NIH Officials Profiting from COVID-19 Vaccine

NIH OFFICIALS STAND TO EARN MILLIONS FROM MODERNA VACCINE

ICAN can now officially confirm that officials within the National Institute of Health (NIH) who are working to develop a vaccine for novel coronavirus (COVID-19) stand to personally earn millions of dollars from sales of this vaccine. 

 

When government officials will profit from the sale of a product, there is cause for concern regarding their licensure and promotion of that product.

The first vaccine for COVID-19 to begin trials in the United States is mRNA-1273.  This experimental vaccine was developed by Dr. Anthony Fauci’s National Institute of Allergy and Infectious Disease (NIAID), which is part of the NIH, along with a biotech company, Moderna Inc., the company that will sell this product to the public.

To receive a share of the profit from the sale of mRNA-1273, the inventors of this product within NIAID would submit an Employee Invention Report to the NIH Office of Technology Transfer.  Each inventor stands to receive a personal payment of up to $150k annually from the sales of mRNA-1273.  NIAID also stands to earn millions of dollars in revenue from the sale of mRNA-1273 in addition to what its inventors within NIAID earn personally.

Moderna will pay a license fee to NIAID (or its parent agency) to use its patents related to mRNA-1273 and a portion of those fees are then paid directly to the inventors within NIAID who developed those patents.

There are two patents for which the following six individuals in NIAID appear to be listed as inventors which relate to development of mRNA-1273:

  • Barney Graham, Deputy Director, NIAID Vaccine Research Center
  • Kizzmekia Shanta Corbett, Scientific Lead, NIAID’s Coronavirus Vaccine Program
  • Michael Gordon Joyce, NIAID
  • Hadi Yassine, NIAID
  • Masaru Kanekiyo, NIAID
  • Olubukola Abiona, NIAID

To confirm these findings, ICAN had its legal team obtain directly from NIH copies of the Employee Invention Reports submitted by NIAID officials with regard to the COVID-19 vaccine.  NIH has now produced those reports which confirm that the above individuals are indeed listed as inventors.  Hence, these individuals within Dr. Fauci’s NIAID, and their heirs, will each potentially earn millions of dollars personally from sales of mRNA-1273 over the next twenty years.  NIAID also stands to earn millions annually from the sale of this vaccine.

Given the potentially significant personal financial interests of individuals within NIAID, it may not be surprising that NIAID used taxpayer dollars to sponsor, assume responsibility for, and perform the first clinical trial of this vaccine.  There is a clear conflict in having NIAID, whose employees stand to potentially earn millions of dollars from this vaccine, overseeing and conducting the clinical trial for mRNA-1273.  This clinical trial information is what NIAID’s sister agency, the FDA, will then rely upon to license the mRNA-1732 for public use.

NIAID’s parent department, HHS, has also awarded $483 million to accelerate development of mRNA-1273, including to “fund the development of mRNA-1273 to FDA licensure and manufacturing process scale-up to enable large-scale production in 2020 [before licensure is granted].”  The U.S. Government has also already reached a $1.5 billion deal to purchase 100 million doses of mRNA-1273.  HHS has even granted those developing and selling this product, including NIAID and Moderna, broad immunity from liability for injuries caused by this product.

Dr. Fauci has been tirelessly promoting the mRNA-1273 vaccine that will potentially make individuals in his agency millionaires and will drive millions more dollars into his agency.  It should not be permissible that the federal department responsible for testing and licensing a product would include individuals who stand to earn millions of dollars from selling that product.  It creates conflicts of interest that can cloud the vision of the most clear-eyed individuals.

FDA Requires Placebo Control Following ICAN Demand

ICAN’S LEGAL EFFORTS WITH REGARD TO COVID-19 VACCINES

 

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: 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.

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.

Board Overseeing COVID-19 Trials has Serious Conflicts

The boards overseeing the COVID-19 vaccine clinical trials are supposed to be independent of pharmaceutical companies. ICAN’s intensive investigation into these boards has revealed conflicts of interest with pharmaceutical companies that are shocking to the conscience. ICAN, through its attorneys, has therefore filed a formal demand to remove these individuals from these boards.

