The Legal Framework for Administering COVID-19 Vaccines

December 17, 2020 | Maggie Davis

After a deadly year, a vaccine to prevent COVID-19 infections is finally here. Earlier this month, the FDA issued an Emergency Use Authorization (EUA) for a COVID-19 vaccine developed by Pfizer/BioNTech and will be considering a similar authorization for a vaccine developed by Moderna later this week.

Anticipating a rapid deployment of COVID-19 vaccines as they are authorized, the CDC developed COVID-19 Vaccination Program Operational Guidance in collaboration with state and local jurisdictions to outline how each jurisdiction will make an authorized vaccine widely available. In addition to the operational plans, there is a legal framework of federal and state laws supporting the distribution and administration of the FDA-authorized vaccines.

Generally, state and territorial legislatures establish the legal scope of practice for health professions. These state laws, while closely aligned with standards established through professional organizations, determine which health professionals are legally authorized to diagnose disease, prescribe medication, or administer certain procedures. Administration of the first doses of the FDA-authorized COVID-19 vaccines is relatively straightforward.

Healthcare personnel and long-term care facility staff and residents have been prioritized to receive the first doses. Because these two groups are connected with a healthcare facility, or partnered with a pharmacy authorized to prescribe and administer the vaccination, the issues discussed below may not be applicable. As the vaccination efforts expand beyond these groups, there are legal mechanisms to both widely prescribe the vaccine and establish which healthcare providers are authorized to administer the vaccine.

Who Has Authority to Vaccinate? It Depends on the State

The authority to prescribe medication usually rests with a state licensed physician, although in recent years many states have expanded some prescribing authority to state-licensed advanced practice registered nurses and state-licensed pharmacists. Typically, prescriptions are tailored to an individual patient that has been evaluated by a medical professional with prescribing authority. For vaccinations—which are most successful when widely available to the intended populations—the prescription authority is often granted through a standing order rather than an individual prescription.

A standing order is a set of protocols establishing what groups of people should receive a vaccine, how to determine the appropriate vaccine based on patient needs, specific procedures for administer the vaccine, documentation requirements, how to manage medical emergencies related to the vaccine administration, and reporting of possible adverse events following the vaccination. The CDC has created a model standing order for the Pfizer/BioNTech vaccine that the medical director of a healthcare facility may use.

During a public health emergency, each state has a legal mechanism for their chief medical officer to either issue a statewide standing order or facilitate an emergency vaccination program. Some states provide their state or territorial health official authority to issue a standing order during normal operations. For example, Indiana authorizes their state health commissioner to issue a standing order for immunizations recommended by CDC’s Advisory Committee on Immunization Practices (ACIP).

Other states, like Oregon and Iowa, provide their state health official the authority to issue a statewide standing order during a declared public health emergency. Similarly, states like Minnesota and Delaware have statutes outlining specific emergency vaccination efforts during a declared emergency. During the 2020 legislative session, New Hampshire amended its statute for treating or preventing communicable disease to allow physicians to issue standing orders for immunization and testing during a public health emergency.

Alternatively, the power for a state or territorial health official to issue a statewide standing order is provided by the governor’s emergency powers. For example, in Maryland the governor has the power to declare a catastrophic health emergency that would provide the health official the authority to issue a standing order to facilitate vaccination efforts. One of the primary reasons for a health official to issue a standing order for a COVID-19 vaccine is to establish which medical professionals are authorized to administer the vaccine.

For example, Missouri’s standing order to administer the Pfizer COVID-19 vaccine expanded the authorized groups by permitting medical students to administer the vaccine while working under a licensed physician. Alternatively, states like Maryland expanded the scope of practice for administering the COVID-19 vaccine through a health order rather than a standing order.

Changes from the Federal Government

In addition to scope of practice authority changes for issuing the vaccine, the federal government expanded pharmacist authority to administer COVID-19 vaccines nationwide. Prior to the pandemic, all 50 states and D.C permitted licensed pharmacists to administer at least one vaccine to adults, while only 28 permitted pharmacists to administer vaccines to children. Through a Public Readiness and Emergency Preparedness (PREP) Act Declaration on March 10, Health and Human Services Secretary Alex Azar effectively expanded the scope of practice for all pharmacists and pharmacy interns in relation to administering vaccinations.

The PREP Act provides liability protections to manufactures, distributors, program planners, and qualified persons involved in the COVID-19 vaccination efforts. Under the declaration, pharmacists and pharmacy interns are qualified persons under the declaration and are permitted to administer COVID-19 vaccinations that are authorized or licensed by the FDA, in accordance with the ACIP recommendations.

As the vaccination efforts continue, more states are anticipated to issue standing orders outlining which medical professionals are authorized to administer the vaccines across their state. Looking ahead, it is likely that state legislatures will consider expanding the scope of practice for more medical professionals to be authorized to administer vaccinations outside of a public health emergency. ASTHO will continue to monitor these legislative changes.