Last month President Biden announced an initiative that he asserts will ‘stop’ the SARS Cov-2 virus. A scientifically implausible objective, his outline included a plan to require all private businesses with 100 or more employees to ensure their employees are fully vaccinated or require weekly testing. The mandates are curious because they burden businesses in unprecedented and legally nebulous ways.
Using a mechanism referred to as an Emergency Temporary Standard through the Occupational Safety and Health Administration (OSHA), the administration asserts mandating vaccines will stop the transmission of the virus. However, the vaccine was neither developed for, nor indicated to arrest transmission of the virus. According to the FDA website, the vaccine is intended to “…reduce severe illness, hospitalization and death.”
So why might the Administration be issuing mandates for a vaccine that cannot achieve their stated purpose of ‘stopping the virus”? Consider possible reasons by looking through the lens of liability.
Cross my heart and hope to die.
As business-minded leaders do in the face of government overreach, a response must be developed that helps create certainty for the business. To get there in this case, one must review the most fundamental aspect of a mandate… if the business requires the action as a condition of employment, the business owns the consequence of what happens as a result. Understanding the business of vaccine liability may help a business determine whether it is in its best interest to accept the premise of the Biden Administration mandate, or perhaps consider other strategies, including legal challenges.
An important element of the liability relating to vaccines is whether the individual receives the Emergency Use Authorized (EUA)-version of the vaccine, or the newly FDA-approved, branded-version known as Comirnaty. While there is no difference in the actual drug in the syringe, there are differences in the liability protection offered under EUA for those who manufacture, distribute or in some way deliver the vaccine, compared to the FDA-approved Comirnaty.
According to the Congressional Research Service, “…in order to encourage the expeditious development and deployment of medical countermeasures during a public health emergency, the Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines.”
In a declaration effective February 4, 2020, nearly six weeks before the U.S. lock-downs, the HHS Secretary invoked the PREP Act and declared Coronavirus Disease 2019 (Covid-19) to be a public health emergency warranting liability protections for covered countermeasures inclusive of the available vaccines. According to the current PREP ACT, the protection against liability reaches into 2025.
All state and local governments, medical providers and related manufacturers and distributors of modalities for treatment of Covid-19 were exempted from liability. So for anyone who receives the EUA- version of the vaccine, which as of this writing is still the only version available in the U.S., one has no recourse from a liability perspective, except in very specific and limited circumstances should one experience an adverse event or die. However, once FDA-approved and sold under the brand name Comirnaty, liability is handled differently. Comirnaty is currently only available in Israel.
Under normal circumstances, the National Vaccine Injury Compensation Program (VICP) provides compensation for injuries caused by most vaccines routinely administered in the U.S., such as childhood vaccines and non-pandemic seasonal influenza vaccines.
Enter mandated businesses. Once a vaccine is mandated by a private business, an entity not outlined and protected under the PREP Act, nor protected once a branded drug is available on the market, liability protection seemingly does not exist for businesses.
Looking beyond the PREP ACT, consider the long-term efficacy data currently available. Since vaccines have only been available for a relatively short time, long-term data is simply unknown. However, that doesn’t mean the potential adverse events are not a liability for which a mandated company must model and prepare.
Consider the language from the FDA’s website, pertaining to long-term efficacy of the FDA-approved Comirnaty regarding Myocarditis and Pericarditis.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech Covid-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Add to this, we now believe the SARS CoV-2 virus was modified in a Chinese lab and the liability issues are more nebulous. A recently exposed a 2018 grant proposal submitted by Peter Daszak of the Eco Health Alliance, to DARPA, the Pentagon’s research and development arm. The proposal sought funding to engineer a Furin Cleavage site (FCS) into a beta coronavirus. The FCS was intended to increase the virulence of the virus in humans. DARPA deemed it too dangerous and denied the grant.
A year later, in 2019, a beta coronavirus virus with a FCS shows up having potentially ‘leaked’ from a Wuhan lab at which Daszak was coincidently using National Institute of Health (NIH) funding to make gain-of-function modifications to beta family coronaviruses. A significant percentage of the spike protein from the original strain of SARS Cov-2 are in the vaccine now being mandated. What other enhancements were made to that virus and inadvertently stitched into the vaccine? The answers are presently unknown.
Companies must decide whether mandating the vaccine for their most valuable asset, their employees, is a sound business decision. Can businesses confidently assert that without a legal fight, they will not have some liability in the face of potential short and long-term health issues associated with the currently available vaccine?