Public Health Emergency - Leading a Nation Prepared
As more COVID-19 vaccine becomes available, the Biden Administration wants to provide states, tribes, and territories with the flexibility needed to expand their vaccination workforce to ensure that every adult in America who wants to be vaccinated can receive their vaccine as soon as possible. States, tribes, and territories are encouraged to further expand the categories of persons authorized to administer COVID-19 vaccines in their states, tribal areas, or territories, as authorized under the
Public Readiness and Emergency Preparedness (PREP) Act, to respond to the local needs and availability of potential vaccinators.More healthcare personnel may be needed to administer these life-saving vaccines. To address this potential need, the Acting Secretary of Health and Human Services issued the seventh amendment to the PREP Act declaration that expands the pool of qualified people who can be vaccinators. The seventh amendment expands categories of covered qualified persons authorized to give the vaccine to include current and retired traditional and non-traditional healthcare professionals and students in healthcare programs.Below are a list of frequently asked questions and answers related to this most recent amendment to the PREP Act. If you have questions not addressed by this document, please email
No; if the providers meet the requirements stated in the declaration, that is sufficient. States may choose to use the providers as vaccinators.
An institution in the PREP Act can be a state, locality, or private sector organization. If there is a vaccination program at a private pharmacy or healthcare institution, that is covered by the amendment.
The PHE.gov site provides clarity on where individuals can go to register. States are managing their own registration and vaccination centers, so providers need to register through them.
The PREP Act preempts state law; so, any state restriction on a profession listed in the declaration that would prevent them from serving as a vaccinator is preempted. However, a state is not required to use all the professionals listed in the declaration. By listing these professions in the declaration, the Acting Secretary is identifying the providers as covered by liability protection under the PREP act if a State chooses to use them as vaccinators. However, the State would be responsible for which of the categories of professions it uses as vaccinators within its jurisdiction. For example, a state could opt to use dentists but not veterinarians, though both are qualified persons covered under the PREP Act.
We are encouraging individuals who are interested in being vaccinators to join their local Medical Reserve Corps (MRC) program. Many of the volunteer management portals that states and territories have developed are linkages to their MRC. We are promoting the new PREP Act declaration amendment with our MRC community. Across the 50 states and territories, MRCs look uniquely different and are state and local assets. It is up to the states on how to use their vaccination workforce and MRCs.
The PREP Act preempts state and local law that effectively prevents vaccinators identified in the declaration as qualified from prescribing, dispensing or administering vaccines. Specifically, state licensing and scope of practice requirements that would not permit a healthcare professional listed in the declaration from vaccinating are preempted. Licensing or scope of practice requirements that do not effectively prevent the professional from vaccinating, such as additional or different training, are not preempted.
Vaccinations for children are not addressed in this amendment, but the Secretary can further amend the declaration at any time. When the vaccines are available for children, HHS will consider best practices and what modifications to the declaration may be needed.
Some professions were not included in this amendment as their scope of practice varies state by state in regard to capability or training to administer IM injections. Because of this, HHS defers to the states and territories to add other healthcare professionals as vaccinators of COVID-19 vaccines.
HHS is deferring to states, tribes, and territories as to how to document that providers fall within the declaration.
The declaration does not require states, tribes, or territories to recertify providers. HHS defers to the states, tribes, and territories as to how to document that providers meet the criteria of the declaration.
If a program or institution has not engaged their students in the vaccinator process, HHS encourages students who are interesting in being vaccinators to join their local MRC or register with their state volunteer management organizations responding to COVID-19. HHS is promoting the new PREP Act declaration amendment with our MRC community; however, states and territories are empowered to determine how to use their vaccination workforce and MRCs.
The requirement for the CDC training is specific to professions added to the list of qualified persons under the seventh amendment. It is aimed at groups who may not administer intramuscular (IM) injections or vaccines as a routine part of their practice, who have retired, or are students. Thus, physicians who routinely prescribe, dispense, and administer vaccines under their license would not need to stop vaccinating and take the CDC training, nor would non-traditional providers who are already authorized by their state and who received state training. However, if a state, tribe, or territory chooses to use providers listed in the seventh amendment using the PREP Act declaration as the authority for these providers, the CDC training is required.
The seventh PREP Act amendment indicates that states, tribes, and territories may add training requirements.
