Tuesday, June 29, 2021

The law on Emergency Use Authorized (EUA = experimental, investigational) products

* I wrote the following on March 29, 2021.  It is important for those fighting vaccine mandates under EUA to understand the legal background for EUAs. 

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.

EUA products are still considered investigational," 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.  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."  

4.  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.

5.  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.

6.  What benefits might be available for anyone 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.

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