What’s the news: Ahead of the anticipated emergency use authorization (EUA) of Pfizer-BioNTech’s COVID-19 vaccine for children 5–11 years old, White House officials have announced a vaccination plan that represents a departure from the approach the country took with adults.
That is because it relies more heavily on physicians, clinics and pharmacies instead of mass-vaccination sites. Physicians will also be enlisted to help work with parents to get children vaccinated. The Pfizer-BioNTech vaccine for 5–11-year-olds will have a new product configuration, new national drug code (NDC), and will come with smaller vials and needles than those for adults and adolescents.
An independent advisory committee of the Food and Drug Administration (FDA) will meet Oct. 26 to consider Pfizer’s EUA application and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices committee will consider the matter Nov. 2–3.
If authorized by the FDA and recommended by the CDC, the Pfizer-BioNTech COVID-19 vaccine for 5–11-year-olds will be a dose and formula that is specific for this age group and should not be mixed with the COVID-19 vaccines for adults and adolescents. The vaccine’s packaging will also come in smaller configurations, which will make it easier for physician offices and other relatively small organizations to offer the vaccine.
Each package will contain 10-dose vials in cartons of 10 vials each and can be stored for up to 10 weeks at standard refrigeration temperatures or six months at ultracold temperatures. The vaccine will also come with supplies needed to better serve kids, including smaller needles. The Biden administration said it has secured enough pediatric doses to vaccinate the country’s 28 million children who are between 5–11 years old.
The administration’s plan also involves:
- Standing up vaccination sites in settings that kids and their parents know and trust. This will include vaccination clinics at doctors’ offices, hospitals, pharmacies, community health centers and school- and community-based sites.
- Supporting education and engagement efforts to build public trust. A national public education campaign will be launched to reach parents and guardians to provide accurate and culturally responsive information about the vaccine and risks that COVID-19 poses to children.
“The fact is, physicians are the single most trusted source of vaccine information, and their offices are the most preferred location to get vaccinated,” said White House Vaccinations Coordinator Bechara Choucair, MD. “Pediatricians, family doctors and those in the Vaccines For Children (VFC) program will be an essential part of our strategy to vaccinate 5–11-year-olds, and we strongly encourage those who are not already enrolled to enroll to administer the COVID-19 vaccine. We stand ready to support them in any way we can.”
Doctors and other health professionals interested providing COVID-19 vaccination and are part of a health system should reach out to their organization’s point of contact. Physicians and health professionals in independent practice who are interested should contact their state or local immunization program.
Find out more from the CDC about how to enroll to provide COVID-19 vaccines.
Why it’s important: While the start of the vaccination campaign depends on the FDA and CDC process and timeline, the planning efforts mean that physician practices should be ready to begin getting shots in arms in the days following the final recommendation.
The AMA “is pleased by the Biden administration’s advance planning and collaboration to ensure enough vaccine supply is available, and that it’s accessible at places parents and kids know and trust, specifically at their own physician’s practice,” said AMA President Gerald E. Harmon, MD. “Recent polling indicates that parents are eager to vaccinate their children and protect them from COVID-19.”
“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Dr. Harmon added. “We encourage all parents to get their children vaccinated against COVID-19 once vaccines are authorized and recommended for use in this population.”
Millions of teenagers have already been fully vaccinated against COVID-19. For those who are fully vaccinated, they are 10 times less likely to be hospitalized with COVID-19 and even have a high degree of protection against the Delta variant. Without vaccination, the consequences of pediatric COVID-19 cases can be serious and last for months.
Learn more: The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF) and another to address physicians’ COVID-19 vaccine questions (PDF).
