COVID-19: Emergency Use Authorization

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  • Source: UncoverDC
  • 09/19/2023

The ongoing and unprecedented drive to protect humanity from SARS-CoV-2 using one of the experimental COVID-19 "vaccines" is made possible because of Emergency Use Authorization (EUA). The action allows the Food and Drug Administration (FDA) to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety. A handful of crucial events led to the enactment of the FDA's emergency powers, illustrating "how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis."

History Leading Up To EUA

Outlining the pre-history of EUA are the Thalidomide disaster in the 1950s; the "swine flu" epidemic in 1976; the AIDS crisis in the late 1980s; and the events of September 11, 2001. Tragically, the decade following the introduction of thalidomide revealed severe birth defects in the tens of thousands, with the catastrophe highlighting the importance of stringent standards of clinical review before the approval of new food and drug products.

The swine flu incident followed, which was ultimately defined as a policymaking disaster with serious health consequences (more on that below). Next, as an early precursor to EUA, the AIDS crisis introduced "DDI," an investigational drug that was not yet known to be safe and effective. At the time, some argued that the risks of breaking protocol by issuing a new drug paled in comparison to the number of lives it could save. Advocating for experimental testing of the drug was Dr. Anthony Fauci, as described in Harvard's Bill of Health:

"Impatient with FDA regulators' conservative approach, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, proposed a new "parallel track" system to administer DDI to eligible patients while continuing to study the drug. Other measures for circumventing FDA's formal approval process already existed at the time, but this proposal attracted the attention of President George H.W. Bush, whose support encouraged FDA to adopt the process and administer DDI to those in need."

After 9/11, with the 2004 enactment of the Project Bioshield Act, the "War on Terror" solidified the EUA. The act ordered billions of dollars in appropriations to purchase vaccines in preparation for a bioterror attack, along with the stockpiling of emergency countermeasures. To act rapidly in an emergency, Congress allowed the FDA to authorize formally unapproved products for emergency use against a threat to public health and safety (subject to a declaration of emergency by HHS). The congressional record shows that Congress was focused explicitly on a bioterror threat—not on preparing for a naturally occurring pandemic.

Following its enactment, for sixteen years, the EUA was implemented very little. It was used most extensively in combating the H1N1 swine flu pandemic of 2009 "by authorizing medical equipment and existing influenza drugs." Bill of Health points out that, following an amendment allowing for preemptive EUAs, the emergency measure was also used to "authorize occasional countermeasures in anticipation of MERS, Ebola, Zika, and other epidemics, none of which ultimately materialized in the United States."

Leading Up to the Current EUAs Against COVID-19

On January 31, 2020, Alex M. Azar II, then-Secretary of Health and Human Services under President Trump, announced his determination that a public health emergency existed in the United States, declaring:

"As a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV), on this date and after consultation with public health officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby determine that a public health emergency exists and has existed since January 27, 2020, nationwide."

Azar's announcement came ten days after the CDC confirmed the first case of 2019 Novel Coronavirus (2019-nCoV) in the United States—in the state of Washington—in a patient who had recently returned from Wuhan, China. Describing the virus, the CDC press release added, "While originally thought to be spreading from animal-to-person, there are growing indications that limited person-to-person spread is happening. It’s unclear how easily this virus is spreading between people."

To date, "Continued Consequences of Coronavirus Disease 2019 (COVID-19) (formerly called 2019 Novel Coronavirus (2019-nCoV)) Pandemic" has prompted DHHS to renew its public health emergency six times. The latest renewal occurred on July 19, 2021, under the leadership of current HHS Secretary Xavier Becerra. 

Emergency Use Authorization

Following the January 31st determination of a public health emergency (PHE), on February 4, 2020—and paving the way for Emergency Use Authorization (EUA) for COVID-19 vaccines—HHS Azar went a step further, determining that "there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19."

The Emergency Use Authorization Declaration, effective March 27, 2020, and published on April 1, further explains the circumstances justifying the authorization of emergency use (EUA) of drugs and biological products during the COVID-19 pandemic, "pursuant to section 564(b)(1)(C) the FD&C Act, (21 U.S.C. 360bbb-3(b)(1)(C)) subject to the terms of any authorization issued under that section. Based on the above-mentioned declaration and determination, the FDA may issue an EUA after determining the following statutory requirements are met:

  • The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020, EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition. 
  • Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may effectively prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2. 
  • The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product. 
  • There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. 

