For Immediate Release
Washington, DC, March 8, 2021
Contact: Michael Vacca, Christ Medicus Foundation: (248) 897-0599
UPDATED FEBRUARY 4, 2022
As Members of the Health Care Civil Rights Task Force, our respective organizations have been fielding an increasing number of inquiries relating to individuals being required to take the
COVID-19 vaccine. We offer this press release as a general response to this issue. We are not making any definitive pronouncement about the status of federal or state laws. Nor are we advocating that people take or not take the vaccine, but simply seeking to protect the rights of those who in good conscience choose not to be vaccinated. The following information provides current federal law with respect to mandating and administering vaccines:
Current COVID-19 Vaccines Are Experimental Medical Products. It is important to note that no vaccine has received FDA approval for COVID-19 but to date three vaccines have received FDA authorization for emergency use. Being approved under an Emergency Use Authorization (EUA) means the products are investigational and experimental only, their investigational studies have not been completed, and the vaccine would not otherwise have been approved at their stage of testing.[1]
Federal Law Prohibits Mandates For Experimental Medical Products. Federal law regulates experimental medical products that have only been authorized for emergency use, and explicitly states that individuals have the right to “refuse administration of the product.”[2]
UPDATE: On August 23, 2021, the FDA announced the approval of the Pfizer vaccine for the prevention of COVID-19 in persons 16 and older. The approved vaccine will be marketed as Comirnaty. On January 31, 2022, the FDA announced that it approved the Moderna vaccine for adults 18 and older. The approved Moderna vaccine will be marketed as Spikevax.
Federal Law Requires Disclosure For Experimental Vaccines. This federal code also compels those who administer experimental medical products, including COVID-19 vaccines under an EUA, to disclose “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown.”[3] UPDATE: On August 23, 2021, the FDA announced the approval of the Pfizer vaccine for the prevention of COVID-19 in persons 16 and older. The approved vaccine will be marketed as Comirnaty. On January 31, 2022, the FDA announced that it approved the Moderna vaccine for adults 18 and older. The approved Moderna vaccine will be marketed as Spikevax.
COVID-19 Vaccine Manufacturers Are Immune from Legal Liability. According to 42 U.S. Code § 300aa–22, “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”[4]
Employers Who Try To Mandate COVID-19 For Employees May Be Liable For Damages
Employers are not shielded from liability like pharmaceutical companies when it comes to vaccines. Although pharmaceutical companies are not liable (unless there is willful misconduct), the law does not shield employers or businesses and should they attempt to mandate vaccines, they may be liable for any resulting harm.
UPDATE: Effective January 26, 2022, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) withdrew its vaccination and testing mandate that applied to employees of companies with 100 or more employees pursuant to the U.S. Supreme Court’s holding in Biden v. Missouri. The Supreme Court did allow the vaccine mandate issued by the Centers For Medicare and Medicaid Services (CMS) to go into effect (Beccera v. Louisiana). All staff at CMS participating health care facilities are required to get a COVID vaccine. Some employees may be eligible for a religious or medical exemption.
If anyone is being mandated or pressured to vaccinate and is choosing not to vaccinate, you may contact the Health Care Civil Rights Task Force for assistance in understanding your rights at healthcarecivilrights@gmail.com.
Signatories:
- Terry McKeegan, Esq.
- Joseph Meaney, PhD., National Catholic Bioethics Center
- Alexandra Snyder, Esq., Life Legal Defense Foundation
- Bobby Schindler, Terri Schiavo Life & Hope Network
- Julie Grimstad, Healthcare Advocacy and Leadership Organization
- Anne O’Meara, Healthcare Advocacy and Leadership Organization
- Father James Bromwich, RN, M.Div., STL
- Deb O’Hara-Rusckowski, RN, MBA, MTS
- Michael Arthur Vacca, Esq., Christ Medicus Foundation
[1] See www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-Vaccines
[2] See 21 U.S. Code § 360bbb–3 ***********.law.cornell.edu/uscode/text/21/360bbb-3.
[3] See 21 U.S. Code § 360bbb–3 ***********.law.cornell.edu/uscode/text/21/360bbb-3.
[4] See ***********.newsweek.com/fact-check-are-pharmaceutical-companies-immune-covid-19-vaccine-lawsuits-1562793.