The boards overseeing the COVID-19 vaccine trials are known as Data and Safety Monitoring Boards (DSMBs). As explained by pro-vaccine bioethicist, Art Caplan, regarding these DSMBs: “They’re very powerful. They’re key guardians of science and safety and are as important if not more important than the FDA.”

There are four potential COVID-19 vaccines that are currently in Phase III clinical trials in the United States. The clinical trials for three of these experimental vaccines – the ones to be sold by AstraZeneca, Moderna, and Johnson & Johnson – are being overseen by a DSMB created by the Dr. Fauci’s National Institute of Allergy and Infectious Diseases (the NIAID DSMB). The clinical trial for Pfizer’s experimental vaccine is being overseen by a different DSMB (the Pfizer DSMB).

The members of these DSMBs were selected in secret. They meet in secret. Their identities are supposed to remain a secret. This veil of secrecy has held with the exception of two members. The identity of the chairperson of the NIAID DSMB, Dr. Richard Whitley, was mistakenly revealed by his university in an announcement that has been scrubbed from its website. As for the Pfizer DSMB, made up of five individuals, one of its members, Dr. Kathryn Edwards, was apparently mistakenly revealed in a CBS article.

Selecting these individuals could only occur by turning a blind eye to their extremely troubling and blatant conflicts with pharmaceutical companies. For example, ICAN’s investigation has revealed that one or both these two doctors have been, among other things, consultants for Gilead Science, AstraZeneca, GlaxoSmithKline, Merck, Sanofi, Sequirus, La Roche, Allergan, Moderna, and Novartis; advisors to Merck, Bionet, GSK, and Pfizer; paid speakers for Connaught, Lederle-Praxis, Wyeth Lederle, Glaxo, and Novartis; paid millions of dollars from these companies; and, on the tab of these companies, wined-and-dined to hundreds of meals and taken dozens of trips to exotic destinations. Meaning, they have had duties to these companies as consultants and advisors, have been personally financially supported by them, and have been their mouthpieces to the public.

Nonetheless, the American public is constantly assured by Dr. Fauci, Secretary Azar, and other public health officials that the DSMB members are independent of pharmaceutical companies. For example, Dr. Fauci recently told the public that: “[P]eople need to understand that an independent body, the Data and Safety Monitoring Board, is beholden to no one, not to the president, not to the vaccine companies, not to the FDA. Not to me.”

Only those wearing blinders could give Dr. Whitley and Dr. Edwards the label “independent.” To head the “independent” DSMB, Dr. Fauci could have selected from a sea of potential scientists, many of whom have never consulted for a pharmaceutical company, were never on a pharmaceutical company speakers’ bureau, and have not had hundreds of meals and dozens of exotic trips paid for by pharmaceutical companies. Instead he chose Dr. Whitely as its head. Dr. Fauci makes a mockery of the term “independent” and calls into serious question his judgment and objectivity.

ICAN, through its attorneys, has therefore sent a demand letter to the Director of HHS, Director of NIAID, Director of the FDA’s CBER, the White House Coronavirus Task Force, and POTUS. This letter lays out in detail: the conflicts of interest that Dr. Whitley and Dr. Edwards have with pharmaceutical companies; the litany of lies told by Dr. Fauci and other public health officials regarding the supposed independence of the DSMBs; and demands that they “remove any member of the NIAID DSMB, including Dr. Whitley, who has ever been a consultant, has been on a speakers’ bureau, or has had meals or travel paid for by any pharmaceutical company.”

You can read the full demand letter here. When we receive notice that these and any other conflicts individuals have been removed from the COVID-19 vaccine DSMBs, we will update this webpage.

ICAN has also filed petitions with the FDA regarding the protocol being used in the Phase III trials for the leading COVID-19 vaccines. Links to copies of these petitions will be added to this page on or around October 16, 2020.

