To My State and Federal Government Representatives,
The current push to market the COVID-19 therapies as vaccines against SARs-Cov-2 by the various Representatives and Senators in Washington is troubling. Both therapies have no proven ability to prevent a disease and carry a high level of adverse health effects (including death). Approval by FDA, unlike Emergency Use Authorization (EUA), has a higher threshold for establishing efficacy, which has not been proven and has been bypassed via the EUA. The reports from VAERS and V-safe reporting systems, as well as global reporting systems and media are showing that COVID-19 therapy deaths (Moderna and Pfizer) are 120 times higher than flu-vaccine related deaths. This is only on the first dose of a clinical trial. Expected deaths for the second dose are higher. Adverse health events are also running several-fold higher than comparable flu-vaccine events.
The Moderna and Pfizer therapies cannot be legally classified as “vaccines” as there is no proof of immunity, only correlates. One of the main reasons that vaccine development requires years of clinical research is the need to establish that immunity takes place in a vaccinated population against strains in the wild. The invocation of an EUA does not alter the laws of physics, the realities of biology or the ethical codes of physicians and public health officers. The only effect an EUA provides is immunity from legal liability to the manufacturers.
The accelerated nature on which the development of these mRNA therapies has proceeded needs to be addressed. In the vaccine literature, development of a vaccine against SARs-Cov-1 showed unique pathologies, such as liver and pulmonary damage after vaccinated mice and ferrets were challenged with SARs-Cov-1. Pathogenic priming and Antibody Dependent Enhancement (ADE) are known, potential risk associated with SARs vaccines that have plagued development of corona virus and respiratory syncytial virus (RSV) vaccines. The use of mRNA technologies for immunity development is untested in a population and the few number of animal studies done with these two candidates leaves a great deal of room for future toxicities.
1. The FDA Emergency Use Authorization (Emergency Use Authorization of Medical Products and Related Authorities Guidance for Industry and Other Stakeholders, JANUARY 2017) has a strict set of guidelines for invoking the EUA clause. This activation depends on there being a clear and supported danger to the nation. There is considerable debate and mounting evidence that the declaration of an emergency was overstated and unsupported (Ohio [IN THE UNITED STATES DISTRICT COURT WESTERN DIVISION FOR THE NORTHERN DISTRICT OF OHIO, Case No. 3:20-cv-1948]; New Mexico [IN THE UNITED STATES DISTRICT COURT DISTRICT OF NEW MEXICO, Case No.: 1:20-cv-01331]).
2. CDC has repeatedly reported the survivability of this viral infection is 99.95% for people in the age range of 1-69 years. Survivability for those 70+ of age is in the ~95% range. Deaths from non-COVID-19 related conditions, stemming from the measures of the lockdowns are rapidly rising and will surpass the deaths from COVID-19 itself (S.H. Jacobson and J.A. Jokela, Non-COVID-19 excess deaths by age and gender in the United States during the first three months of the COVID-19 pandemic, Public Health 189 (2020) 101e103).
a. There is no public health or economic reason to continue with the mandates as proposed by Governor Inslee or to consider a mandate or requirement to take a vaccine against SARs-Cov-2 at a State or National level.
b. Published studies from around the world have established dependable, safe and effective measures to assist patients affected with SARs-Cov-2 to recover.
c. The initial epidemiological model by the Imperial College of London (under the Principal Investigator, Dr. Neil Ferguson) was used by both the WHO and the CDC as the basis to declare an epidemic. The model predicted 2.2 Million excess deaths in the United States, which have proven wildly inaccurate (by a factor of at least 10x), including the overwhelming of the hospital systems in the US and UK in May and April. These occurrences DID NOT happen.
d. Prior to SARs-Cov-2 being identified, WHO (2019) recommended AGAINST population wide lockdown, population wide mask mandates and travel restrictions. Public health evidence on these strategies as mitigation measures remain unproven in the real world. The only reason that the lockdown strategy was initially supported by the WHO was due to the unproven restrictions that the People’s Republic of China implemented on its citizens in the City of Wuhan and Hubei province. Claims by the PRC that this was an effective strategy of containment are not supported.
