Position Statement: On the COVID-19 Vaccine

INTENT

The intent of this position statement is to emphasize that the New York State Nurses Association (NYSNA) supports the recommendation that everyone be vaccinated against SARS-CoV-2, the coronavirus that causes COVID-19 in a just, fair, and equitable manner so that those communities that experience the most risk of severe disease and death are prioritized for vaccine access. However, NYSNA does not support mandatory immunization as either a condition of employment or as a state or federal mandate. Vaccines play a vital role in public health and a safe and effective COVID-19 vaccine will, at a minimum, decrease the number of people experiencing severe effects of the virus and save countless lives. Nevertheless, the public has legitimate concerns regarding the safety, efficacy, and effectiveness of any vaccine that has been developed and processed under an Emergency Use Authorization (EUA), and one that particularly has been developed at “warp speed.”

POSITION

It is the position of the New York State Nurses Association that:

  • The federal government must uphold a key principle of medical practice to ‘do no harm’ and use the best available science to guide vaccine development;
  • The federal and state governments must uphold the key principles of justice and beneficence regarding distribution decisions of the COVID-19 vaccine to protect those who experience greater rates of disease and worse outcomes (socially vulnerable groups): older adults, people with underlying medical conditions, and people from disadvantaged racial and ethnic groups;
  • COVID-19 vaccination cannot be relied upon as an effective and sole intervention used for the prevention of COVID-19 transmission in healthcare settings;
  • The COVID-19 vaccine should be available free of charge with no out-of-pocket costs;
  • The federal and state governments must uphold the key principles of autonomy and informed consent and maintain an individual’s right to choose whether to be vaccinated with the COVID-19 vaccine;
  • Successful COVID-19 vaccination programs should include educational components that address the benefits, risks, and common misconceptions of vaccination;
  • Nurses and other healthcare workers have a right to know what risks they’re facing when they report to work. Hospitals must be transparent with workers and the public, reporting essential information such as how many COVID-positive patients they are treating, levels of PPE inventory, ongoing plans for screening and cohorting of patients, and the number of staff who’ve been exposed to or gotten sick from COVID-19;
  • NYSNA strongly opposes the mandatory vaccination of health care providers for COVID-19 as a condition of employment or as a state or federal mandate;
  • Patients, visitors and staff should be educated regarding COVID-19 vaccination facts and myths;
  • All controls needed to protect healthcare workers from SARS-CoV-2 exposure, including effective ventilation, appropriate and adequately-supplied PPE, AIIR (negative pressure) rooms, workplace accommodations for those at high risk of severe illness or death, etc., remain in place and are, where necessary, expanded upon to protect healthcare and other workers;

RECOMMENDATIONS

  • NYSNA calls for independent scientific reviews of all vaccine trial data at both the federal and state levels to assure those who wish to be vaccinated of the safety of all FDA approved COVID-19 vaccines.
  • NYSNA calls for complete transparency and distribution of the data and results from Governor Cuomo’s independent Clinical Advisory Task Force (comprised of leading scientists, doctors, and health experts) on the safety and effectiveness of the COVID-19 vaccines that will be distributed throughout New York State.
  • NYSNA calls for transparency and the distribution of the data and results of the COVID-19 efficacy, effectiveness, benefits, and risks from the incoming Biden administration’s independent scientific advisory board.
  • Vaccine distribution should be strictly applied based on principles of self-determination, autonomy, and beneficence.
  • Priority grouping of vaccine recipients should be strictly  applied based on principles of justice, without the ability of any individual to “jump the line” based on ability to pay or market-price bidding.
  • NYSNA calls for the development at both the federal and state levels of fact sheets that provide scientific information to dispel myths while providing the facts related to the benefits, risks, and side effects of each manufacturers COVID-19 vaccine.
  • NYSNA calls for the Secretary of HHS to expressly address, in the conditions of the COVID-19 EUA, that individuals can refuse the vaccine without suffering any reprisals or negative consequences.

Autonomy, Self-Determination, and Informed Consent vs. Public Health: Can an Employer Mandate a Vaccine Approved Under an Emergency Use Authorization (EUA)?

Under EAU Process

In the past, members of FDA and CDC have said that the answer is “no.” Imposing a mandate when there is still substantial uncertainty about the risk/benefit profile of a product authorized under an EUA would be onerous (Reiss, 2020). However, other interpretations of the law reveals that answer may not be so clear and that an individual’s right to refuse the vaccine would first require the Secretary of HHS to address the issue – but the EUA process does not clearly say the Secretary has to allow consequences-free refusal of the product.

Under Federal and State Law

Once again, the answer is not absolutely settled; however, most likely the answer is “no.” The U.S. Constitution and the Bill of Rights sets up a check and balance system where the federal and state governments would be strong enough and able to enforce order, but not so strong that it would violate the personal liberties of American citizens.

Federal agencies, such as the FDA, have avowed that individual rights of autonomy, self-determination, and informed consent will take priority over governmental mandates. The “FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on [its] website (emphasis added). (U.S. Food and Drug Administration, 2002 ; Kraus & Gruber, 2020).

Related Materials

References

Kraus, P.R., & Gruber, M.F. (November 5, 2020). “Emergency use authorization of COVID vaccines — Safety and efficacy follow-up considerations.” New England Journal of Medicine, 383:19, E101 – 103.

Reiss, D. (November 30, 2020). “Under an EUA, Can Businesses Require Employees and Customers to Get Vaccinated?” Harvard Law Bill of Health. Retrieved from https://blog.petrieflom.law.harvard.edu/2020/11/30/covid-vaccine-eua-mandate-business/.

U.S. Food and Drug Administration. (November 20, 2020). “Emergency Use Authorization for vaccines explained.” Retrieved from https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained?utm_medium=email&utm_source=govdelivery.

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