“Stay of Action” Filed Against FDA to STOP Approval of COVID Vaccine for Using Faulty PCR Tests in Trials
by Brian Shilhavy
Editor, Health Impact News
An ADMINISTRATIVE STAY OF ACTION has been filed with the Department of Health and Human Services and Food and Drug Administration (FDA) for the new Pfizer COVID vaccine that has been submitted for “emergency use authorization” (EUA).
It is widely expected that the FDA is going to grant EUA fast-track approval to Pfizer’s experimental COVID vaccine within days.
The STAY OF ACTION is a Petition for Administrative Action Regarding Confirmation of Efficacy End Points of Phase III Clinical Trials of COVID19 Vaccines.
The STAY OF ACTION is based upon the faulty PCR tests that were used in the vaccine trials:
Before an EUA or unrestricted license is issued for the Pfizer vaccine, or for other vaccines for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to false positives.
The Petitioner of this ADMINISTRATIVE STAY OF ACTION is Dr. Sin Hang Lee, a pathologist and founder of Milford Molecular Diagnostics, a CLIA-certified diagnostic laboratory in Milford, Connecticut.
Dr. Lee is a world-renowned expert on DNA sequencing-based diagnostics. He has trained and taught in some of the world’s most prestigious institutions and has published scores of scientific articles in peer-reviewed journals.
He recognized very early on that the PCR tests and other tests fast-tracked by the FDA were not accurate in identifying SARSCoV-2 RNA, and even sent a letter, back in March, to Dr. Margaret Harris and Dr. Eduardo Guerrero of the World Health Organization, and Dr. Anthony Fauci at the National Institute of Allergies and Infectious Diseases of the National Institutes of Health (NIH), explaining why the tests to detect SARS-CoV-2 RNA were generating false positives and negatives.
You can read his March 22, 2020 letter here. He explained that a two-phased test would “guarantee no-false positive results” based on his research and published work from Japan.
According to Attorney Mary Holland of Children’s Health Defense, he never received a reply from the WHO or the NIH. To this day, they continue to use faulty tests to identify COVID.
So here we are now at the end of November, 2020, and the FDA appears to be ready to grant EUA fast-track approval to COVID vaccines that have gone through Phase I, II, and III vaccine trials, all using these faulty COVID tests.
In Dr. Lee’s ADMINISTRATIVE STAY OF ACTION, he recognizes the great risk for harm on the American public if the vaccine trials are approved based on these faulty tests.
Petitioner and the public will suffer irreparable harm if the actions requested herein are not granted, because once the FDA licenses this COVID-19 vaccine, both governments and employers may make this product mandatory (in general, or for airline or international travel) or may recommend it for widespread use.
If the assignment of cases and non-cases during the course of the trial is not accurate, the vaccine will not have been properly tested. If the vaccine is not properly tested, important public policy decisions regarding its use will be based on misleading evidence. The medical and economic consequences to the nation could hardly be higher.
The New York State Bar Association has already issued a report on COVID-19 recommending that, “a vaccine subject to scientific evidence of safety and efficacy be made widely available, and widely encouraged, and if the public health authorities conclude necessary, required…”
Thus, it is reasonable to suspect that COVID-19 vaccines, including the Pfizer vaccine, could become mandatory. Without the FDA assuring proper efficacy trials of the vaccine now, the Petitioner and the public may not have the opportunity to object to receiving the vaccine, which was approved based on currently deficient and unreliable clinical trial data.
How likely is it that HHS and the FDA will grant this stay and deal with the PCR testing deficiencies before issuing emergency use fast-track approval to the Pfizer vaccine?
Not very likely at all, unless the public puts pressure on them to be more transparent and deal with these testing deficiencies, that top scientists all around the world now are speaking out against. See:
“Pandemic is Over” – Former Pfizer Chief Science Officer Says “Second Wave” Faked On False-Positive COVID Tests
German Lawsuit Against “FactCheckers” Will Force Them To Prove Legitimacy of COVID Tests
Dr. Peter Marks is the head of the FDA’s Center for Biologics Evaluation and Research, and will be the main person to make the decision of whether or not to issue an EUA for the Pfizer COVID vaccine. He recently told the press that “Americans can expect a very open process” in their evaluation of the experimental vaccine. (Source.)
We need thousands if not tens of thousands of Americans to contact Dr. Peter Marks and let him know the public is watching, and that we want the FDA to consider Dr. Lee’s ADMINISTRATIVE STAY OF ACTION and respond to it.
