• Posted May 2, 2025

RFK Jr. to Change Vaccine Testing Rules

FRIDAY, May 2, 2025 (HealthDay News) — U.S. Health and Human Services Secretary Robert F. Kennedy Jr. plans to change how vaccines are tested in the U.S., a decision that could impact how quickly and widely vaccines are made available.

The department said the new plan will promote transparency, but many health experts warn it could affect vaccine access and diminish the public's trust.

The change would require all new vaccines to undergo placebo-controlled trials before approval, The Washington Post reported.

That means some people would receive the vaccine and others would get an inert substance, like a saline injection, before the results are compared.

“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” an HHS spokesperson told The Post.

Doctors say this type of testing is already used for diseases like COVID. But for diseases like measles or polio, they argue it may be wrong to withhold vaccines from people in a placebo group when those vaccines have already been shown to be effective.

HHS has not explained how the new rule would be implemented or which vaccines it would affect. The flu shot would not be included since it “has been tried and tested for more than 80 years," the HHS said.

Experts worry that the new rule could require vaccines that are already tested to be retested, slowing down production and access, The Post reported.

“You are watching the gradual dissolution of the vaccine infrastructure in this country,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The Post. “The goal is to make vaccines less available and less affordable.”

Some experts say the statement from HHS comprises complete misinformation.

“To make a blanket statement like that, I think that would go against the science,” said Dr. Sean O’Leary, a pediatric-infectious-diseases physician.

Kennedy has also said he wants more "gold standard" science.

“HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability,” an HHS spokesperson told The Post.

But medical experts argue that the current system works fine.

Sen. Bill Cassidy (R-La.) said Kennedy had promised to keep working within current safety systems and to give notice to lawmakers before making any changes.

“The first vaccine for a disease is already proven safe through a placebo-controlled trial,” Cassidy said to The Post. “Updating that vaccine does not require a new placebo-controlled trial to determine its safety. To require a placebo group would deny those patients access to the vaccine that has already been found safe.”

Experts say some vaccines already went through placebo trials. For well-known diseases, researchers now use tests that measure immune responses instead of using placebos, which is considered more ethical.

“Ethics must be taken into account when you set up a study,” said Dr. Stanley Plotkin, a pioneer in the field who developed the rubella vaccine. “Can I ethically agree to having people acquire the disease because they receive a placebo?”

The concern is especially high as measles cases rise across the country, and some experts fear that Kennedy’s mixed messages are adding to the problem. Since becoming HHS secretary, he has not strongly supported vaccines during the measles outbreak, and Dr. Peter Marks, the nation's top vaccine official, resigned under the pressure.

Further, the new rules could also affect COVID vaccines. The Trump administration recently paused full approval of the Novavax COVID shot, asking for a new trial. Experts say the vaccine is not a new product and doesn't need anymore testing.

If more vaccine makers are required to run costly new trials, experts warn it could delay or reduce the number of vaccines that are available in the future.

“It’s just not correct. They obviously don’t understand how vaccines are approved and how one obtains safety data,” said Michael Osterholm, a University of Minnesota infectious-disease expert.

More information

There's more about vaccines at John Hopkins' Institute for Vaccine Safety.

SOURCE: The Washington Post, May 1, 2025