Legal Action

ICAN Demands FDA Require Placebo Control in COVID-19 Vaccine Trials

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The generals will tell you that wars are often won long before the battle actually begins or any shot is fired through planning, preparation, and foresight.  ICAN’s tireless work over the last three years with regard to all vaccines has had a significant impact on the ongoing clinical trials and potential approval process for COVID-19 vaccines. This update provides a bit of that history and describes some of ICAN’s legal efforts with regard to a COVID-19 vaccine.

Companies assure their products are safe because they do not want to be sued for damages or get fined by regulators.  When it comes to vaccines, however, neither of these checks exist.  Unlike other consumer products, the companies earning billions of dollars from vaccines cannot be sued for harms caused by their vaccines; and the federal department responsible for assuring vaccine safety — the United States Department of Health and Human Services (HHS) — does not fulfill this duty because it would conflict with its duty to promote vaccines and defend against any claim that a vaccine causes harm in vaccine court.

In short, there is nobody guarding the henhouse.  It is in this vacuum that ICAN began its work in 2017.  The logical place to begin was reviewing the clinical trials relied upon by the Food and Drug Administration (FDA) to license childhood vaccines. After conducting this review, ICAN sent a legal demand to HHS — the parent department of FDA — on October 12, 2017 asking it to “[p]lease explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?”

HHS responded on January 18, 2018, in a letter reviewed and approved by the FDA, claiming that “[c]ontrary to statements made on page two of your letter, many pediatric vaccines have been investigated in clinical trials that included a placebo.”  HHS’s response also claimed that safety in these trials was reviewed for a significant duration, without specifying any duration.  HHS and the FDA were about to have egg on their face.

ICAN responded on December 31, 2018 with a detailed chart containing every pediatric vaccine, citing to FDA documents, which indisputably proves that it was categorically false for HHS and the FDA to claim that “many pediatric vaccines have been investigated in clinical trials that included a placebo.”  The reality is that none – save one – of the pediatric vaccines was licensed based on a placebo controlled clinical trial!  ICAN’s response also pointed out the short safety review periods in these trials.  ICAN even graciously provided HHS and the FDA an additional opportunity to provide proof that these clinical trials did include a placebo control.  No proof has ever been provided.

This exchange between ICAN and HHS also covered a wide range of vaccine safety topics beyond the clinical trials used to justify licensure of pediatric vaccines.  HHS could not, for any of these topics, provide proof or assurance that vaccines are safe or that they have been properly safety tested.

To assure that every single scientist within the CDC, FDA, and NIH who has any involvement with vaccines knows about the information in these letters, ICAN sent every single one of those scientists their own package containing a copy of ICAN’s letter exchange with HHS.

ICAN has also continued to relentlessly pursue the FDA about the inadequacy of the clinical trials it relied upon to license the pediatric vaccines currently injected into millions of children.  For example, in a prior update, we explained our efforts concerning the only two Hepatitis B vaccines given to babies in America on their first day of life, including the petition we filed with the FDA demanding it withdraw the licenses for these vaccines until it conducts long-term placebo control trials of these products to assure their safety.  ICAN also sued the FDA numerous times to force it to release clinical trial reports for other vaccines, including, for example, the chicken pox vaccine, which we explained in another recent legal update.

The FDA is acutely aware that ICAN will not hesitate to sue if its reasonable demands regarding vaccine safety are ignored.  In that regard, when the Phase III trial for AstraZeneca and the University of Oxford’s COVID-19 vaccine was underway in England using another vaccine (Menveo) as a control (instead of a placebo), we filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control as well as track safety long-term in a properly sized trial.

Nine days after ICAN filed its petition, on June 30, 2020, the FDA changed course and issued emergency guidance to industry that all COVID-19 clinical trials must use a placebo control.

ICAN, however, was not done fighting to assure that these clinical trials are properly conducted.  On July 17, 2020, ICAN sued the FDA in federal court demanding the entire clinical trial report for Menveo, just in case the agency was considering permitting this vaccine as a control in the AstraZeneca trial to be conducted in the United States.  On July 20, 2020, ICAN also filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding, among other things, that it also require that these clinical trials track all adverse events during the entire duration of the trial – not just for a limited time period.

Not long thereafter, in mid-September, in a highly unusual move, the full clinical trial protocols for the COVID-19 vaccines for which ICAN filed its petitions were released to the public.  See copies for each of the manufacturer’s vaccines: AstraZenecaPfizerModerna, and Johnson & Johnson.  Those protocols revealed that some of ICAN’s demands regarding the duration for tracking vaccine safety had been met.

Just as the pharmaceutical companies will never rest when it comes to promoting and selling their vaccine products, we will never rest in exposing the truth regarding these products or in demanding full transparency and full informed consent for any and all vaccines.