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.

 

The interim guidance document includes preliminary information about:

·                 Packaging and dosage

·                 Storage and Handling

·                 Pediatric considerations

·                 Ordering

·                 Data Reporting

·                 Messaging

·                 The U.S. Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on this topic Oct. 26.

·                 The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Nov. 2-3.

·                 Providers should be ready to vaccinate children 5-11 years old shortly thereafter, pending FDA authorization and CDC recommendations.

Providers can order the Pfizer-BioNTech Pediatric Formulation now. Initial orders are due at noon on Wednesday, Oct. 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.

Providers who were unable to attend the Oct. 19 webinar about ordering pediatric COVID-19 vaccine can view the presentation COVID-19 Vaccine: Pediatric Vaccine Overview and How to Order Doses Through VOMS.

The Ohio Department of Health 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.

coronavirus.ohio.gov