Frequently Asked Questions

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 ASPRStakeholder@hhs.gov

State, Local, Territory, and Tribal Vaccination Efforts

Do states need to take any action for the professions listed in the latest amendment to the declaration to be able to administer the vaccines?

No; if the providers meet the requirements stated in the declaration, that is sufficient. States may choose to use the providers as vaccinators.

The amendment also includes "institutions" that are administering the vaccine. What is an institution in this regard?

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.

Do potential vaccinators need to register with the Department of Health and Human Services (HHS) or through their state registration system?

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.

Can a state restrict any of the professions listed in the PREP Act declaration from serving as a vaccinator? Additionally, does HHS expect each state to affirmatively include the professions listed in their vaccination team?

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.

How is the PREP Act declaration integrated with the Medical Reserve Corps (MRC) program?

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.

What is preemption and how does it work related to the PREP Act declaration?

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.

Once testing is completed and COVID-19 vaccines become available for and recommended for children, will this expansion of vaccinators be applicable for children? Would there be any special considerations for children?

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.

Categories of Qualified Persons

Why were some health care professions, such as basic EMTs, dental hygienists, and phlebotomists, not included in the expanded vaccinator pool?

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.

Is HHS actively encouraging states/state licensing boards to provide vaccination centers with credential verification of covered health care providers (both currently licensed and those with licenses that lapsed in the last five years) that meet the requirements outlined in the Declaration?

HHS is deferring to states, tribes, and territories as to how to document that providers fall within the declaration.

Previously Active Professionals

Do state licensing boards have to take any actions to reinstate practice authority to health care providers who have lapsed licenses with the last five years?

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.

Health Care Students

Where should health care students be directed to go sign up to become vaccinators in their state?

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.

Training and Supervision Requirements

Do all eligible providers need to complete the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training Modules in order to be eligible to administer the vaccine? Does the PREP Act Declaration’s requirement that all providers take the CDC COVID-19 Vaccine Training Modules apply to providers administering COVID-19 vaccines in a jurisdiction where they are licensed? Does it only apply to providers practicing in jurisdictions where they do not have licensure or practice authority under an interstate compact such as the Nurse Licensure Compact?

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.

Regarding the CDC COVID-19 Vaccine Training Modules, is there additional guidance available as to the meaning or implementation of “documentation” and “observation period” as the terms are utilized in the Declaration? What would be the minimal observation period and documentation requirement?

HHS defers to the states, tribes, and territories to determine the best method for documenting compliance with requirements stated in the declaration.

Why must all personnel administering the COVID-19 vaccine be skilled and qualified to perform CPR?

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.

There are many types of Cardio-Pulmonary Resuscitation (CPR) courses (CPR, CPR + basic first aid, CPR + AED, etc.). What type of CPR training satisfies the requirements?

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.

Does HHS have a list of suggested CPR training providers?

HHS does not maintain a list of CPR training providers.

Do I have to attend an in-person CPR training to meet the requirements of the PREP Act?

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.

For clarification, the Accreditation Council for Pharmacy Education (ACPE) accreditation standards for pharmacy programs indicate that all graduates must be properly trained for vaccine administration but doesn't technically approve those certification programs. Programs that are used by the schools, including the CDC recognized American Pharmacists Association (APhA) Pharmacy-Based Immunization Delivery certificate training program which many schools do use, satisfies the provisions of the amendment – correct?

The declaration allows schools to determine the appropriate level of training for students.

Can one health care professional provide supervision to another type of health care professional (i.e., can an RN supervise a pharmacy intern in a vaccination clinic)?

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.

Where is the documentation to be housed or presented as meeting requirements to participate?

HHS defers to states, tribes, and territories regarding maintenance of documentation.

Regarding supervisory requirements, if the supervisor can vaccinate as part of their license, is that the same criterion as being “experienced” in IM injections?

Yes, if an individual is licensed to provide IM injections within the current scope of practice, this qualifies as “experienced.”

What type of just in time training is required for people who don’t do IM injections? Why are pharmacists called out specifically for training? Why not leave that to the states?

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).

Disciplinary Action

If a patient is harmed in an incident involving the administration of a COVID-19 vaccine by a provider administering the vaccine outside of their jurisdiction of licensure, can a state licensing board in the state where the interaction happened take action to preclude the provider from further administering the vaccine there if it is not willful misconduct? Can a state licensing board where the provider is licensed take investigative or disciplinary action against a provider if a patient is harmed in the administration of a vaccine and it is not clear willful misconduct?

In the absence of state regulatory board involvement, who has the authority to deem to be classified as willful misconduct?

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

Does HHS plan to issue additional guidance explaining in more detail which telehealth services would qualify as covered countermeasures to COVID-19 under the Fourth Amendment to the PREP Act?

Telehealth services related to prescribing, dispensing, or administering COVID-19 tests, drugs, and vaccines identified as covered countermeasures in the declaration would be covered.

Other Expansion and More information

Given the recent expansion of approved COVID-19 vaccinators, will there be an expansion in the distribution network to those individuals?

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.