HHS defers to the states, tribes, and territories to determine the best method for documenting compliance with requirements stated in the declaration.
In case of an adverse event, HHS wants to ensure that staff who are CPR trained are available. Because of the variety of venues, from mass vaccination clinics to small operations, vaccinators need to have the requisite skills to deal with any adverse events immediately. The intent is to avoid any possible delay in care due to a centralized, but physically distant CPR trained individual or group, time required to call for assistance, or in the unlikely event of simultaneous medical emergencies or adverse events.
This requirement is satisfied by, among other things, a certification in basic CPR by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education, or the Accreditation Council for Continuing Medical Education. The PREP Act declaration only requires basic CPR and not the other associated trainings. It also does not specify in-person or virtual, so this determination is at the discretion of the professional and the organization or agency the individual will be working under in their vaccinator role. Since there is no uniform CPR training required of all states, the decision is left up to the jurisdiction where the individual will be performing their duties. If the individual meets the requirement within the PREP Act and that of the requirement of the state where they are performing the vaccinator duties, they are covered.
HHS does not maintain a list of CPR training providers.
The PREP Act declaration does not specify whether the CPR training must be in-person or virtual, so this determination is at the discretion of the professional and the organization or agency the individual will be working under in their vaccinator role.
The declaration allows schools to determine the appropriate level of training for students.
The declaration does not address supervisory requirements of one specific licensed profession over another. Newly covered healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering IM injections, and for whom administering IM injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student. Supervision for covered students should be provided by a currently practicing healthcare professional experienced in administering IM injections.
HHS defers to states, tribes, and territories regarding maintenance of documentation.
Yes, if an individual is licensed to provide IM injections within the current scope of practice, this qualifies as “experienced.”
Newly covered healthcare professionals and students must have documentation of completion of the CDC COVID–19 Vaccine Training Modules and, if applicable, such additional training as may be required by the state, territory, locality, or tribal area in which they are prescribing, dispensing, or administering COVID–19 vaccines. The declaration allows schools to determine the appropriate level of training for students. Newly covered healthcare professionals and students must also have documentation of an observation period by a currently practicing healthcare professional experienced in administering IM injections, and for whom administering IM injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student. Pharmacist training requirements were established in the third PREP Act amendment that authorized pharmacists to prescribe, dispense, and administer both COVID-19 vaccines and Childhood vaccines. Training requirements for pharmacists are specific to the practice of pharmacy to support that broader authorization. (See
Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID–19 Vaccines and Immunity under the PREP Act; Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID–19 Vaccines, and COVID–19 Testing).
The PREP Act and the Secretary’s declaration preempt state licensing requirements that would effectively prohibit a provider authorized under the Declaration from prescribing, dispensing, or administering vaccines. Actions by a state licensing board to prevent a provider who is authorized under the PREP Act from prescribing, dispensing or administering vaccines or to bring a disciplinary action against a provider for acting outside the scope of their license or scope of practice, or a disciplinary action against the provider for acting without a license would be preempted if the provider meets the requirements of the PREP Act declaration. However, administrative actions to ensure that the provider holds or held a license in good standing would not be precluded. The PREP Act declaration specifies that current or former licenses must be in good standing. A provider who is not in good standing falls outside the PREP Act declaration requirements and could be disciplined by their professional board.
A willful misconduct claim may only be determined by the U.S. District Court in the District of Columbia.The willful misconduct standard is provided in the PREP Act statute to establish a very high level of liability protection for anyone who is authorized under a declaration. The statute identifies willful misconduct as a very high standard, beyond any level of negligence or recklessness, as acting intentionally to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk that is great as to make it highly probable that the harm will outweigh the benefit. In other words, intentionally and knowingly taking actions that are going to cause more harm than good. In addition, the PREP Act provides detailed procedural requirements for filing a willful misconduct claim in court. The determination of willful misconduct must be made by the federal US District Court for the District of Columbia. An individual who is injured would have to file a case before this Court to claim that willful misconduct has occurred.
Telehealth services related to prescribing, dispensing, or administering COVID-19 tests, drugs, and vaccines identified as covered countermeasures in the declaration would be covered.
Expansion of the distribution network will be something that the COVID-19 Vaccine Task Force and the White House COVID-19 Task Force will need to consider and deliberate on.
More information on the PREP Act declaration and expansion of the vaccinator workforce can be found at
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