HHS Issues Guidance on Vaccine-related COVID-19 Countermeasures

The Department of Health and Human Services (HHS) recently issued Advisory Opinion 20-03 addressing vaccination-related issues and the Public Readiness and Emergency Preparedness (PREP) Act.

The opinion is significant because we are moving toward approval of COVID-19 vaccines over the upcoming months. In its opinion, HSS believes that the PREP Act preempts state law in three specified circumstances to the extent that state law may be more stringent than activities authorized by the HHS secretary under the PREP Act.

“Covered countermeasures” under the PREP Act are those that limit the harm from COVID-19, SARS-CoV-2, or a virus mutated from those viruses. Measures intended to prevent decreasing childhood vaccinations are deemed to be a covered countermeasure to make vaccinations more available during the pandemic.

To that end, HSS considers state-licensed pharmacists and pharmacy interns to be qualified persons under the PREP Act. Pharmacists or pharmacist interns who otherwise might not be eligible to administer such vaccinations, are permitted to do so under the PREP Act, provided that the pharmacist has undergone 20 hours of specified training. However, if a state permits such vaccinations with a lesser amount of training, the PREP Act does not preempt state law in that regard. The pharmacist in such a state can vaccinate and still have the PREP Act protection.

States that require a protocol or a collaborative practice agreement before a pharmacist can administer such vaccinations cannot prevent a pharmacist (otherwise qualified under the PERP Act) from administering Advisory Committee on Immunization Practices (ACIP) recommended vaccines to children ages three through 18.

Finally, the advisory opinion also addresses vaccination adverse reactions, and specifically acute respiratory or cardiovascular reactions or anaphylaxis. The CDC recommends epinephrine injections in that setting. The advisory opinion states that HSS considers epinephrine a covered countermeasure in such a setting, and can be administered by a pharmacist with “sufficient training.”

This opinion illustrates how broadly HSS believes the PERP Act should be interpreted. In the likely event of a change of administration, it will be interesting to see how a Biden-led HSS (and FDA for that matter) will assess and interpret the PREP Act protections and other immunities that were provided to defend ourselves against the COVID-19 pandemic.

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