Vaccines in Development

Eligible Vaccinators

  • Pharmacists

    On September 3, 2020, the Office of the Assistant Secretary for Health (OASH) issued a Declaration under the PREP Act, authorizing State-licensed pharmacists to order and administer, and State-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, to persons ages three or older COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA). The authorization is subject to satisfaction of the requirements listed below: 

    • The vaccine must be FDA-authorized or FDA-licensed.
    • The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP’s) COVID-19 vaccine recommendation. 
    • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. 
    • The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. 
    • The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
    • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. 
    • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements related to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. 
    • The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. 
    • The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

    This authorization preempts any State and local law that prohibits or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above. But this authorization shall not preempt State and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons. 

    Read the full HHS guidance here

    An amendment was issued on January 28, 2021 stating: 
    Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under the section V(d) of this Declaration, who prescribes, dispenses, or administers COVID-19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID-19 vaccination effort by a federal, State, local Tribal or territorial authority or by an institution in the State in which the COVID-19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General, subject to: (i) documentation of completion of the Centers for Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID-19 vaccine(s) to be administered

  • Technicians and Interns

    On October 20, 2020, the Office of the Assistant Secretary for Health (OASH) issued a Declaration under the PREP Act, authorizing both qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist to administer FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages three or older and to administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages three through 18 according to ACIP’s standard immunization schedule. The authorization is subject to satisfaction of the requirements listed below: 

    • The vaccination must be ordered by the supervising qualified pharmacist.
    • The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
    • The vaccine must be FDA-authorized or FDA-licensed.
    • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).
    • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
    • The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
    • The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. 
    • The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s). 
    • The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system (vaccine registry).
    • The supervising qualified pharmacist is responsible for complying with requirements related to reporting adverse events. 
    • The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern. 
    • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. 
    • The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

    This authorization preempts any state and local law that prohibits or effectively prohibits those who satisfy these requirements from administering COVID-19 or routine childhood vaccines as set forth above. It does not preempt state and local laws that permit additional individuals to administer COVID-19 or routine childhood vaccines to additional persons. 

    Read the full HHS guidance here

Billing & Reimbursement

Report COVID-19 Vaccine Billing Issues Here

Use this tool to report issues you encounter with either medical benefit or prescription benefit claims. These reports will be monitored and aggregated to identify systematic issues being faced by pharmacies across the country. 

Training & Other Requirements

Education & Training

  • Pharmacy-Based Immunization Delivery Certificate Training Program
    • Click here to find out where this program is being offered in your state. 
    • This program meets the 20 hour training requirement from the PREP Act Authorization.
  • You Call the Shots - Continuing Education provided by CDC

Additional Requirements

Scheduling Tools

  • Comparison of various scheduling apps and web-based tools

Vaccine Safety

Vaccine Hesitancy & Other Communication Tools

Customizable PowerPoint Presentation on Vaccine Hesitancy
Click here to download a PowerPoint presentation prepared by CPESN for pharmacists to use to speak to audiences about COVID-19 Vaccine Hesitancy

Six ways to help build COVID-19 vaccine confidence

CDC Provider Resources for COVID-19 Vaccine Conversations with Patients

Myths & Facts about COVID-19 Vaccines

CDC Toolkit for Pharmacies - includes fact sheets, conversation starters, talking points, social media messages, posters and printable stickers

APhA Vaccine Hesitancy Resource

CDC Patient Education Resources

Reporting

Immunization Information Systems (IIS)

Immunization Information Systems (IIS), otherwise known as immunization registries, are state, city or territory-wide databases of patient vaccination records. Administered vaccines should be documented in your local IIS. 

VaccineFinder

VaccineFinder is a free, online resource for patients and partners to search for locations offering vaccine services. This tool is utilized by the CDC during pandemic emergencies to identify partners for allocating vaccine supply. Register your pharmacy today.


CDC - COVID-19 Vaccination Reporting Data Systems
CDC - COVID-19 Vaccination Program Provider Requirements and Support