ICAN FILES NUMEROUS CITIZEN PETITIONS TO THE FDA REGARDING THE SAFETY AND EFFICACY OF THE COVID-19 VACCINES

May 2020 – ICAN files a formal petition demanding the FDA include a placebo control group in all COVID-19 vaccine clinical trials and the FDA thereafter adopted this requirement.  

As of May 22, 2020, there was one Phase II/III clinical trial a potential COVID-19 vaccine but the control group for this trial was not receiving a placebo – rather it was receiving a meningococcal vaccine!

ICAN therefore filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control.

Nine days later, 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. The FDA also required that, as requested by ICAN, the size of the placebo group must at least match the size of the vaccine group. The result has been that the Phase II/III clinical trials for COVID-19 vaccines approved by the FDA since June 30, 2020 at least began with a placebo control group.

July 2020 – ICAN files a second petition demanding that the vaccine clinical trials track all adverse events for the duration of the trial.

On July 20, 2020, ICAN filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding that it also require that these clinical trials track all adverse events during the entire duration of the trial.  It also demanded that adverse events be tracked for at least 1 year for adults, 3 years for children, and 6 years for toddlers and infants.

October 2020 – ICAN files another petition regarding the viral vector vaccine made by Janssen/Johnson & Johnson.

On October 19, 2020, ICAN submitted a Petition specifically seeking actions related to the Johnson & Johnson/Janssen vaccine.  This Petition was submitted more than 4 months before the FDA granted the manufacturer emergency use authorization, allowing ample time for compliance.

The Petition requested similar safety requirements that ICAN sought in prior petitions but added two specific requirements for the Johnson & Johnson vaccine due to the fact that it is a viral vector vaccine: (1) germline transmission tests to be conducted for male participants; and (2) HIV incidence to be “monitored at the end of the study and for an appropriate follow-up period.”

On February 27, 2021, the same day the FDA granted emergency use authorization for this vaccine, the FDA replied to ICAN and denied its requests.  Not satisfied with the FDA’s explanations for the denial, ICAN submitted a Petition for Reconsideration on March 23, 2021 which asked that the FDA again review the concerns in the Petition and ICAN’s additional arguments.

November 2020 – ICAN files a petition demanding valid endpoints for determining whether a COVID-19 vaccine is effective.

On November 6, 2020, ICAN filed a petition demanding that the FDA require valid endpoints for determining efficacy in the COVID-19 vaccine trials currently being run by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson.  ICAN’s demands include that the vaccine be shown to prevent serious cases of COVID-19 (not just mild cases) and that it can stop transmission of COVID-19.

Alarming deficiencies in the vaccine clinical trials regarding efficacy endpoints and the use of unreliable PCR testing 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.

FDA responds and ICAN submits replies to the FDA’s deficient responses to its COVID-19 petitions calling for more stringent safety and efficacy requirements.

Despite the importance of some of ICAN’s demands to the FDA, the agency did not adopt those demands and ICAN pushed back.

Thirteen days after ICAN’s initial petition was filed demanding placebo-controlled trials, the FDA released a guidance document providing that the trials should include a placebo-controlled group.  ICAN then requested that the FDA confirm that the placebo arm will be maintained through the conclusion of the trial in order to maintain the integrity of the trial and the validity of the safety data produced by the trial.  ICAN also requested more comprehensive tracking of adverse events, larger sample sizes within the trials (especially for the pediatric population), and testing of T-cells pre- and post-vaccination.  The FDA denied these requests and ICAN followed-up to let the agency know this is unacceptable given the novel nature of these mRNA vaccines and the current unknowns related to safety.

The FDA also denied ICAN’s demands with regards to efficacy and ICAN did not accept the FDA’s refusal to require the vaccine manufacturers to determine whether the vaccine prevents infection and transmission as a primary endpoint.

