skeptical about vaccines and has claimed that they undergo sufficient testing. He has advocated for conducting placebo-controlled trials of vaccines. multiple times .

Nathaniel Weixel helped with this report.

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