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PREP Act Immunity Coverage for COVID-19 Vaccine Administration

Posted Dec 23, 20202 min Read

Regulatory & Clinical
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On December 23, 2020, Governor Holcomb issued Executive Order 20-51, which enumerates which health care professionals are to be considered “covered persons” when administering an FDA-approved COVID-19 vaccine under the Public Readiness and Emergency Preparedness Act (PREP Act).  Under the PREP Act, those who are considered “covered persons” for a COVID-19 countermeasure, which includes the administration of a vaccine, are provided civil liability immunity protection for the carrying out of that COVID-19 countermeasure.  The civil liability immunity protection provided under the PREP Act does not extend to actions or omissions that constitute willful misconduct.

Under the Governor’s Executive Order, the following health care professionals are to be considered “covered persons” when administering an FDA-approved COVID-19 vaccine:

  • Physicians, advance practice registered nurses, registered nurses, licensed practical nurses, physician assistants, pharmacists, pharmacist interns (including students) who are acting under the direct supervision of a pharmacist or other authorized health care provider, pharmacy technicians who are under the direct supervision of a pharmacist, medical students while performing duties as an intern or a resident under the supervision of the staff of a hospital or in a program approved by a medical school, and nursing students under the supervision of their preceptor, as determined by the nursing school;
  • Paramedics, advanced emergency medical technicians, and emergency medical technicians who are authorized by the EMS Commission to administer intramuscular vaccinations when their agency is operating and offering a COVID-19 vaccination administration site;
  • Members of the Indiana National Guard who have been trained to administer intramuscular vaccinations at a location specified by a local public health agency or the Indiana Department of Health; and
  • Medical assistants when authorized by an employing physician to administer an FDA-approved COVID-19 vaccine and when performed at the direction and under the supervision of the employing physician or group of physicians.  For medical assistants employed by a licensed health care facility, the Executive Order suspends IC 25-22.5-1-2(a)(2) for the limited purpose of allowing medical assistants employed by such a facility and who have been trained to administer an intramuscular vaccine to administer an FDA-approved COVID-19 vaccine if performed at the direction and under the supervision of a physician, physician assistant, advanced practice registered nurse, or registered nurse.

Please note, this is guidance only and should not be considered legal advice.  We encourage facilities to discuss this matter with your legal counsel should any of your facility’s staff members be engaged in administering an FDA-approved COVID-19 vaccine.