Policy & Regulation News

HHS Expands Workforce Authorized to Administer COVID-19 Vaccines

The HHS guideline states that any physician, registered nurse, or practical nurse whose license expired within the past five years can administer COVID-19 vaccines.

COVID-19 Vaccines

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By Samantha McGrail

- HHS recently issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add categories of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines. 

The amendment authorizes any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense, or administer COVID-19 vaccines approved for use by the FDA.

Additionally, HHS requires any healthcare professional to complete CDC COVID-19 Vaccine Training. Providers who are not currently practicing or whose license or certification expired must provide an on-side observation period by a practicing healthcare professional.

“To respond to the nationwide public health emergency caused by COVID-19, the Biden Administration is broadening use of the PREP Act to expand the vaccination workforce quickly with additional qualified healthcare professionals,” HHS Acting Secretary Norris Cochran, said in the announcement. 

“As vaccine supply is made more widely available over the coming months, having additional vaccinators at the ready will help providers and state health departments meet the demand for vaccine and protect their communities more quickly,” Cochran continued. 

Expanding the size of COVID-19 vaccinators across state lines allows states and US territories to meet the demand for vaccines and protect communities. 

The PREP ACT allows the HHS Secretary to issue a declaration that provides immunity from liability for certain claims during a public health emergency. 

The claims include claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions; those determined by the Secretary to constitute a present or credible risk of a future public health emergency; and claims involving entities and individuals involved in the development, manufacturing, testing, distribution, administration, and use of such countermeasures, HHS says in a resource on the PREP Act. 

At the end of August, HHS issued an amendment to the PREP Act to expand access to life-saving childhood vaccines during the COVID-19 pandemic. 

Increased access to vaccines decreases the risk of vaccine-preventable disease outbreaks as children in the US return to daycare, preschool, and school. 

Two months later, the agency issued guidance authorizing qualifying technicians and state-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines, and COVID-19 tests. 

The guidance stated that pharmacy interns can administer FDA-authorized vaccines that have been recommended by the Advisory Committee on Immunization Practices (ACIP) to individuals aged between 3 and 18 years. 

HHS also required that the vaccine be ordered by the supervising qualified pharmacist, be FDA-authorized, and administered according to ACIP and its immunization schedule. 

In November, HHS partnered with large chain pharmacies and networks to boost access to COVID-19 vaccines across the US. 

The partnership program will cover nearly 60 percent of pharmacies across the 50 states, the District of Columbia, Puerto Rico, and the US Virgin Islands. The program will also focus specifically on underserved areas. 

The US government partnership, Operation Warp Speed (OWS), which facilitates the development, manufacturing, and distribution of COVID-19 countermeasures, will support this effort.

Notably, vaccines will be administered at the specified pharmacy locations at no cost to patients.

In December, the federal government issued its fourth amendment to the PREP Act to expand the use of telehealth platforms for diagnostic testing and other devices used during the COVID-19 pandemic.

Under the order, a healthcare provider can order or administer “covered countermeasures,” including diagnostic tests that have received FDA emergency use authorizations, for patients in other states. 

Providers include pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain COVID-19 tests or vaccines. 

Additionally, the order specifically targets a barrier to telehealth expansion including state and federal rules that prohibit providers from using telehealth to treat patients in other states.