Monday, April 19, 2021

EUA Vaccines, Mandates and the US Military: Legal and Historical Issues/Meryl Nass

1.  Are Americans who receive vaccines under EUA experimental subjects?

·        Definitely yes.  An EUA product is not a law unto itself.  According to 21CFR Subchapter D Part 312:  "an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice."

·       FDA Commissioner Stephen Hahn told USA Today.

·        Medicines and vaccines are either licensed products or experimental products. There is no gray area between them in US law. Whether or not research is explicitly conducted, the use of experimental products (including those issued under an Emergency Use Authorization) falls under the Nuremberg Code and under US law regulating experimental drugs.  

·        Vaccines are drugs under FDA law:  "[V]accines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product," according to Marion Gruber, the current Director of FDA's Office of Vaccines Research and Review.

2.  US regulations (45 CFR 46 Subpart A) for the use of experimental products require: 

·        Neither of these requirements have been met for Covid-19 vaccines supplied to Americans by the US government, even for civilians. This suggests that the federal government may be trying to carve out a gray area in which the laws governing investigational products do not apply.

3.  US law (10 USC 1107) and Executive Order 13139, issued in 1999, although not the Nuremberg Code, permit the President of the United States to mandate the use of experimental drugs for military servicemembers "participating in particular military operations." Why did this law and EO come about?

·        Just prior to the first Gulf War, the FDA granted a waiver of informed consent to the Defense Department, enabling it to use experimental drugs without disclosure or consent and there was no adequate recordkeeping.  The result was Gulf War syndrome, a disabling condition that could not be clearly linked to particular drugs or exposures, and which occurred in 30% (200,000) of the returning soldiers.

·        Congress took this matter very seriously. Faced with the possibility that troops might encounter chemical, biological or radiological risks "during particular military operations," during which unlicensed drugs might be beneficial, Congress gave the Defense Department one method for their use.  This required the Secretary of Defense to formally request and receive from the President a waiver of informed consent, in writing, under EO 13139. Clearly, Congress' intention was to avoid frivolous use of this waiver.  Until now, it has never been used.

·        At the same time, Congress required the Defense Department to establish the Defense Medical Surveillance System, a force-wide database of all medical inpatient and outpatient encounters, all vaccinations administered, and all deployments and their dates, so that in the event of a future tragedy like Gulf War syndrome, there would be a clear record of the possible exposures soldiers had faced, and the diagnoses and treatments they had received.  Data from the Defense Medical Surveillance System were promised to be shared quarterly.  Instead, these data have been withheld from the general public since being provided to the Institute of Medicine in 2001, during its investigation into anthrax vaccine.

·        The language of 10 USC 1107 and EO13139 make clear that Congress' intention was to make drugs available to deployed troops on a particular military mission, for a narrow purpose.  The law's intention was not to mandate a vaccine or drug throughout the military force for the purpose of public health.  From USC 1107 "The Secretary of Defense may request the President to waive the prior consent requirement with respect to the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation." 

4.  What were the specific shortcomings in DOD's handling of investigational drugs during the Gulf War?  

·        The November 9, 1999 Subcommittee on National Security, Veterans Affairs and International Relations:  Testimony of William F. Raub, Deputy Assistant Secretary of DHHS for Science Policy, p 21, makes DOD's shortcomings clear, but also explains that the purpose of the waiver was to alleviate the infeasibility of providing informed consent in the middle of a military operation :

·        "In December 1990, motivated by concerns about potential chemical and biological threats to troops participating in Operation Desert Storm, the Department of Defense requested that FDA waive the informed consent requirement for use of particular investigational products. In response, FDA published an interim rule amending its informed consent regulations such that the Commissioner of Food and Drugs, given appropriate evidence, could determine that obtaining informed consent from military personnel for use of a specific investigational product would not be feasible in certain circumstances and to grant a waiver from the requirement for obtaining consent.  Shortly thereafter, the Commissioner approved waiver requests from DOD for use of pyridostigmine bromide tablets and botulinum toxoid vaccine. The aftermath of these decisions has been subject to intensive examination. The President's Advisory Committee on Gulf War Veterans ' Illness, deliberating during 1996 and 1997, described a number of shortcomings in DOD use of investigational products during the Persian Gulf war and recommended that FDA revisit the interim rule to address, among other thing , the adequacy of information disclosure to service personnel, recordkeeping and long-term follow-up of individuals who received investigational products..."

5.  While the Nuremberg Code is not officially part of the US Code, it is important to remember that it was formulated by American judges at the Nazi Doctors Trial.  It has subsequently been interpreted to have the force of law by US judges. According to the New England Journal of Medicine:

·       "[Nuremberg's] basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966).6,22 Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).23 ...Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations." 