3. The CDC announced on 18 March 2020 (New ICD-10-CM code for the 2019 Novel Coronavirus (COVID-19), April 1, 2020) that a new ICD-10 code had taken effect:
a. On March 11, 2020 the Novel Coronavirus Disease, COVID-19, was declared a pandemic by the World Health Organization. On March 13, 2020 a national emergency was declared in the United States concerning the COVID-19 Outbreak.
i. Per the March 13 2020 News Letter: “Given these developments, and the urgent need to capture the reporting of this condition in our nation’s claims and surveillance data, the Centers for Disease Control (CDC), under the National Emergencies Act Section 201 and 301, is announcing a change in the effective date of new diagnosis code U07.1, COVID-19, from October 1, 2020 to April 1, 2020. This off-cycle update is unprecedented and is an exception to the code set updating process established under HIPAA.”
ii. CDC made changes to the Medical Examiners’ and Coroners’ Handbook on Death Registration and Fetal Death Recording (2003 Revision) in their 24 March 2020 NVSS COVID-19 Alert No.2. This altered the 17-year established precedents and procedures for coding cause of death (COD)only for SARs-Cov-2 positive or presumed positive cases, irrespective of having or not having COVID-19 symptoms.”
iii. Using the standards in the Medical Examiners’ Handbook (without adhering to the No2. Newsletter changes) for coding deaths during the declared National Emergency would have resulted in a 70-90% lower number of COVID-19 reported deaths (COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective, Science, Public Health Policy, and The Law, Volume 2:4-22, October 12, 2020).
4. The major method of detecting the presence of a SARs-Cov-2 viral fragments is focused on RT-PCR assays. The guidance provided by the WHO (which the CDC has recommended to follow) has set the cycle threshold (Ct > 35 for RT-PCR) levels that are known to produce false positives at a high rate (Jaffar et al, Clinical Infectious Diseases, https://doi.org/10.1093/cid/ciaa1491).
a. The WHO has issued a new guidance in December 2020 and January 2021 to reduce the Ct threshold (http://web.archive.org/web/20210121170101/https://www.who.int/news/item/14-12-2020-who-information-notice-for-ivd-users). This will reduce the positive rate reported by RT-PCR assays and will end the pandemic by technical alteration of the threshold. This was a pandemic generated by an emergency instituted test with no calibration or population validation.
b. The WA DOH does not collect or request Ct threshold levels of the SARs-Cov-2 RT-PCR tests that it reports as “cases”. The WA DOH relies on the individual labs to report the results as “positive” or “negative” SARs-Cov-2. There is no reported quality control check at the DOH level to ensure that the tests are withing an appropriate reporting range. This has led to over-reporting of COVID-19 cases and COVID-19 deaths and extending the emergency order in Washington state and in the rest of the United States.
c. Deaths from all cause mortality in the US for 2020 were ~7-10% higher than in the past two years, but all cause mortality for the past two years (2018 & 2019) was significantly lower than 2017, which was a high mortality year from flu. We had a larger pool of susceptible people that survived and a larger pool of susceptible people that died due to lower seasonal infections in the past two years.
d. Deaths from depression, alcoholism, suicide and domestic violence are side-products of lockdown measures, which are not easily labeled or identified with a PCR test. These will contribute significantly to the all-cause mortality and should not be labeled COVID-19 deaths. These deaths are due to policy decisions at the State and Federal level.
In summary, the continuation of the 2020-05 Emergency Declaration in Washington state for COVID-19 is not supported by the accumulating evidence in the public and private sectors of society. WHO and CDC are in the process of making guidance changes that will provide more accurate and dependable results in detecting SARS-Cov-2. These changes will show that the measures taken against this virus were unnecessary and damaging to the fabric of our society.
These changes will, by fact of process, reduce the detection of false positives and provide results that align with the reality of this SARs-Cov-2 viral spread. We now have an endemic virus in our population that like many influenza, rhino- and coronaviruses are manageable. The dangers of this virus have been overstated and we need to lift the restrictions and get back to living, working and engaging in our communities.
Mandating experimental therapies or promoting them via city, county, state and federal governments agencies or orders is not the function of these institutions. Providing verifiable, accurate and timely information is the essential role of the people in these institutions.
I respectfully request that you, as public and elected officials, discontinue promoting and advocating for unproven therapies. These are private companies engaged in accelerated clinical trials.
I respectfully request that you, as public and elected officials, deny the Governor’s 2020—05 order and deny the extension of the Emergency Orders. For my Federal elected officials, I respectfully request that you require the CDC to provide an explanation, based in facts and sound reasoning, as to why the CDC instituted changes to the cause-of-death (COD) reporting and why they did not institute a review process for validating the RT-PCR test used as a front-line detection strategy. For more than 9 months technical experts from around the world have been pointing out this problem.
I respectfully request that you, as public and elected officials, require a thorough review of how the WA DOH and the federal government failed in their duties and obligations to apply basic risk and damage mitigation assessments in their recommendations for this State and National lockdown. Never in the 19th and 20th century has there been a blanket lockdown of the heatlhy
Xavier A. Figueroa, Ph.D.
University of Washington, Class of 2003; Ph.D. Neurobiology and Behavior
University of California at Davis, Class of 1994; Bachelor of Science in Microbiology