As a result of a delay in the federal review and approval process for Pfizer-BioNTech’s new COVID-19 vaccine pediatric formulation for children ages 6 months to 4 years, advance orders of the new product (maroon cap) previously submitted by Ohio vaccine providers have been canceled, and deliveries originally planned for February 21 will not take place. In addition, new advance orders are no longer available through the ImpactSIIS Vaccine Ordering Management System (VOMS).
The U.S. Food and Drug Administration (FDA) postponed its advisory panel’s meeting scheduled for February 15 to review an emergency use authorization (EUA) request for Pfizer-BioNTech’s maroon cap product, pending review of newly available clinical trial data. A new meeting date has not been set yet.
The Vaccines and Related Biological Products Advisory Committee meeting is the first step in that review process, followed by FDA authorization, then review and evaluation from the Centers for Disease Control and Prevention following an EUA.
Vaccine providers with questions may call the Ohio Department of Helath Provider Call Center at 1.844.9ODHVAX (1.844.963.4829) between 8 a.m. and 5:30 p.m. Mondays through Fridays or email COVIDVACCINE@odh.ohio.gov.