State Health Departments Forced to Remove False Information About COVID-19 Vaccines

NEW YORK AND MICHIGAN’S DEPARTMENTS OF HEALTH COMPLY WITH ICAN’S LEGAL DEMANDS AND REMOVE “MISINFORMATION” REGARDING THE COVID-19 VACCINES FROM THEIR PUBLIC MARKETING MATERIAL

 

Starting with New York, ICAN achieved another victory in its ongoing campaign to ensure the government does not spread false information about vaccines.  New York State’s Department of Health prepared a social media campaign pushing the COVID-19 vaccines.  One of the ads falsely stated that the vaccines “went through the same rigorous approval process that all vaccines go through” and that “the vaccine is safe and effective. It was approved by the FDA, the CDC, and by NY’s independent vaccine panel.”  ICAN, through its attorneys, wrote to Dr. Howard Zucker, Commissioner of New York State’s Department of Health, and to Governor Andrew Cuomo, demanding they remove the false graphics and messaging regarding COVID-19 vaccines.  They quickly complied and removed the relevant false messaging.

 

On January 26, 2021, ICAN’s attorneys sent a letter to NYS DOH and Governor Cuomo informing them that they were violating federal law.  As part of Governor Cuomo’s #VaccinateNY campaign, NYS’s COVID-19 website provides materials to encourage and “educate” people about the COVID-19 vaccines. The social media materials are meant to be shared by New Yorkers to help spread the word and included the following poster:

Above this social media graphic, Cuomo and the NYS DOH provide the following “Sample Message” for individuals to use on social media: “The vaccine is safe and effective.  It was approved by the FDA, the CDC, and NY’s independent vaccine panel. Let’s #VaccinateNY!”

This social media messaging – intended to be shared and spread widely – made the false claim that the FDA “approved” a COVID-19 vaccine.  This is categorically false.  There is no COVID-19 vaccine that has been “approved” by the FDA.  The only three COVID-19 vaccines currently in use are authorized by the FDA pursuant to an emergency use authorization (“EUA”).

In fact, the FDA authorization letters for the COVID-19 vaccines expressly provide that the vaccines are each “an investigational vaccine not licensed for any indication” and require that “[a]ll promotional material relating to the COVID-19 Vaccine clearly and conspicuously … state that this product has not been approved or licensed by the FDA.”

Moreover, one would imagine that the Commissioner of the NYS DOH and the Governor would know that the CDC does not “approve” vaccines and that it would be false for them to claim that the CDC approved any COVID-19 vaccine.  Even worse, the three COVID-19 vaccines are still undergoing clinical trials, hence they were also spreading misinformation when they claimed that these EUA authorized products “went through the same rigorous approval process that all vaccines go through.”

Amazingly, just a few weeks later, on February 19, 2021, ICAN’s attorneys had to send anther letter to the NYS Health Commissioner and Governor Cuomo informing them that the following Facebook page now also contained false information regarding the COVID-19 vaccine and demanded that it be removed:

 

The post stated that “no serious side effects related to the vaccines have been reported,” however this information is plainly false.  In the vaccines’ clinical trials, there were serious adverse events that the trial investigators found were not only be “linked” to the vaccines, but in fact related to the COVID-19 vaccines. For Pfizer’s vaccine, these include shoulder injury, ventricular arrhythmia, and lymphadenopathy.  For Moderna’s vaccine, these include intractable nausea and vomiting, facial swelling, rheumatoid arthritis, Dyspnea with exertion, peripheral edema, Autonomic dysfunction, and B-cell lymphocytic lymphoma.

Further, post-authorization, there have been numerous serious adverse reactions related to the COVID-19 vaccines. The CDC, for example, has acknowledged that serious vaccine side effects related to the COVID-19 vaccines have been reported, including “[a]naphylaxis, an acute and potentially life-threatening allergic reaction.” Additionally, in the approximately two months since these vaccines have been in use, the CDC’s Vaccine Adverse Events Reporting System (“VAERS”) has received just under 16,000 reports of adverse events following COVID-19 vaccination and over 3,000 reports of serious adverse events related to a COVID-19 vaccination through February 12, 2021.

The NYS Health Commissioner and the Governor should be aware of the above information safety information.   They nonetheless made the false claim that there are no serious side effects related to the COVID-19 vaccines when the data clearly shows otherwise.  Even worse, the three COVID-19 vaccines are still undergoing clinical trials, so the data on serious adverse events is still being collected.

