WASHINGTON — The U.S. Department of Health and Human Services (HHS) issued a third amendment – PDF to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to lifesaving childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the United States return to daycare, preschool and school.

Alex Azar

“Today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,” said HHS Secretary Alex 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.”

The amendment authorizes State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his or her State board of pharmacy) to order and administer vaccines to individuals ages three through 18 years, subject to several requirements:

• 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) immunization 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).  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 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.

The above requirements are consistent with many States that already permit licensed pharmacists to order and administer vaccines to children.

A May 2020 Centers for Disease Control and Prevention (CDC) report found a troubling drop in routine childhood immunizations as a result of families staying at home. While families followed public health warnings about going out, an unfortunate result was many missed routine vaccinations. This decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by the COVID-19 pandemic.

“As a pediatric critical care physician who has treated critically ill children suffering from vaccine preventable diseases, I know first-hand the devastation to the child – and to the family and community – of a death or severe brain damage that could have been avoided by a safe and effective vaccine,” said HHS Assistant Secretary for Health Brett Giroir, M.D.  “The cornerstone of public health, vaccines, makes these dreaded diseases preventable. As we expand options during the COVID-19 response, we are also reminding parents, grandparents, and caretakers that there is no substitute for a critically important well-child visit with a pediatrician or other licensed primary care provider when available.”

HHS is expanding access to childhood vaccines to avoid preventable diseases in children, additional strains on the healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with an additional resurgence of COVID-19.