Novavax COVID-19 Adjuvanted Vaccine

Waiver Rationale Summary

CDC has a requirement for 30 million doses of commercially available COVID-19 vaccine doses with an adult indication from all U.S. licensed or authorized COVID-19 vaccine brands. Awarding contracts for all U.S. licensed or authorized COVID-19 vaccine provides greater provider brand choice and ensures a sufficient supply of vaccines to meet CDC program needs. CDC's solicitation included FAR 52.225-5, Trade Agreements. Based on the offers received in April 2024, there are insufficient U.S. made or designated country end products under the Trade Agreements Act (TAA) to fulfill CDC's need. CDC cannot award contracts for all U.S. licensed or authorized COVID-19 vaccine brands with an adult indication without accepting the non-TAA compliant offer from Novavax, which manufacturers its vaccines in India, which is not a designated country. Because the statutory waiver to the Buy American statue (BA) cannot be applied to Novavax's offer, the BA requirements are then applicable. The BA exception at FAR 25.103(b)(2) for an individual determination of domestic nonavailability is being requested to support the award of a contract for a foreign end product, Novavax's COVID-19 Adjuvanted vaccines manufactured in the United States; indeed, there are no doses of Novavax's COVID-19 Adjuvanted vaccine manufactured in the United States. CDC's requirement to award contracts for all U.S. licensed or authorized COVID-19 vaccine brands with an adult indication cannot be met without accepting this foreign end product.