Client Alert: COVID-19 Vaccinations and Health Care Workers
By: Robert Braumuller, Esq., Zaina S. Khoury, Esq. and Nina Schuman-Bronson, Esq., MPH
This article appeared in the New York Law Journal on September 24, 2020.
On July 27, the Massachusetts-based biotechnology company, Moderna Inc. (“Moderna”), announced the commencement of the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19. Phase 3 clinical trial of investigational vaccine for COVID-19 begins, National Institutes of Health (Jul. 27, 2020), https://www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins. With Moderna as the regulatory sponsor and provider of the investigational vaccine for the trial, the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services’ (HHS) are providing funding for the trial. Id. This trial is the first of the vaccine efficacy trials to be implemented under “Operation Warp Speed”, which is a collaboration of multiple agencies led by HHS with the goal of fast-tracking the development, manufacturing and distribution of biologics, drugs, and devices for COVID-19. Id. There are approximately 30,000 adult volunteers expected to be enrolled in the study at U.S. clinical research sites. Id. As of September 8, 2020, the World Health Organization reports that there are 34 candidate vaccines in clinical evaluation and 145 candidate vaccines in preclinical evaluation. Draft landscape of COVID-19 candidate vaccines, World Health Organization (Sep. 8, 2020), https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.
Now, it is just a waiting game. The question some employers of health care facilities are contemplating is what happens when a vaccine is found to be safe and effective and released in the market? Will these employers require their employees to be vaccinated as a condition of employment? Are they legally allowed to do so? It is challenging enough to require employees to comply with influenza vaccination requirements. How will this bode for a vaccination for a novel virus?
Pursuant to 10 NYCRR § 2.59, healthcare facilities and agencies licensed under Article 28 or Article 36 of the Public Health Law and any hospice established pursuant to Article 40 of the Public Health Law must ensure that individuals employed or affiliated with such entities (whether paid or unpaid) who are not vaccinated against influenza wear a surgical or procedure mask while working in areas where patients or residents may be present when the Commissioner of Health determines that influenza is prevalent. New York State Sanitary Code, 10 N.Y.C.R.R. § 2.59(d). Such entities are not prohibited from adopting policies that are more stringent. New York State Sanitary Code, 10 N.Y.C.R.R. § 2.59(h). Some academic medical centers in Manhattan instituted policies requiring vaccinations as a condition of employment unless there was a valid exemption. It is a little different for medical practices because there are fewer requirements applicable to such entities as compared to licensed health facilities, such as hospitals. Accordingly, employees of medical practices have a stronger case to object to vaccination requirements as a condition of employment.
The U.S. Equal Employment Opportunity Commission (EEOC) updated its Pandemic Preparedness in the Workplace and the Americans with Disabilities Act guidance in March 2020 in response to the COVID-19 pandemic. Pandemic Preparedness in the Workplace and the Americans with Disabilities Act, U.S. Equal Employment Opportunity Commission (Mar. 21, 2020), https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act. The EEOC originally issued this guidance in 2009 (during the spread of H1N1 virus) but re-issued this to incorporate COVID-19 updates and clarified that there was no COVID-19 vaccine available as of its March 2020 update. Id. The guidance addresses the issue of whether an employer covered by the ADA and Title VII of the Civil Rights Act of 1964 can force its employees to get the influenza vaccine regardless of their medical conditions or religious beliefs during a pandemic. Id. The EEOC explains the following:
An employee may be entitled to an exemption from a mandatory vaccination requirement based on an ADA disability that prevents him from taking the influenza vaccine. This would be a reasonable accommodation barring undue hardship (significant difficulty or expense). Similarly, under Title VII of the Civil Rights Act of 1964, once an employer receives notice that an employee’s sincerely held religious belief, practice, or observance prevents him from taking the influenza vaccine, the employer must provide a reasonable accommodation unless it would pose an undue hardship as defined by Title VII (“more than de minimis cost” to the operation of the employer’s business, which is a lower standard than under the ADA). Id.
For further guidance on other workplace issues, please refer to the following issued by the EEOC: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, U.S. Equal Employment Opportunity Commission (Sep. 8, 2020), https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
In the past, the Occupational Safety and Health Administration (OSHA) explained that employers can require mandatory influenza vaccines for employees, however, employees who have underlying health issues and object to such requirement may be protected under §11(c) of the Occupational Safety and Health Act of 1970 (the “Act”) as this section prohibits retaliatory action against employees who exercise certain rights pursuant to the Act. OSHA’s position on mandatory flu shots for employees, Occupational Safety and Health Administration (Nov. 9, 2009), https://www.osha.gov/laws-regs/standardinterpretations/2009-11-09.
Given the tremendous loss of life and damage to the New York economy caused by the pandemic, legislators and agencies will likely push for mandatory vaccination for the COVID-19 virus. Many will resist mandatory vaccination once the COVID-19 vaccine is approved and enters the market.
We have seen mandatory vaccination pushback as recently as last year in New York, even when largely proven safe and effective. On June 13, 2019, due to public health concerns stemming from the measles outbreaks, the New York Legislature repealed the provision of its Public Health Law requiring children receive required vaccinations before attending school or day care (whether public or private), which allowed for a nonmedical, religious exemption, where parents or guardians “hold genuine and sincere religious beliefs which are contrary” to the requirement that the child receive vaccinations. NY CLS Pub Health § 2164.
More than 50 families challenged the legislation arguing that it violated constitutional guarantees to equal protection and free exercise. In viewing the overall history and context of the vaccination law, Supreme Court Justice Denise Hartman upheld the law noting “the inexorable conclusion that the repeal was driven by public health concerns, not religious animus.” F.F. v. State of N.Y., 2019 NY Slip Op 29376, ¶ 5, 66 Misc. 3d 467, 114 N.Y.S.3d 852, 863 (Sup. Ct.).
Would the same logic be applied to a potential mandatory COVID-19 vaccine? The COVID-19 vaccine will be novel and uncertain in its long-term effect. We will hear both sides of the argument—public health and the flouting of individual rights.
Proponents note several constitutional law cases including the 1905 U.S. Supreme Court decision in Jacobson v. Massachusetts to support the proposition that when individual interests are not powerful enough to outweigh the overall public benefit, constitutional challenges under the First Amendment have often failed.
Is this a compelling justification for states to exercise their police power to mandate COVID-19 vaccination? Employers who are exempt from the requirements of the ADA may want to protect their overall workforce regardless of individual objections to the vaccine.
With so much uncertainty in the coming months, we encourage you to reach out to Bleakley Platt & Schmidt, LLP for guidance and support to plan for these issues as they arise.