COVID-19 Vaccination Approvals: A Legal and Bioethical Framework
This Bulletin is brought to you by AHLA’s Life Sciences Practice Group.
- February 14, 2022
- Brian Malkin , McDermott Will & Emery LLP
- Abigail Kagan , McDermott Will & Emery LLP
On February 24, 2022, the American Health Law Association (AHLA) will be hosting a webinar, “COVID-19 Vaccination Approvals: A Legal and Bioethical Framework.” The program will focus, among other things, on the U.S. Food and Drug Administration (FDA) vaccine approval process, how the practice of medicine permits off label uses for FDA-approved products (but not Emergency Use Authorizations (EUA)), the challenges of operating within the confines of an EUA, and other life sciences aspects of using pharmaceuticals to quell the COVID-19 pandemic. This paper provides a prelude synopsis of these topics.
In general, vaccines are biologically-derived products that mimic infectious bacteria or diseases to trigger an immune response but not the actual disease. Prior to the use of newer messenger RNA (mRNA)-type vaccines developed to trigger an immune response for COVID, most vaccines contained weakened or inactivated versions of bacteria or viruses to help the body identify and destroy the bacteria or virus when encountered.
Most vaccine development programs have been time-intensive, with research and development phases that encompassed first identifying a theory for the product, followed by preclinical laboratory work and with appropriate animal models, followed by three distinct clinical research phases in humans. Briefly, Phase I research is conducted in a small group (fewer than 100 human test subjects) to determine if the vaccine is safe and to learn whether it triggers an immune response, as expected. Phase II research is conducted in hundreds of human test subjects to learn more information about the vaccine’s safety, immunogenicity, immunization schedule, and dose size. Finally, Phase III is the large, pivotal clinical trial in tens of thousands of human test subjects to continue to measure the safety (to identify any side effects, including rare ones) and the effectiveness of the candidate vaccine. All of this research is then combined with other known information about the manufacture and quality controls for the candidate vaccine and presented to FDA in a biologics license application (BLA) to demonstrate the candidate vaccine is safe, pure, and potent. Typically, this process takes years with many starts and stops to optimize the vaccine, its manufacture, dosing, and delivery.
The COVID-19 pandemic forced the biotechnology community at large to rethink these timelines and invoke the use of EUAs, which may be utilized during a public health emergency if certain conditions are met. An EUA is an authorization under Section 564 of the Federal Food, Drug, and Cosmetic Act that amends various acts of Congress, including the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) as codified at 21 U.S.C. § 360bbb-3 to allow use of a medical intervention under an EUA without prior approval. FDA’s safety, purity, and potency standards are, in effect, reduced during an EUA to: (1) a reasonable belief the product “may be effective” as an emergency countermeasure; (2) known and potential benefits of an EUA outweigh the known and potential risks; and (3) there are no formally-approved alternatives available. PAHPRA, in turn, amended the Public Readiness and Emergency Preparedness (PREP) Act, along with the Coronavirus Aid, Relief, and Economic Security (CARES) Act, to expand covered countermeasures, extend liability immunity to covered EUA-type countermeasures under the CARES Act, and add additional categories of qualified persons to administer such countermeasures.
The COVID-19 pandemic has been and continues to be a historical event for vaccine development. In particular, it was the first time FDA granted EUAs for vaccines that had not previously received approval and was particularly new for mRNA-technology-derived vaccines. In addition, although using mRNA technology for pharmacotherapy has been researched for decades, mRNA vaccines were developed to combat COVID-19 in record time. For example, a normal six-month follow up study after an initial vaccine administration was shortened to two months under an EUA.
Unlike an FDA-approved vaccine, EUA-type vaccines may only be used under the conditions identified in the EUA. Put another way, the practice of medicine, which allows health care providers to prescribe products with at least one approved use, simply does not apply. In addition, liability protections under the PREP Act would cover uses permitted under an EUA under a pandemic situation like COVID but would not include uses outside the EUA. Furthermore, use of an EUA-only vaccine outside its authorized use, e.g., as a booster or in other patient populations, violates the Centers for Disease Control COVID-19 Vaccine Program Provider Agreement, impacting not only reimbursement but the ability to remain in the Program, as well as the possibility of sanctions.