New York State and Governor Cuomo needed to be fact checked.  We are pleased to tell you that, after being notified that failure to remove the inaccurate graphic and its false messaging would result in a lawsuit, New York State took it down.  This is another victory that should serve to remind New York State, Governor Cuomo, and others that someone is watching.  ICAN’s message should be heard loud and clear: you may not spread “misinformation” about vaccines.

As for Michigan, ICAN achieved a similar victory.  Michigan’s Department of Health and Human Services posted a graphic and accompanying message on its public Facebook page.  The text falsely stated that “on the journey to FDA approval, each COVID-19 vaccine had to pass through the same thresholds of research & testing as every other vaccine.”  It went on to include additional, incorrect information: “all three of the approved COVID-19 vaccines were proven to be safe and 100% effective in preventing hospitalization and death in the clinical trials.”  ICAN, through its attorneys, wrote to the Director and to the Chief Deputy of Health of MDHHS demanding they remove the false graphics and messaging regarding COVID-19 vaccines.  They quickly complied within 48 hours and removed the relevant false messaging.

 

Soon after ICAN successfully challenged the New York State Department of Health’s false social media messaging regarding COVID-19 vaccines, on March 8, 2021, ICAN’s attorneys sent a letter to Michigan Department of Health and Human Services (MDHHS) informing them that they were violating federal law.  MDHHS’ posted the following graphic and messaging on Facebook:

This social media messaging – intended for the public – made numerous false claims.  First, it claims that the FDA “approved” a COVID-19 vaccine.  This is categorically false.  There is no COVID-19 vaccine that has been “approved” by the FDA.  The only three COVID-19 vaccines currently in use are authorized by the FDA pursuant to an emergency use authorization (“EUA”).  In fact, the FDA authorization letters for both COVID-19 vaccines expressly provide that the vaccines are each “an investigational vaccine not licensed for any indication” and require that “[a]ll promotional material relating to the COVID-19 Vaccine clearly and conspicuously … state that this product has not been approved or licensed by the FDA.”

In addition, the three COVID-19 vaccines are still undergoing clinical trials, hence they were also spreading misinformation when they claimed that these EUA authorized products “had to pass through the same thresholds of research & testing as every other vaccine...”  ICAN had to point out to a health agency that the Fact Sheets for Recipients for each of these vaccines unambiguously state that the vaccines “ha[ve] not undergone the same type of review as an FDA-approved or cleared product.”

Further, the Facebook post claimed that all three vaccines’ clinical trials have proven to be “100% effective in preventing hospitalization and death.” This is also categorically false.  The FDA’s review memorandum on each of the vaccines lists as one of the “Unknown Benefits/Data Gaps” “effectiveness against mortality.”  The FDA makes clear: “A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality.”  Additionally, the FDA’s Review Memorandum for Moderna’s vaccine states: “There were no deaths due to COVID-19 at the time of the interim analysis to enable an assessment of vaccine efficacy against death due to COVID-19.”

It is also false to claim that these vaccines have been proven to prevent 100% of hospitalizations.  In the Moderna trial, one participant in the mRNA-1273 group, a participant >65 years of age who had risk factors for severe COVID-19, was hospitalized due to oxygen saturation of 88% on room air 2 months after receiving the second dose of vaccine.”  In the Janssen trial, in a post hoc analysis of all COVID-19 related hospitalizations starting 14 days after vaccination, including non-centrally confirmed cases, there were 2 cases in the vaccine group.  Likewise, the Pfizer trial reported two serious cases of suspected but unconfirmed COVID-19, both in the vaccine group, where both vaccine recipients were hospitalized.

Michigan’s Department of Health needed to be fact checked.  We are pleased to tell you that, after being notified that failure to remove the inaccurate graphic and its false messaging would result in a lawsuit, MDHHS responded and removed any reference to “approved” vaccines and to the completely false claim that the vaccines are 100% effective in reducing hospitalizations and death.”  This is another victory that should serve to remind MDHHS, and every other public health department, that someone is watching.  And if the FDA and our federal health authorities will not ensure that the public is receiving true and accurate information, ICAN will.  ICAN’s message should be heard loud and clear: you may not spread “misinformation” about vaccines.

