Clinical Trial to License RotaTeq, Like Almost All Childhood Vaccines, Did Not Use a Placebo Control

Those attacking RFK are wrong.

Robert F. Kennedy, Jr. is on record stating that almost all childhood vaccines were licensed based on clinical trials that did not include a placebo control. He is correct.

Nonetheless, numerous news outlets, such as Stat News in its article titled “Correcting Robert F. Kennedy Jr.’s vaccine ‘facts’”, are stating Mr. Kennedy is wrong because they claim the clinical trial relied upon to license the rotavirus vaccine, RotaTeq, did include a placebo control. They are wrong.

A placebo is defined by the CDC as a “substance or treatment that has no effect on living beings.” This means a saline injection or water drops in mouth.

RotaTeq is administered via oral drops. A “placebo” would have been water drops in the mouth. The control used in the trial, however, included bioactive ingredients including almost all the ingredients in the RotaTeq vaccine itself.

How do I know this? Because in 2018, on behalf of ICAN, we were investigating the control used in each clinical trial relied upon by the FDA to license each childhood vaccine.

In that review, we found that while the package insert for the RotaTeq vaccine says the control in its clinical trial was a “placebo,” when we read the FDA’s clinical trial review for RotaTeq, the ingredients of this so-called “placebo” were redacted:

So, on behalf of ICAN we submitted a Freedom of Information Act Request to the FDA for “Documents sufficient to identify the ingredients of the ‘placebo’ in the prelicensure clinical trials identified in Section 6.1 of the package insert for RotaTeq.”

In a response dated June 14, 2018, the FDA provided the requested documents which clearly show that the control was not a placebo. Rather, it included polysorbate-80, sodium citrate, sodium phosphate, and sucrose.

These same four ingredients are also contained in RotaTeq. The only difference between the vaccine and the control is that RotaTeq also included tissue culture medium and rotavirus reassortments. So, bottom line: the control used in the RotaTeq clinical trial was not a placebo since it included bioactive ingredients.

For example, here is what the NIH explains about sodium phosphate, one of the ingredients in the control:

Sodium Phosphate can cause serious kidney damage and possibly death. In some cases, this damage was permanent, and some people whose kidneys were damaged had to be treated with dialysis (treatment to remove waste from the blood when the kidneys are not working well). Some people developed kidney damage within a few days after their treatment, and others developed kidney damage up to several months after their treatment.

And as these studies and data sheet make clear, polysorbate-80 is far from an inert substance, is bioactive, and can have safety concerns, especially when given to infants.

Bottom line, Robert F. Kennedy, Jr.’s claim that virtually all childhood vaccines were licensed based on clinical trials that did not include a control group that received a placebo is correct. The undisputable evidence for this claim, all from FDA or pharma sources, is detailed on pages 3 to 7 of a response we sent to HHS on December 31, 2018. (In sharp contrast to virtually all other childhood vaccines, the clinical trial relied on to license Pfizer’s Covid-19 vaccine for teenagers 12 to 17 years of age appears to have had a placebo control group, though we are still reviewing that claim.)

Here are copies of the charts from that 2018 response to HHS which show what the control group received in each clinical trial for each childhood vaccine:

It is also why the following claim by Dr. Paul Offit in his article “Should Scientists Debate the Undebatable” is categorically false: “All vaccines are tested in placebo-controlled trials before licensure.”

I would more than welcome a public debate with Dr. Offit on this point and would welcome being proven wrong – would gladly prefer that products injected into babies not have this safety gap. Oh, but wait, Dr. Offit says it is undebatable, which again shows precisely why there must always be complete, uncoerced choice when it comes to any medical product.

What is really incredible about the attacks on Mr. Kennedy is that he has made clear he has no intention of changing anyone’s right to obtain vaccines. Everyone who wants to keep vaccinating will be free to do so. He just wants to assure freedom of choice and help those who are injured by these products.

The media and medical profession’s attack on this position is callous. Just as they care about those injured by infectious disease, as Mr. Kennedy certainly does, they should also care about those injured by vaccines. Mr. Kennedy is clear that we can and should do both. And to his amazing credit, no amount of insult or attack has moved him from his position that we must protect every American, including those injured by these pharma products.