The Secretary of Health and Human Services, Robert F. Kennedy Jr., will require new vaccines to undergo placebo tests, marking what a spokesman for the department called “a radical deviation of past practices.”
Policy change would force vaccines, to be approved for human use, to undergo studies in which half of the people in a study receive a placebo, usually a saline shot, to compare the results with the vaccine.
Placebo controlled tests are already used to test new medications or vaccines for safety and efficiency, but some experts consider that it is not ethical to perform such tests when a vaccine or treatment is already considered safe and effective. For example, they say, give half of the children in a trial a placebo for the measles vaccine when there is an already proven vaccine, those participants unnecessarily at risk of the virus.
It is not clear what a “new” vaccine considers HHS and if that includes flu and covid vaccines, which are updated annually to protect better against current circulating strains.
“The FDA Commissioner, Dr. Marty Makary, has indicated that significant updates to existing vaccines, such as those that address seasonal voltage changes or antigenic drift, can be considered ‘new products’ that require an additional clinical evaluation,” said Department spokesman for ABC News.
The Secretary of Health and Human Services, Robert F. Kennedy Jr., speaks during a press conference about the FDA’s intention to eliminate the use of oil synthetic dyes in the food supply of the Nation, in Washington, on April 22, 2025.
Oliver Contreras/AFP through Getty Images
But the spokesman indicated that the annual flu vaccine may not be affected by politics, calling it “judged and proven for more than 80 years.”
It seems, however, that politics could affect the launch of future COVID vaccines, which are updated annually.
When asked to prepare what the department considers a “new” vaccine, the spokesman said that federal health agencies would follow the “gold standard of science.”
Kennedy has long questioned the safety of vaccines and argued that placebo -based tests are needed to ensure that vaccines are no more damage than well.
Even when Miles died during the public health emergency of COVID-19, Covid vaccines still underwent placebo controlled studies with more than 100,000 volunteers from various populations. Experts say that practice is necessary to determine whether a vaccine is not only effective, but also safe.
A medical care worker delivers surgical gloves that pull a COVID-19 vaccine fluid from a vial to vaccinate a patient.
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Many children’s vaccines were originally tested with placebo trials. Others have been available for decades, providing data from millions of people who show that these vaccines are overwhelmingly safe and effective.
Once a vaccine for a disease is approved safely and effective, the future versions of the shot are tested in clinical trials against the shot already approved. Clinical trials prove if updated vaccines generate an immune response that is comparable or better than the previous versions of the vaccine.
Even after vaccines are made available to the public, scientists continue to monitor them for safety. They also review any report of side effects or reactions and share these facts with the public.
