by Xavier A. Figueroa, Ph.D
To the President of the University of Washington, Members of the Board of Regents of the University of Washington,
I write today as an alumnus of the University of Washington, a doctoral-level graduate from the program in Neurobiology & Behavior, from the Department of Environmental Health & Toxicology in the School of Public Health.
The reason for my writing this letter is my concern over the recent decision by President Anne-Marie Cauce to require students to get one of the three experimental COVID19 therapies in order to enter campus. In her recent email to the UW community (Protecting our community’s health by requiring students to be vaccinated, May 3, 2021) she outlines her plans for requiring students to take FDA non-cleared COVID19 therapies as a prerequisite for attendance.
I need to bring to the attention of the President and the Board of Regents several critical and potential material omissions to the statements in the email.
1. Your email stated: “Widespread vaccination is the only real way we can put the COVID-19 pandemic behind us and return to a more normal way of living, learning and working.”
As a matter of public health policy and scientific rigor, vaccination is only one tool that can be used to stop the spread of a community infection, but the unrealistic goal of stopping an airborne virus runs counter to all published public health and scientific publications. Natural occurring immunity, the use of effective and proven interventions (HCQ, Ivermectin and Chlorine Dioxide interventions) and proven public health measures (stay home if you are sick, wash hand, cover coughs, etc…) are effective and proven ways to protect the community. We now have an new endemic coronavirus in our virome and we need to treat it as such, not generate a long-march into the highly expensive and guaranteed-to-fail approach we are currently navigating.
2. Your email stated: “Fortunately, vaccines are now readily available that have proven safe and highly effective, including through clinical trials in which our own faculty collaborated and during real-world experience.”
The statement of the COVID19 therapies being safe and highly effective is not a scientifically or legally defensible position, from a due diligence stand-point. The current roll-out of the Pfizer/Bio-N-Tech, ModeRNA and J&J therapies are only occurring due to an Emergency Use Authorization (EUA) implementation. The reality for all three COVID19 therapies is that they are part of a continuing Phase 2/3 clinical trial. Efficacy of preventing transmission has not been the goal of these trials, as stated in the Lancet and BMJ publications, but to determine the effectiveness in reducing symptoms and generate a preliminary safety profile. The ability to stop the spread or transmission of SARs-Cov-2 has not been proven or demonstrated. That is why the trials are scheduled to finish in 2023. Effectiveness had not been proven, only proxy measures of immunity (antibody-titers) have been produced.
Critical to correcting the statement by Dr. Cauce, the safety profile as reported by Pfizer/Bio-N-Tech, ModeRNA and J&J are preliminary and in question. Reports from public media, social media and other non-governmental sources are compiling a record that runs counter to the information that is being provided by the CDC, the Department of Health for WA state and the statements produced by the manufacturers of the COVID19 therapies. Recent reports at the Vaccine Adverse Events Reporting System (VAERS) (a CDC managed, passive reporting system) has shown that there is a 20X increase in death reports in the period directly after the EUA program for COVID19 shots. These are not small or insignificant numbers, as review of VAERS reporting has demonstrated that the deaths and adverse events (AEs) are 1%-10% of the estimated, true numbers. The true deaths and AEs are absolutely under-reported. The number of deaths, AEs and hospitalizations could be in the tens to hundreds of thousands due to the COVID19 therapies. When we look through the historical data for VAERS, vaccines that have been around for decades do show a steady state of deaths, adverse events and hospitalizations. In the first 6 months of the COVID19 EUA program, the deaths, AEs and hospitalizations are higher than all incidences of other vaccines on the market for the past 10-20 years.
The long-term consequences of these therapies have yet to be determined and critical animal tests that could have provided safety and toxicology insights have not been run. Is the requirement for an experimental therapy a reasonable imposition, when the SARs-Cov-2 infection fatality rate is now at 0.15% and falling? The survivability of this virus, when you have symptoms, is 99.97% for those 65 and younger. Is the UW ready to take on the legal, moral and financial responsibility for the lives affected by these COVID19 therapies? Is the Board of Regents willing to take on that responsibility?
3. Your email stated: “In order to protect the health and safety of our students, faculty, academic personnel, staff and broader community, the University of Washington will require all students to be vaccinated against COVID-19.”
The imposed requirement of taking an experimental therapy runs counter to the spirit and letter of the law. Although the EUA program and the PreP ACT ( PreP ACT https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures) provide liability protection for the manufacturers of these COVID19 therapies and the administrators of programs under the EUA, the issues surrounding the essential requirement under the Nuremberg Code and the Helsinki Protocols, a well as Federal law for Informed Consent, make it a requirement to “seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”
The Common Federal Policy for the Protection of Human Subjects (“Common Rule”) [10 CFR 745] Sec 745.103(b)(3), none of these rights were revoked by any subsequent legislation, including [21 CFR 50.24], which allows the relaxation of requirements for informed consent during emergencies. In fact the Common Rule re-asserted safeguards both for informed consent, and for special protections against coercion: §46.116 General requirements for informed consent.
4. Your email stated: “Before the start of autumn quarter, students will need to verify they have been vaccinated unless they are claiming a medical, religious or philosophical exemption. This is similar to our existing tri-campus immunization requirement. If students are unable to verify they are vaccinated because they can’t get vaccinated where they currently live, the University will provide access to vaccinations upon arrival on campus. Early this summer, we will share how students can verify their COVID-19 vaccination or claim an exemption.”
The language of requirement and the lack of transparency as to the rights of students can only be viewed as coercive or exerting undue influence, in direct violation of Federal law and international agreements. The only remedy for this policy and language would be to explicitly state that these are experimental therapies that are not cleared for market by the FDA and students are not required to take them, but the University of Washington can only recommend that they be taken. Otherwise, the UW, the President of the UW and the Board of Regents could be found liable for not undertaking full due diligence in review of this requirement. The issue of Crimes Against Humanity for coercing or providing undue influence in medical testing of a drug or therapy are now being pursued by international legal scholars in Canada, the United States and Germany against those national governments.
I cannot state it more clearly: The COVID19 therapies or vaccines may be under EUA program approval, but they are not FDA cleared for market and are still undergoing clinical trials. The recent spike in COVID19 deaths in Washington state, after the roll out of the vaccine, suggests that some of those deaths could be due to vaccine related complications. This is only a working hypothesis, but the timing with the unprecedented spike in deaths should raise suspicion and warrant a re-assessment of the EUA program. Emerging data from Yale Epidemiologist Harvey Risch, MD, PhD (a past post-doctoral fellow from School of Public Health and Community Medicine, University of Washington (1983)) estimates that up to 40-60% of new COVID19 cases are from people that have been vaccinated (i.e. – breakthrough cases).
I have asked the Secretary of Health, Dr. Shah, to halt the EUA programs here in WA state, due to compelling evidence of injury and death brought about by these COVID19 therapies in the United States and to restrain the Land-Grant Universities from imposing a vaccination requirement with the experimental COVID19 therapies. I urge the President of the University of Washington and the Board of Regent to not require student to take these experimental therapies. A requirement for vaccination must come with a real-world assessment for the risk/benefit to the person being provided with the vaccine, as well as the respect for bodily autonomy and informed consent. This is policy driven by large gaps in information and policy devoid of solid evidence rarely turns out well.
Xavier A. Figueroa, Ph.D
Program in Neurobiology & Behavior
Department of Environmental Health and Toxicology
School of Public Health
University of Washington in Seattle