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 didn’t provide citations.
Offit’s statements aren’t true.
Multiple vaccines licensed in the United States weren’t 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 7, or an influenza vaccine.
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 elsewhere 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 that “most vaccines are tested in placebo-controlled trials before licensure.” As of press time, he hasn’t updated his followers on Twitter, where he had been challenged by lawyer Aaron Siri.
Offit made a similar claim in 2017 in an op-ed for STAT News also challenging 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 didn’t respond to an inquiry. The article hasn’t been updated as of June 28.
Dr. Paul Offit in Beverly Hills, Calif., on July 23, 2014. (Frederick M. Brown/Getty Images)
More Than 1
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. He also said that none of the vaccines on the childhood vaccination schedule “have ever been tested pre-licensing 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 didn’t respond to a request for comment.
The HHS has claimed that “many pediatric vaccines have been investigated in clinical trials that included a placebo.”
Most vaccines for children either weren’t tested against placebos or were tested against placebos that don’t meet the FDA and CDC definitions.
That includes Prevnar 13, the hepatitis A vaccines, and the chicken pox vaccines.
The hepatitis A vaccines, for instance, were either tested against a group that received a hepatitis B vaccine or against a group that received aluminum hydroxyphosphate sulfate.
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—weren’t 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 with 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.”
Siri, who represents the Informed Consent Action Network, disagreed. The ingredients aren’t inert and shouldn’t be included, he told The Epoch Times.
Other vaccines were originally tested against a placebo, but newer versions weren’t.
When there’s an existing vaccine, comparing that with 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.
Robert F. Kennedy Jr. in Los Angeles on Feb. 6, 2023. (York Du/The Epoch Times)
Debate
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 guest on the show, to appear on the podcast with Kennedy to debate him.
Hotez declined, saying 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 said that Hotez shouldn’t debate Kennedy, who he said “doesn’t have solid data to support his claims.”
Offit pointed readers to a video by 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.”
