RFK Jr. to Require Placebo-Controlled Studies for New Vaccines

The Trump administration plans to require new vaccines to be tested against a placebo before being made available, sparking concerns among vaccine experts that this could delay the availability of future COVID-19 vaccines and undermine confidence in vaccination programs.

The decision, announced by Robert F. Kennedy Jr., secretary of Health and Human Services, has been met with alarm from medical professionals who claim it is part of an effort to undermine vaccine confidence. They argue that such testing has always been a standard practice for evaluating the safety and efficacy of vaccines, including COVID-19 shots.

“Testing new vaccines against placebos is not a radical departure from past practices,” said Dr. Paul Offit, a University of Pennsylvania vaccine expert. “It’s a crucial step in ensuring vaccines are safe and effective.”

However, experts dispute Kennedy’s claim that childhood vaccines have never been tested against placebos. Placebo trials have indeed been conducted for routine vaccines, including COVID-19 shots.

The administration maintains its new requirement is aimed at ensuring vaccine safety. However, critics argue that implementing such testing would be prohibitively expensive, time-consuming, and potentially detrimental to public health.

“A placebo-controlled trial would require huge amounts of data and resources,” said Dr. Jesse Goodman, a former Food and Drug Administration vaccine regulator. “It would take too long to produce the updated vaccines in time for next fall and winter.”

Experts also question the ethics of conducting such trials, given that an effective vaccine already exists. “Giving someone a placebo to protect them against a potentially deadly disease is unethical,” said Dr. Peter Hotez, a vaccine researcher.

The move has sparked concerns at a time when vaccination rates are falling, and diseases like measles are experiencing outbreaks.

Source: https://www.npr.org/sections/shots-health-news/2025/05/01/nx-s1-5383172/rfk-jr-placebo-vaccine-testing-studies