To that end, the revised post, while clear of two false assertions, is still misleading:

ICAN’s attorneys sent another letter to MDHHS explaining that it is still not accurate to state that the COVID-19 vaccines “had to pass the same thresholds of research & testing as every other vaccine.”  Every other vaccine that MDHSS is referencing has been licensed and approved.  In stating that the COVID-19 vaccines have undergone the same review, MDHHS is not “clearly and conspicuously” stating that this product has not been approved or licensed by the FDA.  Quite the opposite is true.

Additionally, the post now states that the vaccines were “proven to be safe and effective.”  In fact, the FDA has stated this is not the case: “Based on the safety and effectiveness data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 18 years of age and older.”   It is highly misleading for a health agency to state in unambiguous terms what the FDA has not yet proven or stated itself.  We will keep you apprised of any response to the latest letter.

Again, in less than 48 hours, MDHHS’s post was again revised to remove the claim about the vaccines passing the same thresholds or research and testing as other vaccines, and currently reads as follows:

ICAN’s attorneys contacted MDHHS once more to explain that vaccines have not proven to be effective against death.  Importantly, ICAN also notified MDHHS that it had written to the CDC about its claim that the vaccines are “safe and effective” and demanding that the CDC refrain from making this statement at least until the FDA itself actually makes this claim.

When granting EUAs for the vaccines, the FDA concluded that:

Based on the safety and effectiveness data … it is reasonable to believe that [] COVID-19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of [] COVID-19 Vaccine outweigh the known and potential risks of the vaccine… (emphasis added).

Contrary to the CDC’s statements that “COVID-19 vaccines are safe and effective,” the FDA has not found nor stated that the vaccines are “safe and effective.”  Rather, since it has not yet been proven that they are safe and effective, a standard required for licensure, the FDA has never made this statement and would not make this statement until licensed.  Instead, as quoted above, the FDA has only concluded thus far that “it is reasonable to believe” they “may be effective” and that with regard to safety, only that at present it appears “the known and potential benefits … outweigh the known and potential risks.”

ICAN will continue to do the FDA’s job for it and ensure that the public is only receiving accurate and proven data about vaccines.

ICAN Petitions to FDA Regarding COVID-19 Vaccines

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.

FDA Fails to Rebut Science Reflecting COVID-19 Vaccines Can Modify Recipient DNA

THE FDA FAILS TO REBUT RECENT SCIENTIFIC PUBLICATIONS THAT COVID-19 VACCINES CAN MODIFY HUMAN DNA

 

ICAN, through its attorneys, wrote to Dr. Rochelle Walensky, the Director of the CDC, along with Peter Marks, director of the Center for Biologics Evaluation and Research, to demand that the FDA and CDC confirm whether or not they still maintain that COVID-19 vaccines cannot change human DNA.

 

On March 16, 2021, ICAN’s attorneys wrote to Dr. Walensky and Dr. Marks to inquire about viral vector COVID-19 vaccines and the CDC’s assertion that “[t]he genetic material delivered by the viral vector does not integrate into a person’s DNA.”

ICAN pointed out a recent study which explains that “studies have shown that replication-incompetent adenoviral vectors randomly integrate into host chromosomes at frequencies of 0.001-1% of infected cells” and asked that Dr. Walensky and Dr. Marks either provide the science to explain how these studies are incorrect or confirm removal of CDC’s contrary assertion.

On March 22, 2021, we received a two-sentence reply email from Sandra Cashman thanking us for our letter and our “interest in COVID-19 vaccines and viral vector technology” and directing us to “see the latest information on the COVID-19 response at https://www.cdc.gov/COVID-19/.”  This site also states that “COVID-19 vaccines do not change or interact with your DNA in any way.”

We, therefore, wrote again to follow-up on that request and to also bring the following study to their attention which indicates that segments of SARS-CoV-2 viral RNA can become integrated into human genomic DNA and that this newly acquired viral sequence is not silent, meaning that these genetically modified regions of genomic DNA are transcriptionally active (DNA is being converted back into RNA).

