By: Vivek J
August 18 2023
All vaccines approved for children in the U.S. are subject to various rigorous trials pre-approval, including placebo-controlled trials.
A video found on TikTok features Robert F Kennedy Jr., also known as RFK Jr., claiming that “No vaccines have been ever tested.” RFK Jr. is known for making false claims about vaccines and their safety over the years. In this video, RFK Jr. claims, "None of the vaccines in the childhood vaccine schedule have been subject to placebo-controlled trials pre-licensing.” He went on to say that the Health and Human Services (HHS) was not able to provide a single safety study (pre-licensing) for any vaccine on the childhood schedule. RFK Jr. further said that the HHS has admitted that not a single vaccine in the childhood schedule had been safety tested pre-licensing.
However, claims that none of the vaccines are safety-tested against placebo-controlled trials are false.
Logically Facts found no evidence that the HHS has admitted that childhood vaccines have not been safety-tested.
In April 2018, the Informed Consent Action Network (ICAN), currently headed by RFK Jr., filed a lawsuit against the U.S. Health and Human Services claimed that HHS was stonewalling and not providing the required documents pertaining to vaccine safety sought under the Freedom of Information Act. This lawsuit was filed at the U.S. District Court for the Southern District of New York on April 12, 2018.
Logically Facts accessed the response filed by the HHS dated June 1, 2018, where the HHS admitted to allegations of being unable to provide the requested information. However, none of the documents contain admissions by the HHS pertaining to the allegations made on vaccine safety. This lawsuit was reportedly dismissed on July 9, 2018, after an agreement was reached between both parties.
What is a placebo-controlled safety study?
A placebo-controlled study is where there is more than one group of subjects, with one group being studied with a real dose of vaccine or medication while the other group is given a placebo. A placebo is an inactive solution with no effects of the medication under trial and cannot cure the disease. This allows medical professionals to compare the effects of the medication to the placebo.
A spokesperson for the U.S. Food and Drug Administration (FDA) told Logically Facts, “All FDA-approved and authorized vaccines have undergone the FDA’s thorough review process and have met the FDA’s rigorous standards for safety, effectiveness, and quality.” The FDA response further noted, “During vaccine development, clinical studies typically include a control group consisting of people who may receive an FDA-approved vaccine (active control), a placebo, or another substance. People receiving the vaccine under clinical study are compared to people in the control group.”
Vaccines used for children have undergone rigorous clinical trials, including placebo-controlled trials, both pre-licensure and post-licensure. For example, The FDA’s website has detailed information on the pre-licensing and post-licensing case studies and trials conducted for the Rotavirus vaccine for children named Rotarix, manufactured by GlaxoSmithKline (GSK). These observations also show the adverse effects of these vaccines that were observed during the trials. According to the FDA, placebo-controlled studies have been conducted for several of these vaccines pre-licensure.
Similarly, back in 1954, a clinical trial for a polio vaccine was conducted with over a million children involved in the process. A placebo-controlled study was conducted by providing simple salt solutions to several children to evaluate the efficacy of this trial.
Publicly available documents contain details of clinical trials and case studies (both pre-licensing and post-licensing) of vaccines approved in the U.S., including those approved in the childhood schedule. While placebo-controlled studies are not mandated by the FDA, there are several studies involving placebo-controlled studies too. Thus, it would be incorrect to say that vaccines have not been tested using a placebo-controlled study pre-licensure. Therefore, we have marked this claim as false.