Many vaccines licensed in the United States were tested against other vaccines, rather than a placebo, HHS noted in 2018.
Health Secretary Robert F. Kennedy Jr. is requiring all new vaccines to be tested against placebos before being licensed, officials said on April 30.
The requirement is “a radical departure from past practices,” a spokesperson for the Department of Health and Human Services (HHS) told The Epoch Times in an email.
“Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products,” the HHS spokesperson said.
A placebo is a substance that “has no effect on living beings,” according to the Centers for Disease Control and Prevention. The Food and Drug Administration (FDA) defines it as an “inactive preparation.” Neither agency responded to requests for comment.
Many vaccines licensed in the United States were tested against other vaccines, rather than against a placebo, HHS acknowledged in a 2018 letter to the Informed Consent Action Network.
Federal regulators, who are part of HHS, have not approved any vaccines since Kennedy was sworn in as health secretary in February.
Prior to becoming health secretary, Kennedy chaired Children’s Health Defense, an organization that has raised concerns about virtually all vaccines. He told The Epoch Times in 2023 that vaccines “are not tested for safety against placebos in any kind of functioning trial prior to being approved.”
Some experts say that placebo-controlled trials for established vaccines, such as the measles, mumps, and rubella (MMR) shots, would not be ethical because it would deny participants in the control arm a vaccine.
“Inclusion of placebo control groups is considered unethical,” HHS said in the 2018 letter. Others say that placebo-controlled trials can be justified on an ethical basis.
Dr. David Wohl, a professor at the University of North Carolina at Chapel Hill’s Institute of Global Health and Infectious Diseases, told The Epoch Times in an email that he believes placebo-controlled trials are not ethical for infectious diseases for which there are vaccines.
“For infections where a vaccine does not exist, a placebo can be considered; however, this may not be ideal, as vaccines commonly cause side effects like soreness at the injection site or achiness as the body responds to the vaccine as intended,” Wohl, who worked on the trial for Pfizer’s COVID-19 vaccine, said. In those circumstances, the control group could receive an existing vaccine for another disease.
Aaron Siri, a lawyer who represents the Informed Consent Action Network, told The Epoch Times via email that “a clinical trial without a proper control cannot properly assess safety.”
The network created a chart summarizing the trials of vaccines on the CDC’s schedule.
“What hangs in the balance of these trials is the safety of a product typically injected into millions of healthy infants and children every year,” Siri said, noting that Congress gave vaccine manufacturers immunity from liability through the 1986 National Childhood Vaccine Injury Act.
“That is an incredible moral and safety hazard,” he said.