Due to the apparent inconsistencies, we asked that Drs. Walensky and Marks advise whether the CDC and FDA still maintain that it is not possible for the mRNA in the COVID-19 vaccines to integrate into a vaccinee’s DNA.  On April 19, 2021, ICAN again wrote to raise this same concern with specific application to the J&J COVID-19 Vaccine.

While the FDA and CDC has not hesitated to provide fulsome and lengthy responses to ICAN’s demands when it believes it has the science to rebut the claims asserted, it plainly does not have the science to provide such a response in this instance.  This raises serious concerns about the integrity and forthrightness of these agencies as well as the safety of the products they are pushing.

FDA Fails to Rebut Science Showing LNP in COVID-19 Vaccines Travel to the Brain

FDA FAILS TO REBUT EVIDENCE THAT LIPID NANOPARTICLES USED IN PFIZER’S AND MODERNA’S COVID-19 VACCINES POSE A SAFETY RISK

 

On January 5,2020, ICAN, through its attorneys, wrote to Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, to demand a response to the question of whether or not lipid nanoparticles used in both of the currently authorized COVID-19 vaccines are safe.

 

ICAN is aware that both Pfizer and Moderna have used lipid nanoparticles (“LNPs”) in their vaccines – LNPs are what the manufacturers use to surround the RNA so that it does not fall apart when injected and before reaching its target cells.  Some have compared these LNPs to a fatty envelope or a delivery vehicle to get the mRNA into the human body in one piece.

A concern arose when ICAN was alerted to a study published in 2018 titled Lipid Nanoparticles: A Novel Approach for Brain Targeting.  The study states: “…lipid nanoparticles are taken up readily by the brain because of their lipophilic nature. The bioacceptable and biodegradable nature of lipid nanoparticles makes them…suited for brain targeting.” The article also states, “these nanostructures need to be investigated intensively to successfully reach the clinical trials stage.”

ICAN wants to fully understand whether the evidence that these LNPs are easily taken up and end up in the brain is a safety concern with these two particular vaccines. ICAN, through its attorneys, has therefore sent a letter to Dr. Peter Marks, the Director of the Food and Drug Administrations’ Center for Biologics Evaluation and Research.  Dr. Marks has referred to himself as “the FDA point person on COVID-19 vaccines” and has assured Americans that the FDA “will make sure they’re safe and effective.”

ICAN therefore asked Dr. Marks: If LNPs from the vaccine, which contain mRNA, are entering brain tissue, and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern for vaccine recipients?  ICAN asked Dr. Marks to consider the question posed and provide support for the substance of any response he provides.

On February 19, 2021, Dr. Marks provided a two-page response letter.  While it said a lot of random things about COVID-19 vaccines, it failed in any way to answer the question posed in our opening letter: “If LNPs from the vaccine, which contain the mRNA, are entering brain tissue and an immune reaction is occurring during the second dose to these LNPs, does this pose a safety concern to vaccine recipients?”

ICAN, through its attorneys, therefore sent a follow-up letter to Dr. Marks on March 12, 2021 which again asked him to answer this question.  It also provided an additional study conducted by Moderna which showed that intramuscular injection of mRNA vaccine resulted in its delivery into the brain.

As of May 5, 2021, the date this post is written, there has been no response.

The lack of response to this inquiry from Dr. Marks is highly concerning and we sure hope that he stands by his promise that he and the FDA “uphold globally respected standards for product quality, safety, and efficacy” and his statement that he would resign if “something that was unsafe or ineffective [] was being put through.”

Successful Challenges to Employer/University COVID-19 Mandates

EMPLOYERS RETRACT COVID-19 VACCINE REQUIREMENTS

 

During the period that they only had emergency use authorization, ICAN directly provided support to legally challenge any employer that required a COVID-19 vaccine.

ICAN’s legal team send out innumerable letters to employers and universities across the country that announced COVID-19 mandates for this unlicensed product.  For example, here is a letter that was sent to Cornell.  ICAN has also supported numerous lawsuits, including one that resulted in the employer dropping the mandate within hours of filing suit.  These efforts garnered publicity and made widely known that it is not legal to require an unlicensed vaccine and that the threat of a lawsuit for doing so was real.