As reported by UncoverDC, a recent lawsuit filed by America's Frontline Doctors against DHHS Secretary Xavier Beccera and others alleges that tens of thousands of physicians have publicly attested to the numerous safe and effective alternative therapies for COVID-19, which are supported by over 300 studies, including randomized controlled studies. For example, observational studies in Delhi and Mexico City show impressive reductions in COVID-19 cases and deaths after mass distribution of Ivermectin. The lawsuit maintains:

“Inexplicably, the Defendants never formed or assigned a task force to research and review existing alternatives for preventing and treating COVID-19. Instead, the Defendants and others set about censoring both concerns about the Vaccines and information about safe and effective alternatives.” 

Still, in June 2020, following the EUA declaration, the FDA published industry guidance for the "Development and Licensure of Vaccines to Prevent COVID-19." The guidance is referenced in the FDA's most recent (May 2021) industry guidance for "Emergency Use Authorization for Vaccines to Prevent COVID-19."

A Closer Look at Moderna's EUA Fact Sheet for Healthcare Providers

The fact sheet, offered both by Moderna and the FDA and last updated June 24, 2021, describes COVID-19 as "predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea."

The 25-page document notes that since April 2021, there have been increased cases of myocarditis and pericarditis in both the Moderna and Pfizer mRNA vaccines, but not in the Johnson & Johnson jab. The sheet encourages women who are vaccinated with the Moderna vaccine during pregnancy to join a pregnancy registry "that monitors pregnancy outcomes in women exposed to Moderna COVID-19 Vaccine during pregnancy," adding that "available data on Moderna COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy."

The fact sheet, which points out "participants will be followed for efficacy and safety until 24 months after the second dose," cites  "clinical trial results and supporting data for EUA," explaining:

"The study allowed for the inclusion of participants with stable pre-existing medical conditions, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment, as well as participants with stable human immunodeficiency virus (HIV) infection. A total of 30,420 participants were randomized equally to receive 2 doses of the Moderna COVID-19 Vaccine or saline placebo 1 month apart."

A VAERS data search with the simple search criteria of "COVID-19 (COVID-19 VACCINE) along with "MODERNA," "PFIZER," and "JANSSEN" revealed 442,190 total events with at least one incidence reported—headache was number one with 86,325 reports. A quick summary of some of the more significant events are as follows (events reported/percent of 442,190):

    • CHEST PAIN: 12,206 / 2.76%
    • COVID-19: 9,944 / 2.41%
    • LOSS OF CONSCIOUSNESS: 7,916 / 1.79%
    • SARS-COV-2 TEST POSITIVE: 7,664 / 1.73%
    • DEATH: 4,690 / 1.06%
    • THROMBOSIS: 2,432 / 0.55%
    • DEEP VEIN THROMBOSIS: 1,574 / 0.36%
    • MYOCARDITIS: 1,314 / 0.30%

The Three "Vaccines" Currently In Use Under EUA

There are currently three experimental "vaccines" being offered in the U.S. under EUA. On December 11, 2020, the EUA for Pfizer and BioNTech's gene-therapy drug became active, and Moderna's followed seven days later on December 18. The Johnson & Johnson Janssen COVID-19 product received its EUA on February 27, 2021. In-depth information can be found via the links associated with each experimental "vaccine." While clinical trials for all three highly profitable drugs are currently ongoing, the FDA reports that the Center for Biologics Evaluation and Research (CBER) is monitoring the safety of authorized COVID-19 vaccines through both passive and active safety surveillance systems. The FDA's stated composition of each EUA drug are as follows:

The Pfizer-BioNTech COVID-19 Vaccine is a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection. The vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. The vaccine also includes the following ingredients:

lipids((4hydroxybutyl)azanediyl)bis(hexane-6,1-diyl) bis(2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

The Moderna COVID-19 Vaccine is a white to off-white, sterile, preservative-free frozen suspension for intramuscular injection. The vaccine contains a synthetic messenger ribonucleic acid (mRNA ) encoding the pre-fusion stabilized spike glycoprotein (S) of the SARS-CoV-2 virus. The vaccine also contains the following ingredients:

lipids (SM-102, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

The Janssen COVID-19 vaccine is a colorless to slightly yellow, clear to very opalescent sterile suspension for intramuscular injection. The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the SARS-CoV-2 spike (S) protein in a stabilized conformation. The vaccine also contains the following inactive ingredients:

citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate 80, sodium chloride. The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells in media containing amino acids and no animal-derived proteins.

