MODERNA PEDIATRIC COVID-19 VACCINE

CDC Office of Acquisition Services awarded multiple indefinite delivery, indefinite quantity (IDIQ) contracts for the National Center for Immunization and Respiratory Diseases (NCIRD) for the purchase of standard commercial pediatric COVID vaccines, manufactured under a current establishment and product license issued by the U.S. Food and Drug Administration (FDA).  The vaccines awarded under these contracts will be purchased for NCIRD’s immunization awardees (the fifty state health departments, several large city program and current and former U.S. Territories) to support immunization programs as provided under Section 317(j) of the Public Health Service Act and Vaccine for Children (VFC) program, as established pursuant to Section 13631of the Omnibus Budget Reconciliation Act of 1993.  Orders for the vaccines on these contracts are ordered through the NCIRD electronic vaccine ordering system. The initial contracts were established to support the public sector ACIP recommended COVID vaccinations for children 0 - 18 years of age.  The Moderna contract will be modified to support additional purchase of doses for the licensed pediatric COVID vaccine (SPIKEVAX) with an age indication of  6 months to 11 years.  With no declared public health emergency and the existence of licensed products for all applicable age groups, a decision is expected to remove COVID vaccines with Emergency Use Authorization (EUA) designations from the market.  This means the Pfizer pediatric COVID vaccine with an EUA for ages 6 months to 4 years will no longer be available to support the VFC program.  This will leave Moderna's COVID vaccine with the age indication of 6 months to 11 years as the only licensed product in the US for children 6 months to 4 years.  As such, it is in the best interest of the government to increase Moderna's available doses to mitigate the removal of the Pfizer product. CDC intends on awarding a sole source follow on action to Moderna to allow for the additional purchase of the licensed pediatric COVID vaccine. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.