6.  What information do we have regarding the safety, efficacy, necessity and manufacturing fidelity of the 3 Covid-19 vaccines currently authorized under EUAs and those expected to be authorized?

·        Safety:  2,216 deaths have been reported to a passive reporting system, VAERS, as of March 22.  CDC says it does not have a method for tracking deaths following vaccination, since most of its safety surveillance relies on vaccines administered within the healthcare system. According to MSN, "The struggle to find a way to complete the key vaccination mortality study highlights a growing frustration among officials working on the pandemic response that the federal government is still falling short in collecting, analyzing, and reporting of COVID-19 data." 

·        Yet CDC has assured the public that not a single death has been shown to be due to a vaccination. According to Elisabeth Rosenthal in the LA Times, "we still don't have a uniform national digital database that can track who is getting the vaccine." The bottom line is that we don't have the safety data we need, after over 100 million doses of unlicensed vaccines have been administered.

·      Meanwhile, the Astra-Zeneca vaccine has been found to cause serious, rare blood clots, especially in the brain, in perhaps one in 25,000 young recipients.

·        Data adequacy:  The Emergency Use Authorizations for the Covid-19 vaccines were issued with only a median of 2 months of data Only two months.  While the trials were originally expected to continue for 2 years, when vaccine became publicly available, the vaccine manufacturers offered vaccine to the subjects in their trials who had received placebos. Thus, the anticipated datasets from the clinical trials, in which placebo recipients would be compared to vaccine recipients in terms of long-term side effects and infection rates for 2 years, will be greatly abbreviated.  

  ·      According to Brownlee and Lenzer, "A decision [was] made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will." 

·        Efficacy:  We still do not know to what extent the vaccines are efficacious and to what extent they prevent transmission, both to current strains of Covid-19 and to newer variants.

·        Necessity:  On November 4, 2020, Stars and Stripes revealed that only one active duty servicemember had died as a result of Covid-19.  So had 8 reservists.  There were 59,000 Covid-19 cases documented in the military at that time.  In general, soldiers are young and healthy and unlikely to suffer severe illness or death.

·        Manufacturing fidelity:  The FDA is not required to inspect manufacturers of EUA products, as it is for licensed products.  Whether Good Manufacturing Practices are met is uncertain.  Emergent BioSolutions, which is the subcontractor for the production of the Johnson and Johnson, Astra-Zeneca and Novavax Covid-19 vaccines for the US market, continues to face delays receiving authorization from FDA for its J and J vaccine. This is the company that produces all US anthrax vaccine.  Furthermore, the DHHS Secretary has the authority to waive Good Manufacturing Practice (GMP) requirements for EUA products, and GMP waivers have been issued for other Covid-19 EUA products.

7.  What has the President said previously about Covid-19 vaccine mandates?

·        President Biden told reporters in December that he would not make Covid-19 vaccines mandatory.

8.  What if a soldier has a religious or philosophic objection to the vaccine?  For example, some Catholics were told to avoid the J and J vaccine.

·        From the experience with anthrax vaccine, I can assure you that servicemembers were not given vaccine exemptions for religious, personal belief, or often even valid medical reasons.  Suspected pregnancy, for example, was initially not permitted as a contraindication to vaccination.  That is why there were so many court martials and punishments for vaccine refusals.

9.  What benefits might be available for a soldier who is injured as a result of a Covid-19 vaccination?

·        Under PREPA, Covid vaccines have been designated as "covered countermeasures" by the DHHS Secretary, granting their manufacturers, distributors, healthcare workers and program planners a virtually complete waiver of liability. The single avenue to obtain benefits is the Countermeasures Injury Compensation Program, an administrative program of the DHHS. While benefits are potentially available only for lost wages and medical care, less than 10% of the injured who have applied to the program since it began 11 years ago have received any funds.  There is no court or special master; there is a one-year statute of limitations; and one must be able to prove that one's injury was caused by the vaccine.  The maximum benefit is about $370,000.  The average benefit paid has been about $200,000.  It is funded by Congressional appropriation.

10.  Soldiers do not understand why they lack the same rights as civilians

·        They remember many thousands of injuries caused by mandatory but unnecessary anthrax vaccines during the Gulf War, and subsequently.

·        They know how Federal District Court Judge Emmett Sullivan ruled in Doe v. Rumsfeld in 2004: "The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."

·        They have not forgotten over 100 Court Martials and hundreds or thousands of Article 15 punishments faced by servicemembers who refused dangerous anthrax vaccines.

·        They also know there may be other reasons for mandating vaccines in the military; for example, the former Army Surgeon General Sue Bailey, former DHHS Secretary Louis Sullivan, former General George Joulwan and former FDA Director of the Center for Biologics Kathryn Zoon are all currently on the Board of the anthrax vaccine manufacturer.

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