A Renowned Vaccinologist and the Placebo-Controlled Clinical Trials That Weren’t

What do you think of when you hear “placebo-controlled clinical trial?”

Most people familiar with the term will understand it to be the standard way many drugs are tested in order to determine efficacy and safety before they are licensed and marketed to the general public.  It’s usually understood to involve a pharmacologically inactive or inert pill with no active ingredient producing no medical effect as part of a control group used to draw a comparison between it and the experimental drug under inspection. 

But if you thought that this is what is used to test the safety of vaccines, you’d be wrong.

Paul Offit, pediatrician and renowned vaccinologist, and ICAN (Informed Consent Action Network) lawyer Aaron Siri had a Twitter bout on the issue of placebos and vaccine safety in late June.  

The exchange began when Siri responded to a statement in Offit’s article, “Should Scientists Debate the Undebatable.”  Offit, whose article is a response to Robert Kennedy Jr.’s comments on the Joe Rogan Show, wrote “All vaccines are tested in placebo-controlled trials before licensure.”

Siri then responds to Offit with…

“Virtually all childhood vaccines on the CDC government schedule, including Rotateq (Offit’s invention, along with Fred Clark and Stanley Plotkin), were not licensed by US FDA based on a placebo-controlled trial.  Robert Kennedy Jr. is correct on that point. NYTimes, Stat News, Paul Offit, Peter Hotez are all dead wrong.”

Offit responds to Siri with a tweet indicating in part that “the purpose of placebos, which are immunologically inert, is to determine the effect of the vaccine.  All vaccines meet that standard.

It is at this point when Siri drops the hammer on Offit’s response. 

Siri explains that Offit’s revised definition of placebo as “immunologically inert” would focus on testing efficacy, not safety.

“Robert Kennedy was right when explaining that childhood vaccines are virtually never licensed based on a control group receiving an inert substance.

When, for instance, Merch’s Gardasil vaccine was tested, the control group did not receive a pharmacologically inert placebo but a pharmacologically active aluminum adjuvant, namely, amorphous aluminum hydroxyphosphate sulfate (AAHS).  The purpose behind the use of this aluminum salt in Gardasil is to cause an immune response to the antigen.  If that is the case, why is it in the placebo?

It turned out that after the trial they found that 2.3% of the subjects that received Gardasil and 2.3% of those who received the aluminum injection ended with a systemic autoimmune disorder, which the adjuvant can produce as test results show. So, as Siri explains, by not using a saline placebo…

“You ended up with a vaccine group and a control group with the same rate of harm. So for the purpose of FDA standards they are safe because they are equally harmful, but from the perspective any rational, normal- thinking, caring human being…not safe, not safe at all.”

To cite another example, Prevnar 7 was not tested against a saline placebo, either. But it served as the control for yet another vaccine – Prevnar 13. In this case results show that infants and toddlers developed serious adverse events following vaccination in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar 7 subjects.  This should have alarmed the FDA because the baseline safety for Prevnar 7 remained unknown. Attorney Siri explains this to Offit.  But Paul Offit says nothing about it in response. 

Interesting to note that after this exchange between the informed consent attorney and the vaccinologist, Paul Offit updated his original post from “All vaccines…” to “Most vaccines.”
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But to make matters worse, Offit’s remark is still false.  “Most” vaccines are not tested in placebo-controlled trials before licensure.  

The actual evidence is from the FDA itself.  For instance, take the Hepatitius B and DTaP vaccines.  Were there any placebo controls?

  • HepB vaccine (Birth 1M 6M)
    • Recombivax HB (Merck) licensed for babies based on trials with no placebo control & 5 days of safety monitoring after injection. See Package insert § 6.1
    • Engerix B (GSK) licensed for babies based on trials with no placebo control & 4 days of safety monitoring after injection. See Package insert  § 6.1
  • DTaP vaccine (2M 4M 6M 15M 4Y)
    • Infanrix (GSK) licensed for babies based on trials with no placebo control (DTP vaccine used as a control) & up to 30 days of safety review after injection. See Package insert § 6.1 (Note that DTP was not licensed in a placebo-controlled trial and increases mortality)
    • Daptacel (Sanofi) licensed for babies based on trials with no placebo control (DT or DTP vaccine used as control) & 2 months of safety review after injection except one trial which was 6 months with no control, 1,454 children and “[w]ithin 30 days following any dose of DAPTACEL, 3.9% subjects reported at least one serious adverse event.” See Package insert § 6.1 (see note for Infanrix)


The list of licensed vaccines without placebo control is staggering.  Siri lists them straight from the FDC (see the bottom of Siri’s article here.)  It’s also important to remember that known adverse effects are tucked away in the package insert 6.1 for each. 

Aaron Siri has, once again, cleared the air a bit by going toe-to-toe with a central figure in the world of vaccine development and distribution. 

It's amazing to observe someone who is a co-author of Plotkin’s Vaccines, current member of the FDA’s vaccine advisory committee and one who is frequently referred to in matters of vaccine safety, of all things, being handled so decisively by someone armed with the objective weapons of data and evidence.  The exchange, which includes a 17-part evidence-run tweeted by Siri started on July 25th, is unlikely to sway Offit much.  But it does bring to light essential things for us to know going forward. 

His match with Offit, along with what we know about the limitations of Congress’ 1986  National Childhood Vaccine Injury Act and its removal of liability for childhood vaccine injury;  Big Pharma’s lack of incentive to understand the safety profile for their vaccines before they are licensed; and the problems behind establishing causation between injury and vaccines without true placebo-controlled trials, inform us not to readily accept pronouncements from HHS and its agencies without objective input or rebuttal.  

Good to keep in mind as we advance toward the murky waters of proposed climate lockdowns, re-masking, re-vaxing, and whatever the upcoming presidential election might bring from tyrannical parties bent on control.

Victor Fernandez is a former Logic/Philosophy of Science adjunct and retired math teacher

Image: Pixabay / Pixabay License

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