Emergent BioSolutions and the Biomedical Advanced Research and Development Authority (BARDA) have reached "a mutual agreement" to terminate a pandemic preparedness contract the Maryland CDMO has held since 2012.
During a third-quarter earnings call, Emergent announced the end of the contract that established a public-private partnership for pandemic preparedness and designated the company's Baltimore manufacturing facility as a Center for Innovation and Advanced Development and Manufacturing (CIADM). According to the CDMO, this also terminates "all associated task orders, including the 2020 task order to reserve capacity and expand manufacturing for third-party COVID-19 vaccine and therapeutic candidates."
Launched in 2006, BARDA, as part of the U.S. Department of Health and Human Services (HHS), aids the development of various medical countermeasures for a range of chemical, nuclear, biological or viral threats. In 2009, BARDA tapped Emergent’s Bayview facility in Baltimore to become a part of the government's pandemic-response manufacturing infrastructure. A few years later, Emergent struck a deal with BARDA who co-funded an expansion at the facility so that it could be used for production in the event of a pandemic. When the COVID-19 pandemic struck, the government issued a task order leveraging the plant to make the bulk drug substance for the J&J and AstraZeneca candidates
But since then, Emergent has been plagued with manufacturing issues, including an incident last April where Emergent (depending on which media report you read) either conflated the ingredients or had an employee move from AstraZeneca’s section of the plant to J&J section without taking precautions. Either way, the result was a contaminated batch – up to 15 million doses – of J&J's vaccine.
Emergent, in a statement filed with the Securities and Exchange Commission, said the modifications to its contract with BARDA "reduced the total contract value to be realized under the Task Order to $470.9 million from $650.8 million. The total base CIADM Contract value to be realized was reduced to $140.5 million from $163.2 million."
