Third Amendment to PREP Act Declaration Further Expands Scope of Liability Immunity for Medical Countermeasures Against COVID-19

To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10, 2020 Declaration, broadening the liability immunity protections afforded by the Public Readiness and Emergency Preparedness Act[1] (PREP Act). Specifically, the Third Amendment to the Declaration identifies an additional category of persons as “qualified persons” covered under the PREP Act: certain licensed pharmacists who order and administer, and pharmacy interns (who are acting under the supervision of a licensed pharmacist) who administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18.

In the first of our multi-part series on the PREP Act, we explained that the PREP Act authorizes the Secretary of HHS to issue a declaration that provides immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats, and conditions determined by the Secretary to constitute a present or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

To that end, on March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures deployed in the fight against COVID-19 (Declaration). On April 10th, the Secretary issued the First Amendment to the Declaration to extend liability immunity to covered countermeasures authorized under the newly passed CARES Act. And as we reported, the Secretary released the Second Amendment to the Declaration on June 4th for the purpose of clarifying that covered countermeasures include qualified countermeasures that limit the harm COVID-19 might otherwise cause.

The recently issued Third Amendment to the Declaration was prompted by a report from the CDC in which it found a significant decrease in rates of routine childhood vaccinations due to social distancing and other COVID-19 mitigation strategies, including “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits.” The CDC report concluded that the decrease in childhood vaccination rates is a public health threat and a collateral harm caused by COVID-19, and that rapidly expanded access to vaccinations is needed to respond to the pandemic. According to the Secretary, given the prevalence of community pharmacies across the country and their significant role in annual influenza vaccination, allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.

Therefore, notwithstanding any state or local scope-of-practice legal requirements, the Third Amendment identifies state-licensed pharmacists (and pharmacy interns acting under their supervision) as an additional category of qualified persons under the PREP Act when the pharmacist orders, and either the pharmacist or the supervised pharmacy intern administers, vaccines to individuals ages three through 18, so long as certain additional safety standards are satisfied (e.g., requisite training and licensure, compliance with the ACIP’s standard immunization schedule, and various recordkeeping and reporting obligations). The Third Amendment further clarifies the categories of diseases, health conditions, or threats that may have been caused by COVID-19––including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases––for which the Secretary recommends the administration or use of the covered countermeasures.

The Third Amendment is effective as of August 24, 2020, and all other sections of the Declaration remain in effect.

[1] See 42 U.S.C. § 247d-6d.