| Covid-19 | Sep 15, 2020

Trump Administration Actions to Expand Access to COVID-19 Vaccines

HHS’ Office of the Assistant Secretary for Health (OASH) issued guidance under its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) intended to expand access to safe and effective COVID-19 vaccines when they are made available. This guidance authorizes state-licensed pharmacists to order and administer COVID-19 vaccinations; state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist may also administer COVID-19 vaccinations. Among other requirements outlined in the guidance, state-licensed pharmacists and pharmacy interns must ensure the following conditions are met:

– The vaccine must be FDA-authorized or FDA-licensed.

– The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.

– The licensed pharmacist and/or intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE).

– The pharmacist/pharmacy intern must comply with any applicable requirements set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

(Previously on August 19, HHS issued the third amendment to the Declaration under the PREP Act to authorize state-licensed pharmacists to order and administer any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to individuals ages three to 18 years according to ACIP’s standard immunization schedule. This amendment was intended to mitigate decreasing rates of routine childhood immunizations due to COVID-19, The order does not affect federal requirements regarding screening and enrollment of Medicare and Medicaid providers (42 CFR Part 455, subpart E).)