The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. Vaccines are biologics and, as such, are authorized by FDA as COVID-19 countermeasures under the emergency use law.  The PREP Act empowers the Department of Health and Human Services (HHS) to issue declarations that immunize covered entities and individuals from tort liabilities that could stem from the use of countermeasures such as coronavirus vaccines to combat disease and/or threats deemed to constitute a public health emergency. On January 28, 2021, HHS amended its Declaration under the PREP Act again in order to address the need to expand the group of COVID-19 vaccinators to increase access to COVID-19 vaccinations. The new (fifth) amendment expands the definition of Covered Persons entitled to immunity to add categories of qualified persons authorized to prescribe, dispense and administer COVID-19 vaccines, to:

  • health care providers licensed or certified in any state to prescribe, dispense and administer COVID-19 vaccines in any other state in the U.S.
  • physicians, registered nurses or practical nurses whose license or certification expired within five years to prescribe, dispense and administer COVID-19 vaccines in any state in the U.S., as long as the license or certification was active and in good standing prior to the date it went inactive.

Healthcare providers who are not currently practicing or whose license or certification is expired must also complete the CDC’s COVID-19 Vaccine Training and undergo an on-site observation period by a currently practicing health care professional to qualify for PREP Act immunity. If a healthcare provider is authorized under the new amended Declaration to administer covered countermeasures, including a COVID-19 vaccine, any other state law that might prohibit that person from doing so is preempted.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.