Secretary of Health and Humanitarian Services Robert F. Kennedy Jr. It will require a new vaccine to undergo a placebo test, marking what spokesperson is called “radical departure from past practices.”
Changes in policy will force the vaccine, to be approved for human use, to undergo a study where half of the individual in a study receives a placebo – usually injection of copy – to compare the results with the vaccine.
Experiments controlled by placebo have been used to test new drugs or vaccines for safety and efficacy, but some experts consider it unethical to conduct the trial when the vaccine or treatment is considered safe and effective. For example, they said, giving half of the children in the placebo trial for the measles vaccine when the vaccine that had been proven would have placed the participants unnecessary at the risk of developing viruses.
It is still unclear what HHS considers as a “new” vaccine and whether it includes flu and covid vaccines, which are updated every year to protect better against the strain that is circulating.
“FDA Commissioner Dr. Marty Makary has indicated that significant updates for existing vaccines – such as those who discuss seasonal strain changes or antigenic deviations – can be considered ‘new products’ that require additional clinical evaluation,” the department spokesman told ABC News.
Secretary of Health and Humanitarian Services Robert F. Kennedy Jr. Speaking during a press conference about the FDA intention to erase the use of petroleum -based synthetic dyes in the country’s food supply, in Washington, April 22, 2025.
Oliver Contraras/AFP via Getty Images
But the spokesman indicated that the annual flu vaccine might not be affected by the policy, calling it “tried and tested for more than 80 years.”
It seems, on the contrary, that the policy can affect the launch of the Covid vaccine in the future, which is updated every year.
When asked to describe what the department was considered as a “new” vaccine, the spokesperson said that the federal health agent would follow the “Gold Standard of Science”.
Kennedy has long questioned the safety of the vaccine and argues that a placebo -based trial is needed to ensure that the vaccine does not do more damage than goodness.
Even when thousands of people were dying during the Covid-19 public health emergency, the Covid vaccine was still undergoing a study controlled by more than 100,000 volunteers from various populations. Experts say the practice is needed to determine whether the vaccine is not only effective, but also safe.
Hands of health care workers in surgical gloves that pull the covid-19 vaccine fluid from the bottle to vaccinate the patient.
Stock photo/picture getty
Many Kanak -Kanakak vaccines were initially tested with a placebo test. Others have been available for decades, providing data from millions of people who show that vaccines are very safe and effective.
After the vaccine for a disease is approved safe and effective, the future version of shots is tested in clinical trials of approved shots. Clinical trials test whether the updated vaccine produces an immune response that is proportional to or better than the previous vaccine version.
Even after the vaccine is available to the public, scientists continue to monitor them for safety. They also reviewed reports of side effects or reactions and sharing facts -this facts with the public.