RFK Jr. wants placebo testing for ‘new’ vaccines, some experts say it’s unethical

The health department did not provide details on how the proposed changes will be enforced or to which vaccine trials they will apply.

The U.S. health department, under the guidance of Health Secretary Robert F. Kennedy Jr., says it intends to add the requirement of a placebo testing phase in vaccine trials to provide more transparency about medical products, but experts warn the process could threaten immunization access and create public mistrust in the efficacy and validity of inoculations.

In a statement to the Washington Post this week, a spokesperson for the Department of Health and Human Services (HHS) said, “All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices.”

If implemented, the new regulations would require some test subjects to receive vaccine doses, while others would be injected with a non-reactive substance.

Vaccines that target new infectious agents are often tested using the placebo method, but for well-known and researched diseases, health experts say using a placebo poses ethical issues because the group receiving it will not know if they are actually protected against the illness.

The health department did not provide details on how the proposed changes will be enforced or to which vaccine trials they will apply. It also did not define what it meant by “new vaccine,” though it said the policy would not include the flu shot, which is updated yearly.

Health experts have argued that updated COVID-19 vaccines may be included, which they say could delay access.

Peter Lurie, a former Food and Drug Administration (FDA) official, told the BBC, “It’s hard to tell exactly what is being proposed.”

“But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point.”