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Not all of the vaccines licensed in the United States were tested against placebos, vaccine inventor Dr. Paul Offit has acknowledged.
Offit, who helped invent the rotavirus vaccine and co-authors a regularly updated tome on vaccines, recently claimed that the vaccines approved by the U.S. Food and Drug Administration (FDA) are tested in placebo-controlled trials.
“All vaccines are tested in placebo-controlled trials before licensure,” Offit wrote in a June 22 Substack post, addressing statements made by presidential candidate Robert F. Kennedy Jr. on a podcast. Offit also said on Twitter that all vaccines are tested in trials against “immunologically inert” controls. He did not provide citations.
Offit’s statements are not true.
Multiple vaccines licensed in the United States were not tested against placebos.
That includes Prevnar 13, a vaccine licensed to prevent pneumococcal disease.
In the trials the FDA cited when it licensed Prevnar 13, the control groups either received an older version of the vaccine, called Prevnar, or an influenza vaccine.
Prevnar, sometimes known as Prevnar 7, was approved after being compared in a trial with another vaccine, an investigational shot that targeted meningococcal disease.
The control group “received another experimental vaccine, rather than a placebo,” scientists with the FDA and U.S. Centers for Disease Control and Prevention (CDC) said in a paper about the vaccine.
“I hadn’t remembered that one,” Offit told The Epoch Times.
The CDC defines a placebo as “a substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.” The FDA defines it as an “inactive preparation” or as an “inactive pill.” Placebos are typically defined as “as an inert substance with no pharmacological action.” The World Health Organization has stated (pdf): “A true placebo is an inert substance, but in the context of vaccine research, the term placebo is also applied to other types of comparators that are not inert, but are not expected to protect against the disease of interest in a vaccine trial.”
The U.S. Department of Health and Human Services (HHS), which includes the FDA, has previously said (pdf) that not all vaccines licensed in the United States have been tested against a placebo. “Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required,” the department stated. “In some cases, inclusion of placebo control groups is considered unethical.”
Offit updated his post to state, “most vaccines are tested in placebo-controlled trials before licensure.” He has not updated his followers on Twitter.
Offit made a similar claim in 2017, writing in an op-ed for STAT News in another challenge to remarks by Kennedy.
“The FDA does require placebo-controlled trials before licensure,” Offit wrote. He linked to an interview with Kennedy in which STAT writer Helen Branswell said that all the vaccine trials she’d read were placebo-controlled.
STAT News did not respond to an inquiry. The article has not been updated as of June 28.
More Than One
On Joe Rogan’s podcast, Kennedy said vaccines “are exempt from pre-licensing safety testing.
“They don’t have to be tested. And they’re not,” he said, adding later: He also said that none of the vaccines on the childhood vaccination schedule “have ever been tested prelicensing in a placebo-controlled trial where you’re looking at vaccinated versus unvaccinated kids and looking at health outcomes.”
Kennedy made similar claims during a previous interview with The Epoch Times.
Some vaccines, though, have been tested against placebos.
That includes COVID-19 vaccines and Gardasil-9, a human papillomavirus vaccine.
Kennedy’s campaign did not respond to a request for comment.
At the same time, an HHS claim that “many pediatric vaccines have been investigated in clinical trials that included a placebo” is not supported by the data.
Most vaccines for children either were not tested against placebos or were tested against placebos that don’t meet the FDA and CDC definition.
In addition to Prevnar 13, that includes the hepatitis A vaccines and the chicken pox vaccines.
A larger number of vaccines for adults, including influenza vaccines, have been tested against placebos.
The Informed Consent Action Network in 2018 notified (pdf) HHS that all but one of the vaccines on the childhood vaccination schedule—Gardasil-9 was the exception—were not tested against a placebo that met the CDC definition. That prompted the HHS reply.
Some of the trials were described as comparing a vaccinated cohort to a cohort that received a placebo, but the latter actually received all of the vaccine ingredients except for the antigen.
Those count as placebo-controlled, Offit argued.
“The antigen is the variable,” Offit said. “You want to see whether or not the antigen is making a difference.”
Aaron Siri, a lawyer who represents the informed consent network, disagrees. The ingredients are not inert and should not be included, he told The Epoch Times.
Other vaccines were originally tested against a placebo, but newer versions were not.
When there’s an existing vaccine, comparing that to a newer version makes sense, Offit said.
“You can’t have a placebo group that doesn’t get that vaccine. It’s unethical,” he said.
Offit was writing after Kennedy’s appearance on the Rogan podcast sparked pushback from Dr. Peter Hotez, a vaccine scientist who decried Spotify for failing to “stem Joe Rogan’s vaccine misinformation.”
Rogan responded by offering $100,000 for Hotez, a previous participant on the show, to come back on the podcast with Kennedy to debate him.
Hotez declined, alleging that scientists “don’t typically do debates.”
Offit, who has met with Hotez before, wrote that Rogan’s episode was “packed with dangerous and misleading information,” and suggested Hotez should not debate Kennedy, who he said “doesn’t have solid data to support his claims.”
Offit pointed readers to a video by Dr. Dan Wilson, who runs a YouTube channel called Debunk the Funk. Wilson sought to address claims Kennedy made. After he played a clip of Kennedy’s remarks on placebo testing, Wilson falsely said that “every first vaccine before it goes to market is tested in randomized, double-blind, placebo-controlled trials.”