Emergent BioSolutions, Inc.’s Center for Innovation in Advanced Development and Manufacturing (CIADM) received a task order on Monday valued at up to $21.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture a Zika vaccine.
Three cGMP lots of the developed and manufactured vaccine will be used in a Phase 1 clinical trial. BARDA will provide a base vaccine candidate, while Emergent BioSolutions will conduct technology transfer of process materials and information, process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to the cGMP manufacture of bulk drug substance and final drug product.
“Emergent is pleased to partner with BARDA to address the emerging public health threat in Zika,” Adam Havey, executive vice president and president of the biodefense division of Emergent BioSolutions, said. “We look forward to executing on this task order and working collaboratively with the government in its efforts to help contain this epidemic.”
Sixty countries and territories currently report ongoing mosquito-borne transmissions of Zika virus, including 46 countries with a first Zika virus outbreak since 2015, no previous evidence of circulation and ongoing transmission by mosquitos. Fourteen additional countries reported evidence of Zika virus transmission between 2007 and 2014, as well as ongoing transmission.
Monday’s task order includes a 30-month base valued at $17.9 million, as well as options that would bring the total value up to $21.9 million if executed.
The order also marks the first Zika-related BARDA Task Order awarded to Emergent BioSolutions under the CIADM program. Emergent BioSolutions was designated as a CIADM in 2012 by the U.S. Department of Health and Human Services, allowing it to contract with the U.S. government through task oder requests for such requirements as operational readiness, the development and manufacturing of CBRN products, warm base maintenance, surge manufacturing, and workforce development.