Washington, DC—While some immunization sites planned to begin administering COVID-19 vaccines to youngsters aged 12 through 15 years shortly after the FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for that group, pharmacies were urged to check specific state policies first.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.” Previously, only those age 16 years and older could get the vaccine.
Before loading up the syringes, however, pharmacists might want to review local rules and regulations and directives from state licensing boards on vaccination of youths, according to FDA officials.
“Our authorization is for across all of the United States, so it applies everywhere,” said Peter Marks, MD, PhD, director of FDA Center for Biologics, Evaluation and Research, at an FDA media briefing. “It’s just who can administer a vaccine may vary from jurisdiction to jurisdiction. It may be [that] the local pharmacy is not able to.”
That might be less of a problem than feared because of action last year by the Department of Health and Human Services (HHS). The HHS issued an amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) last fall as some children returned to daycare, preschool, and school. Concerns had been raised about dropping rates of routine childhood immunization.
Based on the amendment, state-licensed pharmacists—and licensed and registered pharmacy interns acting under their supervision—were allowed to order and administer vaccines to young people ages 3 through 18 years, subject to several requirements.
Among the requirements are that:
• The vaccine must be approved or licensed by the FDA.
• The vaccination must be ordered and administered according to the national CDC’s Advisory Committee on Immunization Practices 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). Included in the training program must be 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. It also 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 2 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.
Exactly how all of that applies to expanded use of COVID-19 vaccines is still being determined, according to Dr. Marks, because “terms of agreement may vary from state to state.”
The FDA points out that, from March 1, 2020 through April 30, 2021, about 1.5 million confirmed COVID-19 cases occurred in children and teenagers aged 11 to 17 years although younger people tend to have a milder COVID-19 disease course compared with adults.
Now the agency has determined that the Pfizer-BioNTech product has met the statutory criteria to amend the EUA, adding that “the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.”
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Dr. Marks suggested. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
The FDA also has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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