Under an amendment to the Public Readiness and Emergency Preparedness Act (PREP), pharmacists and pharmacy interns in the United States are now permitted to administer vaccines recommended by the Centers for Disease Control and Prevention (CDC) to children over three years of age.1
Currently, there are 28 states that allow pharmacists to administer vaccinations to children. In 22 states, there are laws that limit which vaccines pharmacists can administer, including three states that prohibit pharmacists from giving vaccines to any children.2
HHS Directive Expands Access to Childhood Vaccines
The new directive allowing pharmacists to administer vaccines to children over age three was declared Alex Azar, head of the U.S. Department of Health and Human Services (HHS), with the aim of increasing access to CDC recommended childhood vaccines to children returning to daycare, preschool and school after the COVID-19 lockdown that closed day care facilities and schools in most states.3
According to Secretary Azar, “The Trump Administration has worked to allow pharmacists — alongside all of America’s heroic healthcare workers — to practice at the top of their license, empowering the public with more options to protect their health and well-being.”4
The amendment authorizes state-licensed pharmacists, as well as pharmacy interns acting under their supervision, to administer vaccines to children over age three if the pharmacy intern is licensed or registered by his/her state board of pharmacy.5 The HHS authorization also allows state-licensed pharmacies to administer vaccines to the children without a doctor’s prescription.6
CDC Reports Decline in Childhood Vaccination Rates During Pandemic
A report released by the CDC in May 2020 showed that routines childhood vaccination rates had plummeted during the COVID-19 pandemic as a result of families staying at home. The CDC report states that orders for because of lockdowns and social distancing requirements keeping families at home. The numbers of childhood vaccines given in doctors’ offices plummeted in late March 2020 and early April 2020 as doctors offices were forced to close or saw fewer patients, raising concerns that vaccination rates would decline.7
Secretary Azar said that this declaration was signed to prevent vaccination rates from falling even further.8
HHS Authorization Subject to Requirements
The amendment authorizes state-licensed pharmacists and pharmacy interns to administer childhood vaccines but is subject to some requirements as listed below:9
- The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
- The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) vaccination schedules.
- 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).
- The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.
- 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, vaccination-related continuing pharmacy education during each state licensing period.
- The licensed pharmacist must comply with record keeping 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 vaccination information to the state or local immunization information system (vaccine registry), complying with requirements with respect 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 inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.10
American Academy of Pediatrics Opposes Vaccination of Children by Pharmacists
The HHS directive allowing all state-licensed pharmacists and pharmacy interns the ability to administer childhood vaccines is opposed by the American Academy of Pediatricians (AAP).11
According to AAP president Sally Goza, MD, “This move is incredibly misguided. In the middle of a pandemic, what families are looking for is reassurance and clinical guidance from the doctors they trust most to care for their children: pediatricians.”12
Dr. Goza adds:
This unprecedented expansion of pharmacies’ ability to administer vaccines to children is not a solution to the vaccine hesitancy that is driving down rates of childhood immunizations in the U.S. Many parents have questions about their children’s vaccines, and pediatricians are ready to talk with them. It’s what we do, every day, one-on-one with thousands of parents, as part of the long-term trusting relationships that families have with their physicians.13
- Associated Press. Pharmacists can give childhood vaccines, U.S. officials say. NBC News Aug. 19, 2020.
- U.S. Department of Health and Human Services. HHS Expands Access to Childhood Vaccines during COVID-19 Pandemic. Aug. 19, 2020.
- Santoli J. Effects of the COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and Administration — United States, 2020. MMWR May 15, 2020; 69(19): 591-593.
- AP. Pharmacists in all 50 states are now allowed to give childhood vaccinations. CBS News Aug. 19, 2020.
- See Footnote 3.
- Inserro A. HHS Gives Pharmacists Ability to Deliver Childhood Vaccines, Upsetting AAP. AJMC Aug. 19, 2020.
- American Academy of Pediatrics. American Academy of Pediatrics Opposes HHS Action on Childhood Vaccines; Calls It ‘Incredibly Misguided’. Aug. 19, 2020.
- AAP, Accreditation Council for Pharmacy Education, ACIP, ACPE, Advisory Committee on Immunization Practices, Alex Azar, American Academy of Pediatricians, CDC, Centers for Disease Control and Prevention, COVID-19, Department of Health and Human Services, FDA, Food and Drug Administration, HHS, National Vaccine Information Center, NVIC, PREP, Public Readiness and Emergency Preparedness Act, Rishma Parpia, Sally Goza, The Vaccine Reaction