Here is Dr. Marks’ public contact info:
Dr. Peter Marks – email: Peter.Marks@fda.hhs.gov – Phone: 240-402-8116
Here is FDA Director Dr. Stephen Hahn’s contact info:
Dr. Stephen Hahn – email: Stephen.Hahn@fda.hhs.gov – Phone (Main FDA #): 1-888-463-6332 – Twitter account: @SteveFDA
A Strong Warning to the U.S. Military about Operation Warp Speed
If you are a member of the military who will soon be called upon to participate in Operation Warp Speed and help distribute the new experimental COVID vaccine, be careful that you do not end up on the wrong side of history!
Just claiming to be “following orders” if massive deaths and injuries result from this experimental vaccine may not save you!
That is what many of the Nazi doctors in Germany who served under Hitler tried to claim, but during the Nuremberg trials, and specifically the “Doctors Trial” in 1946-1947, twenty of the twenty-three defendants were medical doctors, and were accused of having been involved in Nazi human experimentation and mass murder.
Of the 23 defendants, seven were acquitted and seven received death sentences; the remainder received prison sentences ranging from 10 years to life imprisonment.
What they did under German law, or maybe “emergency orders” during war time, was probably perfectly “legal” at the time, but after the Hitler regime was overthrown those who committed these “legal” actions that resulted in murder and crimes against humanity, were brought to justice after the war.
Dr. Peter Marks and Dr. Stephen Hahn would also do well to just not blindly excuse Dr. Lee’s ADMINISTRATIVE STAY OF ACTION, because Dr. Lee appears to have close ties to Attorney Mary Holland, currently the Counsel for Children’s Health Defense and former Professor of Law at NYU, and one of the nation’s top attorneys when it comes to vaccines.
Mary Holland works now for Attorney Robert F. Kennedy, Jr., who himself has become one the top attorneys in the world taking on Big Pharma.
He currently has 4 lawsuits filed against pharmaceutical giant Merck, for their approval of the HPV vaccine, Gardasil, which has destroyed the lives of so many young people due to being fast-tracked into the market.
The work of Dr. Sin Hang Lee and his DNA sequencing-based diagnostic testing on the HPV Gardasil vaccine found DNA fragments in the vaccine, something that Merck and the FDA had denied. See:
Fighting Academic Censorship on Gardasil Vaccine Research, Dr. Sin Hang Lee Challenges Medical and Scientific Community to Debate in Open Forum
His work in identifying these problems with the Gardasil vaccine led Japan to stop recommending the vaccine as part of their national vaccination program.
Here is a warning from a former Military Commander regarding current Commanders taking part of Operation Warp Speed, and the legal risks of doing so, published at Children’s Health Defense.
Former Officer Warns Military of Pitfalls Surrounding COVID Vaccine Mandate
Fast tracking the SARS-CoV-2 vaccine for a probable military mandate creates unparalleled dilemma for commanders who will face prodigious legal, medical, safety and ethical questions.
By Pam Long
Children’s Health Defense
As the former commanding officer of the Headquarters and Headquarters Detachment of the 36th Medical Evacuation Battalion, I recommend urgent caution for military commanders with orders to have all soldiers vaccinated with the experimental SARS-CoV-2 vaccine.
My concerns include the legality of a mandate, lack of treatment protocols and surveillance for adverse reactions, and a research-based risk assessment.
Legal challenges to a SARS-CoV-2 vaccine mandate
Under Emergency Use Authorization, state governments cannot mandate the SARS-CoV-2 vaccine in the civilian sector. A military mandate would require demonstration that the military sector had a compelling justification for a mandate. Healthy, young service members are not an at-risk group as they are not obese, not over the age of 65 and do not have comorbidities that cause complications from respiratory diseases.
The SARS-CoV-2 vaccine currently is not approved by the U.S. Food and Drug Administration (FDA). Even with a pending warp-speed FDA approval in the next month, the military, which still hasn’t rectified the failures, summarized here, of its Anthrax Vaccine Immunization Program (AVIP) isn’t in a position to implement a safe SARS-CoV-2 program. The Pfizer and Moderna SARS-CoV-2 vaccines, both of which use new mRNA technology, have much more potential for reactogenicity than the anthrax vaccine.
In short, federal courts have set precedent that mandating experimental vaccines in the military is illegal. As I wrote in a previous article:
“In 2008, the federal court affirmed that the FDA, [U.S. Department of Health and Human Services] HHS and [Department of Defense] DOD allowed an illegal AVIP program by mandating an experimental anthrax vaccine for military personnel that was not licensed for use against inhalation anthrax, nor approved for use by a presidential waiver.”
The illegal anthrax vaccine mandate caused adverse health outcomes in thousands of service members, triggered a retention crisis among pilots and imposed disciplinary actions under the Uniform Code of Military Justice against service members who refused an experimental and highly reactogenic vaccine.
