America’s Frontline Doctors files injunction against Covid Vax; Department of Justice Declares Vax Mandates are a Go
The Covid pandemic is built on data. Every action by our government in the name of public health relies upon it. Cited numbers of Covid infections and deaths justify everything from ever-fluctuating mask guidance, to how close we can stand next to each other, to how many people can sit in a restaurant, to whether our family and friends bump elbows with us, give us a hug, or wave from a distance. Data is driving what conditions our children will have when schools reopen (or choose not to). It drives whether we can be with our loved ones who are hospitalized or in nursing care.
Clearly the integrity of data about Covid-19 transmission and symptom severity should be of the highest importance to our elected officials. The people who represent us in government are creating or accepting policy that is changing the structure of our society, and shaping our future by affecting the mental and physical health of our children. Citizens are told to rely upon the data curated by our government to make decisions in our daily lives, including medical decisions.
Our current Administration relies on data for vaccine policy. President Biden is calling for citizens to go door-to-door to promote uptake of vaccines that are not approved by the FDA. And now, with the backing of the Department of Justice, the White House is encouraging businesses, government, schools, and health providers to deny services, access, and employment to those who are not vaccinated.
All of these actions and mandates rest on the foundation of Emergency Use Authorizations (EUA). i EUAs were codified in 2003, as part of the George W. Bush administration’s Project Bioshield, which sought to address anticipated bioterrorist attack threats. Over the next 17 years, EUAs were issued by the FDA dozens of times in response to threats like Anthrax, Ebola, Swine Flu, and Zika. ii
Since January, 2020, there has been a massive surge in EUA use. Over 600 EUAs paved the way for Covid drugs, tests, PPE, and medical devices. iii
Underlying all EUAs is the legal necessity for a declaration of emergency. Without that declaration, every subsequent action ceases to be legal.
There is No Emergency
In general, a drug or device will not go to market without FDA approval. EUAs bypass lengthy safety and efficacy studies, in the name of an urgent threat. The EUA provision of Project Bioshield anticipated novel biological threats, for which the benefit of swift drug development and access would outweigh the risk of rapid transmission of a biological agent.
Under the law, EUAs require only a declaration by the HHS Secretary of a public health emergency, or a significant potential thereof, which is a threat to national security. iv In 2020, HHS Secretary Alex Azar declared a state of emergency due to covid on January 31. It was renewed in April, July and October, and again January 2021. Our current Secretary Xavier Becerra renewed the public health emergency again in April and July, 2021. v
America’s Frontline Doctors (AFLDS) filed suit on July 19,2021 with the primary focus of stopping these declarations. The group aims to halt the use of covid vaccines under EUAs, namely Janssen, Moderna and Pfizer. AFLDS further wants to prevent FDA approval of the vaccines for children, for those who have already been infected with SARS-CoV-2, and any citizen unable to give “truly voluntary, informed consent.”
The suit is supported by robust statutory, legal and factual bases. Studies are presented that challenge the public health narrative and government asserted health and safety data for the novel vaccines. The suit asserts that there is no serious or life-threatening disease, that the vaccines are not effective, that vaccine risks outweigh benefits, there are available approved alternatives, and that health professionals and the general public do not have adequate information to allow for informed choice by individuals. The essence of the suit is, safety data that is crucial for informed consent has been obscured, manipulated, or omitted.
Whistleblower: 45,000 Deaths Caused by the Vaccine
One of the most striking revelations in the suit is an expert opinion that adverse events reported in VAERS are woefully deflated. As of the filing of the suit on July 19, 2021, the number of deaths reported to VAERS associated with covid vaccines was over 9,000. Whistleblower testimony by an expert in health data analytics estimated the number of deaths within 3 days of vaccination exceeds reports to VAERS by at least a factor of 5. Under oath, the Whistleblower made a conservative estimate of 45,000 deaths after vaccination.
The Biden Administration Is Treating Informed Consent as Expendable under EUAs.
We often hear that the covid vaccines are experimental, but what does that mean? In effect, it means the vaccine development process, which can take up to 15 years from research and discovery through four Phases of trials, has been expedited to less than a year.
The AFLDS suit points out, “The American public has not been properly informed of these dramatic departures from the standard testing process, and the risks they generate.”
A Fact Sheet accompanies each vaccine, which states effectively, it is your choice to receive or not receive the vaccine. “Should you decide not to receive it, it will not change your standard medical care.” The statement ends there and does not include any other areas of life that can be impacted by a refusal. It is upon this omission that DOJ advised the White House that the right to refusal does not “restrict public or private entities from insisting upon vaccination in any context,” and imposition of “secondary” or “nonmedical” consequences are not in violation of any law. The U.S. Constitution is notably missing from DOJ analysis of the issue.
According to the DOJ, “Although many entities’ vaccination requirements preserve an individual’s ultimate ‘option’ to refuse an EUA vaccine, they nevertheless impose sometimes-severe adverse consequences for exercising that option (such as not being able to enroll at a university” (emphasis added).
Beyond consequences for exercising the right to refuse medical intervention, however, DOJ further advises the White House that informed consent is expendable. In a Memorandum it asserts EUA law “directs only that potential vaccine recipients be ‘informed’ of certain information, including ‘the option to accept or refuse administration of the product.” The Memorandum continues, “Importantly, however, and consistent with FDA’s views, we also read [the EUA law] as giving FDA some discretion to modify or omit ‘the option to accept or refuse’ notification.” (emphasis added).
In justifying its position DOJ relies on statements made in 2003 Project Bioshield hearings, by Marc McClellan, former FDA Commissioner, and Dr. Anthony Fauci, then Director of NIAID, “explaining that the informed consent requirements contained in 21 U.S.C. §355(i)(4) do not apply to EUA products.” Dr. Fauci and Mr. McClellan put on Congressional record, “[U]rgent situations may require mass inoculations and/or drug treatments, such informed consent requirements may prove impossible to implement within the necessary time frame when trying to achieve the public health goal of protecting Americans from the imminent danger.” vi
The AFLDS lawsuit articulates well the dangers we face as Americans to our informed consent:
“The combined effect of (i) the suppression and censorship of information regarding the risks of the Vaccines, (ii) the failure to inform the public regarding the novel and experimental nature of the mRNA Vaccines, (iii) the suppression and censorship of information regarding alternative treatments, (iv) the failure to inform and properly educate the public that the Vaccines are not in fact “approved” by the FDA, (v) the failure to inform and properly educate the public that the DHHS Secretary has not determined that the Vaccines are “safe and effective” and on the contrary has merely determined that “it is reasonable to believe” that the Vaccines “may be effective” and that the benefits outweigh the risks, (vi) the sustained psychological manipulation of the public through official fear-based messaging regarding COVID-19, draconian countermeasures and a system of rewards and penalties, is to remove any possibility that Vaccine recipients are giving voluntary informed consent to the Vaccines. They have no real option to accept or refuse the Vaccines. They are unwitting, unwilling participants in a large scale, ongoing non-consensual human experiment.” vii
Where Do We Go From Here?
Despite clear Executive overreach and abuse of power with respect to Emergency Use Authorizations, the Constitution is still a beacon for those standing up for informed consent and human rights. Justice Alito recently wrote very encouraging words for Americans in a dissenting opinion in one of the first Covid-related cases to reach SCOTUS:
“[A] public health emergency does not give Governors and other public officials carte blanche to disregard the Constitution for as long as the medical problem persists. As more medical and scientific evidence becomes available, and as States have time to craft policies in light of that evidence, courts should expect policies that more carefully account for constitutional rights.” viii