In anticipation of COVID-19 vaccinations for children ages 5-11 beginning as quickly as possible after the federal review and authorization process is complete, the Ohio Department of Health (ODH) is sharing Interim Provider Guidance for Pfizer-BioNTech COVID-19 Vaccines for Children Ages 5-11.
The Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 will be a new product configuration with new packaging, new preparation, and a new national drug code (NDC). The current product for adults and adolescents should not be used in children.
The interim guidance, which will be updated following further action and recommendations by the U.S. Food & Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) and their advisory panels, is intended to help Ohio COVID-19 Vaccine Providers plan for the rollout of the Pfizer pediatric formulation in the coming weeks.
- Packaging and dosage
- Storage and handling
- Pediatric considerations
- Ordering
- Data reporting
- Messaging.
The following key steps in the federal review process are anticipated during the next couple weeks:
- The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Tuesday, October 26, on this topic
- The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Tuesday-Wednesday, November 2-3
- Providers should be ready to vaccinate children 5-11 years old shortly thereafter, pending FDA authorization and CDC recommendations.
Ordering Process and Deadline for Initial Orders
Providers can order the Pfizer-BioNTech Pediatric Formulation now. Initial orders were due at noon on October 20. Providers can request vaccine through the Vaccine Ordering Management System (VOMS) in the Impact Statewide Immunization Information System (ImpactSIIS). VOMS is open for providers to place orders 24 hours a day, 7 days a week.
NOTE: During the initial ordering period, providers will be required to order a minimum of 300 doses. During later weeks, you will be able to order in increments of 100.
Orders of the Pfizer-BioNTech pediatric vaccine formulation will not be shipped until authorization has been granted by the FDA. Doses cannot be administered until the CDC makes its recommendations, which are expected in early November.
Ordering Webinar
Providers unable to attend the October 19 webinar about ordering pediatric COVID-19 vaccine can view the COVID-19 Vaccine: Pediatric Vaccine Overview and How to Order Doses Through VOMS presentation online.
The ODH COVID-19 Provider website is a hub for a variety of resources for vaccine providers. Vaccine providers with questions may call the ODH Provider Call Center at 1.844.9ODHVAX (1.844.963.4829) between 8 a.m. and 7 p.m. Mondays through Fridays or email COVIDVACCINE@odh.ohio.gov.