All of these outcomes are likely to reoccur under a SARS-CoV-2 mandate. The HHS distribution plan will allow for millions of people to take the SARS-CoV-2 vaccine within a short period of time before any signals of adverse reactions are identified.
A military mandate would also have to demonstrate compelling reason to remove the right of service members to vaccine exemption by confirming with blood titers testing that they have antibody immunity.
Virologists at the La Jolla Institute of Immunology reported to the New York Times in November 2020 regarding coronavirus:
“Eight months after infection, most people who have recovered still have enough immune cells to fend off the virus and prevent illness, the new data show. A slow rate of decline in the short term suggests, happily, that these cells may persist in the body for a very, very long time to come.”
The researchers reported that natural immunity can last years.
Policy on treatment protocols and surveillance for adverse reactions
Commanders should reject any plan to mass vaccinate service members with the SARS-CoV-2 vaccine without an active surveillance policy in writing to review.
That policy should include a phased roll-out of the vaccine, a screening form for contraindications, vaccine exemptions (for medical contraindication, religious and personal belief accommodations, and those who are immune), education for service members on how to report adverse reactions to the Defense Medical Surveillance System, and training for medical providers on safe vaccine storage along with treatment protocols for adverse reactions.
The lack of established treatment protocols for immune backfiring known as Antibody Dependent Enhancement, when antibodies enhance uptake of the virus instead of neutralizing, should set off alarms for this entire mRNA vaccine program.
Review of the research-based risk assessment
Commanders should demand to see a research-based risk assessment from DOD on the SARS-CoV-2 vaccine. This risk assessment should be compared to the alternative “no vaccine mandate” course of action for a virus with a 99.9% survival rate.
Some of the hazards previously identified in mRNA animal research include liver damage in ferrets, enhanced respiratory disease in mice and ADE lung damage in monkeys. Furthermore, service members of child-producing ages, both male and female, should be informed that developmental and reproductive toxicity has not been established in this vaccine.
Since the U.S. has sidestepped identifying mitigating controls in animal trials for COVID vaccines, then the research implores that all humans should be screened for potential vaccine-induced autoimmunity, and health providers to be prepared for both excessive swelling and pathological clotting.
Safety precautions, as outlined in the study “mRNA Vaccines — a New Era in Vaccinology,” include:
“However, recent human trials have demonstrated moderate and in rare cases severe injection site or systemic reactions for different mRNA platforms. Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components.
A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity.
Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.
Another potential safety issue could derive from the presence of extracellular RNA during mRNA vaccination. Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to oedema. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.
Safety will therefore need continued evaluation as different mRNA modalities and delivery systems are utilized for the first time in humans and are tested in larger patient populations.”
Medical ethics require patients’ informed consent in treatment
Given that the SARS-CoV-2 vaccine is designed to reduce symptoms and not to prevent infection or transmission, the military lacks a compelling justification for a vaccine mandate for members who are not at risk of virus complications.
This virus does not pose the fatality risks of anthrax or smallpox biological weapons in 2001. There has not been an “imminent risk” established within the military regarding COVID19 over the past six months, during which time the virus has downgraded in virulence.
In accordance with medical ethics, the chain of command is required to give service members choice in medical treatment with well-established efficacy and demonstrated safety. In 2005, the Journal of Virology reported that hydroxychloroquine was a “potent” treatment for SARs coronavirus, in “Chloroquine Is a Potent Inhibitor of SARS Coronavirus Infection and Spread.”
Zinc was also established in 2010 to inhibit coronavirus and block replication of virus cells. Trace element zinc is revered as “Nature’s Gift to Fight Unprecedented Global Pandemic COVID-19” in 2020 research and is associated with reduced in-hospital mortality for COVID-19.
In conclusion, the fast tracking of the SARS-CoV-2 vaccine for a probable mandate in the military will result in an unparalleled dilemma for commanders, with prodigious legal, medical, safety and ethical considerations that will clash with the DOD decision makers who have historically favored pharmaceutical vaccine contracts over medical choices of individuals.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.
Pam Long is graduate of USMA at West Point and is an Army Veteran of the Medical Service Corps. She served as a medical intelligence officer for NATO Stabilization Forces.
Read the full article at Children’s Health Defense.
Here are the Contact Details again for the FDA to urge them to address the issues in Dr. Lee’s ADMINISTRATIVE STAY OF ACTION.
Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research – email: Peter.Marks@fda.hhs.gov – Phone: 240-402-8116
Dr. Stephen Hahn, Director of the FDA – email: Stephen.Hahn@fda.hhs.gov – Phone (Main FDA #): 1-888-463-6332 – Twitter account: @SteveFDA