We are confident that our efforts have played a major role in holding the line with regard to employee and university mandates of this unapproved and unlicensed vaccine.  The win can be measured by the fact that virtually no large corporations, putting aside a handful of hospitals and care facilities, have required this unlicensed vaccine and have typically indicated they will wait at least until it is approved and licensed by the FDA to consider a mandate.

With that accomplishment, ICAN turned its resources to fighting the next battle: licensure of the vaccine and vaccine passports.  You can read more about that in other portions of the COVID-19 section of this website.

Successful Challenges to Mask Mandate

ICAN SUPPORTED LEGAL REPRESENTATION RESULTS IN COMPLETE DISMISSAL OF MASK CITATIONS IN FLORIDA

 

ICAN supported the defense of two individuals who were cited for not wearing a mask in Broward County, Florida.  The attorneys that regularly represent ICAN appeared at a hearing in Broward County, Florida and argued against the unconstitutional mask mandate.  The hearing officer found one of the citations invalid based on a medical exemption, however, upheld the other individual’s citation.  ICAN’s legal team then appealed that decision to a Florida court arguing that the mask mandate was illegal.  Shortly thereafter, on May 6, 2021, Broward Country, Florida withdrew the violation! 

 

On September 15, 2020, a group of medical freedom advocates organized and participated in a demonstration in a Target in Fort Lauderdale, without their masks, and encouraged others to “breathe freely”, “take of your masks”, and stated “it’s all about choice!”  Broward County Code Enforcement later issued violations to some of the individuals that participated in this public medical freedom demonstration.

A hearing was held on February 19, 2021.  The attorneys that regularly represent ICAN appeared at the hearing for two of these citations.  They argued that the citations should be dismissed for three reasons:

  • Third, mask mandates violate fundamental individual freedoms that are protected by the federal and state constitutions, including an individual’s right to informed consent and due process.

Following presentation of this evidence, the hearing officer found one ticket to be valid and a fine was imposed.  The government’s attorney argued that, due to Governor De Santis’ Executive Order suspending individual fines, this fine could not be collected now, however, he stated that once the emergency orders are lifted, the County will seek to collect the fine.  ICAN  supported the  appeal of this decision to a Florida court and on May 6, 2021, the government folded and, pursuant to a stipulation, the citation was withdrawn.  This is another win for freedom!

ICAN will continue to support freedom advocates that stand up to tyranny and the deprivation of constitutional rights.  The trampling of these rights will continue, harden, and eventually become entrenched unless we stand up and say – enough!  Being brave is an American tradition and the core of the foundation of this nation.  As Benjamin Franklin stated and warned: “They who can give up essential liberty to obtain a little temporary safety deserve neither liberty nor safety.” ICAN stands the brave to fight the inching away of our liberty.

ICAN Exchange with EEOC Regarding Employer COVID-19 Mandates

THE EEOC HAS NOW STATED TO ICAN THAT ITS COVID-19 VACCINE GUIDANCE “ONLY ADDRESS COVID-19 AS IT IMPACTS THE ANTI-DISCRIMINATION LAWS ENFORCED BY THE EEOC” AND OTHERWISE DEFERRED TO THE FDA’S EUA PAGE WHICH PROVIDES THAT EUA COVID-19 VACCINES ARE OPTIONAL

ICAN, through its attorneys, reached out to the EEOC multiple times to request that the agency make its COVID-19 guidance clear and in line with federal law and the CDC and FDA’s position, which all provide that vaccines in use pursuant to Emergency Use Authorization cannot be mandated.  On April 22, 2021, the EEOC finally stated that: “The EEOC’s materials only address COVID-19 as it impacts the anti-discrimination laws enforced by the EEOC.”  On May 12, 2021, the EEOC’s Office of Legal Counsel further confirmed that “other federal and state laws govern COVID-19 vaccinations of employees” and “[a]ccordingly, those seeking more information about the legal implications of EUA or the FDA approach to vaccines can visit the FDA’s EUA page.