Although the COVID-19 pandemic has felt interminable, FDA’s EUA and approval process for COVID-19 vaccines in the United States have been quite rapid. FDA’s first EUAs were issued for vaccines from Pfizer-BioNTech, Moderna, and Janssen (Johnson & Johnson) administered to adults, which was then expanded for use in children at progressively younger ages at lower doses. A similar plan would be expected for the boosters, which first only had EUAs for immunocompromised individuals and the elderly, then adults, and then children, again with adjusted doses.
Yet, despite the public health importance for vaccine distribution as a tool for quelling the pandemic, there have been continuing challenges to individuals, schools, employers, or governments either recommending or mandating vaccines or boosters.
In addition to the novel issues surrounding vaccine development, there have been a number of COVID-19-focused health and safety laws passed by state and federal governments, beginning as early as March 2020, but it was not until June 2021 that a uniform standard began to emerge with the Occupational Safety and Health Administration’s (OSHA) emergency temporary standard (ETS) applying COVID-19 safety measures to the health care industry. This “Healthcare ETS,” which imposed numerous requirements upon health care employers, stopped just short of requiring vaccinations. Nevertheless, the Healthcare ETS did permit some workplaces, including hospital ambulatory care and home health settings, to be exempt from its obligations if these workplaces could demonstrate, among other requirements, that all employees were fully vaccinated against COVID-19.
For a brief period, in November 2021, there were no fewer than five different national mandates for COVID-19 health and safety applicable to the United States work force: (1) one vaccine mandate for federal employees; (2) a similar, but separate, vaccine mandate for certain federal contractors; (3) a completely distinct vaccine mandate from the Centers for Medicare & Medicaid Services (CMS) for all staff, volunteers, and contractors in certain health care facilities; (4) OSHA’s Healthcare ETS; and (5) a second OSHA ETS imposing a “vaccinate-or-test” requirement upon all large employers, regardless of the industry.
And amid each new wave of COVID-19 vaccine mandates came an equally vocal opposition from state legislatures and governors seeking to protect their constituents’ medical freedom and privacy. For example, in Texas, Governor Greg Abbott issued Executive Orders 39 and 40, prohibiting government, government-funded, and private entities from imposing vaccination mandates upon their visitors, benefit recipients, or employees. Other states, like Florida, passed legislation (House Bill 1-B) that permits employers to impose employee vaccination mandates, but only if the employer provides employees with a number of exemptions. The Florida legislation imposes penalties up to $50,000 per occurrence for any violation. And Montana’s unique legislation (House Bill 702) prohibits discrimination based on vaccination status, which serves to preclude employers from establishing vaccination mandates in the same way that any anti-discrimination law prohibits policies that unfairly punish employees in other protected classes.
By January 2022, it became more apparent that the federal vaccine rules proposed thus far would be displaced by a patchwork of state and local mandates and prohibitions. OSHA’s Healthcare ETS expired at the end of December 2021, and OSHA chose to withdraw its “vaccinate-or-test” mandate for large employers. A federal court in Texas enjoined the government from enforcing its vaccine mandate upon federal employees. And the federal contractor vaccine mandate remains in purgatory, awaiting a judgment on the merits before the Eleventh Circuit, which is not expected before mid-April 2022.
The CMS vaccine mandate is now the only nationwide vaccine standard currently in effect, as of this writing. In withdrawing its “vaccinate-or-test” rule, however, OSHA clarified that it would be “prioritizing its resources to focus on finalizing a permanent COVID-19 Healthcare Standard.” This permanent COVID-19 Healthcare Standard could be in place as early as May 2022.
Please join us for the upcoming webinar to learn more and participate in the discussion. You can register at https://educate.americanhealthlaw.org/local/catalog/view/product.php?productid=629