The Wellcome Trust, under the leadership of Jeremy Farrar—one of the "experts" on Dr. Anthony Fauci's February 1, 2020 emergency teleconference—has put together an "explainer" of how COVID-19 vaccines have been made so "quickly and safely."

Past Failure of Rapid Vaccine Development

Research published in the Journal of the American Medical Association (JAMA) on May 26, 2020, titled Adverse Consequences of Rushing a SARS-CoV-2 Vaccine, Implications for Public Trust, emphasizes the consequences of ignoring the "vital evidence-based process of vaccine development and testing." The article references concerns in 1976 about the emergence of a new swine flu strain reminiscent of the lethal 1918 strain. President Gerald Ford convened a panel that recommended the nation's first-ever government-backed mass vaccination program. According to the study, the program failed miserably, stating:

"Poorly conceived, the attempt to vaccinate the U.S. population at breakneck speed failed in virtually every respect. Safety standards deteriorated as one manufacturer produced the incorrect strain. The vaccine tested poorly on children who, depending on the form of vaccine tested, either developed adverse reactions with high fevers and sore arms or did not mount an immune response at all. Reports emerged that the vaccine appeared to cause Guillain-Barré syndrome in a very small number of cases, a finding that remains controversial but added to the early momentum of the antivaccine movement. Once again, the pressure to rapidly distribute a vaccine undermined the scientific integrity of the process and damaged public trust."

In late March 1976, President Ford held a press conference to announce the government's plan to vaccinate "every man, woman, and child in the United States." On April 15, 1976, emergency legislation for the "National Swine Flu Immunization Program" was signed. Six months later, the media presented photos of high-profile celebrities and political figures receiving the flu jab. President Ford himself was even photographed in his office getting his shot from the White House doctor. As quoted in the September 30, 2013 edition of Discover Magazine:

"The Swine Flu Program was marred by a series of logistical problems ranging from the production of the wrong vaccine strain to a confrontation over liability protection to a temporal connection of the vaccine and a cluster of deaths among an elderly population in Pittsburgh. The most damning charge against the vaccination program was that the shots were correlated with an increase in the number of patients diagnosed with an obscure neurological disease known as Guillain–Barré syndrome."

Citing the intense uncertainty created by the current pandemic, the JAMA article points out the monstrous race that immediately got underway to develop a new vaccine for COVID-19 (as alternative treatment options were silenced), suggesting that failing to abide by safety and scientific rigor will fuel the argument that physicians and scientists can't be trusted. Taking a cue from the failures of 1976, the paper warns:

"COVID-19 has created intense concern and uncertainty in the US and throughout the world. There are immense public and political pressures to develop a new vaccine, a process that typically takes years, not months. But as history warns, these pressures must not supplant rigorous scientific practice. Proceeding stepwise through the phases of clinical trials is the ethical standard for investigations involving human research participants. Adherence to the scientific method is the only way to safeguard against a SARS-CoV-2 vaccine that is ineffective, or worse, carries unacceptable adverse effects."

Looking Beyond COVID-19

According to Harvard's Bill of Rights, there is virtually no precedent—whether written or historical—to direct the FDA's use of its relatively new power during "the greatest public health crisis the agency has ever faced." On the contrary, Harvard notes the history of EUAs exposes "essential dilemmas that aren't going away, and that will have to be grappled with in emergencies to come." adding:

"These issues cannot be resolved by looking to the law; they will inevitably require hard judgments about how to balance deference to scientific expertise with public accountability, how to integrate empirical analysis and value judgments, and how to weigh our competing values in times of crisis. The FDA's emergency powers underscore the impact these questions have on the public welfare—and demonstrate that the way we answer them can literally be a matter of life and death."

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