 

In December 2020, just days after the first COVID-19 vaccine had been issued emergency use authorization, the EEOC released a guidance titled “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.”  This guidance includes a section on vaccinations.  Throughout its questions and answers, the guidance discusses vaccines that have been “approved” or “authorized.”  However, in the questions dealing with employer mandates of COVID-19 vaccines, the EEOC discusses mandates when vaccines “are available” with no mention of authorization or approval status.  This caused confusion as it was being interpreted by some employers to mean that they may require the COVID-19 vaccines while they are in use pursuant to emergency use authorization.

ICAN, through its attorneys, sent  a letter on March 17, 2021 to the EEOC advising it of the relevant federal law regarding informed consent and emergency use authorization, and to clarify in response that its guidance was not addressing whether an employer can mandate a EUA authorized COVID-19 vaccine.

As explained to the EEOC, the same section of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”  Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

In light of this, ICAN asked the EEOC to clarify its guidance.  After receiving no response or acknowledgement from the EEOC, on April 19, 2021, ICAN again wrote to the EEOC with the same request.  After this second letter, ICAN received a response from the EEOC, dated April 22, 2021, confirming that “[t]he EEOC’s materials only address COVID-19 as it impacts the anti-discrimination laws enforced by the EEOC” and therefore, the EEOC’s advice and guidance regarding COVID-19 vaccines relate solely to “employment discrimination based on race, color, religion, sex (including pregnancy), national origin, age (40 or older), disability, or genetic information.” Therefore, its guidance does not account for the prohibition on requiring an emergency use authorized product in 21 U.S.C. § 360bbb-3.

On April 27, 2021, ICAN sent a third letter to the EEOC informing the commission that ICAN would publicize its response, including that the EEOC’s advice does not account for 21 U.S.C. § 360bbb-3 which prohibits employers from requiring the COVID-19 vaccine, unless the commission had any further clarification or comment prior to our doing so.  ICAN received no objection from the EEOC.

Subsequently, on May 12, 2021, ICAN received a response from the  Office of Legal Counsel to the EEOC.  The response letter makes clear that the EEOC’s guidance only applies to specific labor law provisions and, importantly, that the guidance does not address other laws, such as the federal law related to EUAs which prohibits requiring an EUA product such as a COVID-19 vaccine.   The EEOC’s legal counsel even cites to the FDA’s EUA page for additional information in that regard.  The FDA page states that, “FDA must ensure that recipients of the vaccine under an EUA are informed… that they have the option to accept or refuse the vaccine.”  The FDA page cited by the EEOC also links to the EUAs themselves which, in turn, approved the prescribing information which makes clear that administration of a COVID-19 vaccine must remain the choice of the recipient.  Hence, any interpretation of the EEOC’s guidelines as the federal government condoning mandates of an EUA product is clearly misplaced.

Companies Selling COVID-19 Vaccines Have No Liability for Injuries

The Secretary of the United States Department of Health & Human Services (HHS), Alex M. Azar III, has granted the companies selling and those involved in virtually any other activity related to any COVID-19 vaccine immunity from liability for any injuries caused by these products. Prior to his current position, Secretary Azar was a senior executive for a major pharmaceutical company, Eli Lilly and Company, from 2007 to 2017.

Secretary Azar has issued a “Declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.” (85 FR 15198.) It provides that those that “prescribe, administer, deliver, distribute or dispense” and the “manufacturers [and] distributors” of “any vaccine, used to treat, … prevent or mitigate COVID-19” shall enjoy “[l]iablity immunity ,” including, “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a [COVID-19 vaccine].” (Id.; 42 U.S.C. § 247d-6d.)

An integral driver of consumer safety is the potential and actual liability companies face if their product causes harm. To assure consumers that a pharmaceutical company stands behind the safety of its vaccine product, ICAN makes a public request that each pharmaceutical company formally declaration that it waives the immunity from liability granted by HHS for injuries caused by COVID-19 vaccine.

Waiving this immunity will provide the standard and minimal level of product safety assurance consumers expect. If a company will not bear the risk of having to pay for injuries caused by its product, it should be understandable that consumers will not want to bear the risk of being injected with that product.

The following a list of the pharmaceutical companies that have, to-date, publicly announced that they will stand-behind their product and waive immunity from liability for injuries caused by their COVID-19 vaccine:

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