Informed Consent for Vaccines, and ICAN, Suing The FDA To Mitigate Even Worse Damage

November 2020

Safety

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), ICAN 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.

To solidify this gain, 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: AstraZeneca, Pfizer, Moderna, and Johnson & Johnson.  Those protocols revealed that some of ICAN’s demands regarding the duration for tracking vaccine safety had been met.

Not fully satisfied, ICAN filed superseding petitions for the four COVID-19 vaccines currently undergoing Phase III clinical trials in the United States on October 16, 2020.  A link to each petition is available here:  AstraZeneca, Pfizer, Moderna, and Johnson & Johnson.  Therein, ICAN repeats the vaccine safety demands that have still not been fulfilled.  These petitions detail the serious shortcomings in the current review of safety in the ongoing clinical trials of the leading COVID-19 vaccines.

Efficacy

Many Americans have been led to believe that a COVID-19 vaccine, when available, will prevent individuals from having a serious case of COVID-19 and will stop people from spreading it to others.  However, the clinical trials for Pfizer, Moderna, AstraZeneca, and Johnson & Johnson’s products are not designed to determine either of these!

Instead, each of the four trials’ primary goals for determining whether the vaccine is effective merely requires determination of whether it can reduce symptoms of mild cases of COVID-19.   The trials will also not demonstrate whether or not a vaccine recipient can still transmit COVID-19 to others.  This means that, under the current rules, a COVID-19 vaccine can be licensed without demonstrating it can prevent severe COVID-19, hospitalization, or deaths, nor stop the spread of COVID-19.

Also concerning is that “cases” of COVID-19 for trial purposes are being demonstrated by positive PCR tests.  The scientific literature has shown that such PCR tests can be highly unreliable, frequently giving false positives.  Consistent with this literature, we demanded that only positive PCR results meeting certain criteria be relied upon.  ICAN also demanded that all participants be tested before and after vaccination for T-cell immunity to SARS-CoV-2, which is not currently part of the protocols.  If a person has pre-existing immunity to SARS-CoV-2 (either from being exposed to COVID-19 or otherwise) their presence in the study could affect the result by showing fewer people getting sick than would actually occur in the “wild.”

These alarming deficiencies in the studies were what led ICAN to direct its attorneys to file a petition demanding that all four Phase III COVID-19 vaccine trials amend their efficacy endpoints.  ICAN demanded, among other things, that the trials test and determine (1) whether these vaccines will prevent severe cases of COVID-19; and (2) whether they will stop the spread of the virus.  ICAN further demanded improvements in the PCR testing protocol and T-cell testing pre-and-post vaccination.

Recognizing the critical importance that these changes be made in a timely manner, on November 11, 2020, ICAN’s attorneys filed a Petition for a Stay of Action with the FDA which asks that the agency stay, or pause, any action related to the trials until the requested actions in the efficacy petition are implemented.

The shortcomings in assessing the efficacy of a COVID-19 vaccine are incredible and, unless the endpoints for determining efficacy in these trials are corrected, will render any claim that a licensed COVID-19 vaccine is effective at preventing serious illness or transmission of the virus one abased on mere speculation.