These alarming deficiencies that still exist in the trials are what led ICAN to direct its attorneys to submit replies to the FDA’s responses and to continue to follow through with demands that will benefit the public.  Below is a listing of the Citizen Petitions, FDA’s responses, and ICAN replies:

ICAN Petition and the Requests in the Petition FDA Response ICAN Reply
Phase II-III COVID-19 Vaccine trials – June 17, 2020 a. Require all Phase II and III trials of vaccines against COVID-19 include a placebo control group (i.e., a placebo comparator group);

b. The placebo shall be a saline injection without anything added. If the vaccine and saline are visually distinguishable, opaque vials should be used;

c. The placebo control group shall be of at least equivalent size to the experimental group; and

d. All systemic adverse reactions, adverse events, serious adverse events, medically-attended adverse events, new onset medical conditions, and any other health issue arising or exacerbated post-vaccination shall be documented for each subject post-vaccination for a period of at least twelve months for adults, thirty-six months for children and teenagers, and sixty months for infants and toddlers.

FDA Response – December 11, 2020 ICAN Reply – March 3, 2021
Phase III Moderna COVID-19 Vaccine – August 17, 2020 a. any and all adverse events and reactions will be documented for the entire duration of the trial;

b. such documenting of adverse events and reactions shall last at least twelve months for adults, thirty-six months for children, and sixty months for infants and toddlers;

c. it uses an adequate sample size, appropriately powered, in order to (i) detect an increase in rare adverse events or, any untoward medical occurrence, whether or not considered vaccine related, and (ii) determine that the rate of adverse events from the vaccine will not exceed the rate of adverse events known to occur from SARS-CoV-2 in the group under review; and

d. participants are tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination.

FDA Response – December 18, 2020 N/A
Phase III Pfizer COVID-19 Vaccine – August 19, 2020 a. any and all adverse events and reactions will be documented for the entire duration of the trial;

b. such documenting of adverse events and reactions shall last at least twelve months for adults, thirty-six months for children, and sixty months for infants and toddlers;

c. it uses an adequate sample size, appropriately powered, in order to (i) detect an increase in rare adverse events or, any untoward medical occurrence, whether or not considered vaccine related, and (ii) determine that the rate of adverse events from the vaccine will not exceed the rate of adverse events known to occur from SARS-CoV-2 in the group under review; and

d. participants are tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination.

FDA Response – December 11, 2020 ICAN Reply – March 3, 2021
PHASE III JOHNSON & JOHNSON COVID-19 VACCINE – October 16, 2021 a. any and all adverse events and reactions will be documented for the entire duration of the trial;

b. such documenting of adverse events and reactions shall last at least twenty-four months for adults, thirty-six months for children and sixty months for infants and toddlers, or such longer duration as appropriate, and in no event end prior to the subject reaching eight years of age;

c. it uses an adequate sample size, appropriately powered, in order to (i) detect an increase in rare adverse events or any untoward medical occurrence, whether or not considered vaccine related, and (ii) determine that the rate of adverse events from the vaccine will not exceed the rate of adverse events known to occur from SARS-CoV-2 in the group under review;

d. participants are tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination;

e. germline transmission tests are conducted for male participants; and

f. HIV incidence will be “monitored at the end of the study and for an appropriate follow-up period” and the trial will “evaluate the levels and distribution of both vector and insert responses in target tissues where HIV acquisition is known to occur.”

FDA Response – February 27, 2021 ICAN Petition for Reconsideration – March 23, 2021
Efficacy of COVID-19 Vaccines – November 6, 2020 a. reduction in severe COVID-19 (i.e., hospital admissions, ICU admissions, and death) be a primary endpoint;

b. PCR tests used to qualify an event of COVID-19 for a trials’ endpoint use a maximum of 24 amplification cycles;

c. interruption of transmission (person-to-person spread) be a primary endpoint; and

d. participants be tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination.

FDA Response – December 11, 2020 ICAN Reply – March 3, 2021

ICAN is awaiting responses to additional petitions and will not stop applying the pressure until the FDA adequately does its job and takes a stand for the people of this country that are being asked, and some mandated, to roll up their sleeves.