Operation Warp Speed, the White House-created program to speed up COVID-19 vaccine candidate development and manufacturing domestically, will benefit from a $628 million expansion of an existing public-private partnership with Emergent BioSolutions Inc., the U.S. Department of Health and Human Services (HHS) and the company announced Monday.
The government’s task order with Emergent is worth approximately $628 million and falls under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of HHS’s Office of the Assistant Secretary for Preparedness and Response.
Together, BARDA and Emergent intend to build on a 2012 Center for Innovation in Advanced Development and Manufacturing (CIADM) partnership as a means of rapidly increasing production of leading COVID-19 vaccine candidates through 2021. One of the nation’s three CIADM facilities was managed by Emergent’s Baltimore Bayview facility, and will now be the first tapped to support Operation Warp Speed. As part of these efforts, Emergent will also provide contract development and manufacturing (CDMO) services to the government.
“Before a vaccine is even approved, Emergent’s manufacturing capabilities will pave the way for drug companies with candidates approaching approval to begin turning out doses,” HHS Secretary Alex Azar said on June 1. “Securing more manufacturing capacity here in America for candidates that make it to the final stages of Operation Warp Speed will help get a vaccine to American patients without a day wasted.”
Emergent’s commitment is valued at approximately $542.75 million and involves the company deploying its molecule-to-market CDMO offering and committing manufacturing capacity for production of COVID-19 vaccine candidates through 2021. In addition, the task order includes $85.5 million to be invested in the rapid expansion of the company’s viral and non-viral CDMO drug product fill and finish capacity for both vaccine and therapeutic manufacturing. Included in the partnership will be investments in Emergent’s Baltimore Camden and Rockville facilities, with an eye on bolstering a U.S.-based manufacturing supply chain for pharmaceutical and biotechnology efforts.
“Emergent is proud of this expanded BARDA partnership that symbolizes confidence in our development and manufacturing capabilities that have served the U.S. government’s needs for more than two decades,” Robert Kramer Sr., president and CEO of Emergent BioSolutions, said. “Our longstanding record of delivering safe and effective medical countermeasures for public health positions us to continue to help at this critical moment by advancing COVID-19 vaccine programs of our fellow innovators in the industry.”
Emergent is also collaborating with Johnson & Johnson, Novavax and Vaxart to develop and manufacture their COVID-19 vaccine candidates. For its COVID-19 vaccine response, Emergent’s integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at the Baltimore Bayview facility, and drug product manufacturing at Emergent’s Baltimore Camden and Rockville facilities.
“This innovative solution paves the way for pharmaceutical and biotechnology innovators with leading COVID-19 vaccine candidates to have an established U.S. development and manufacturing supply chain,” Syed Husain, senior vice president and CDMO business unit head at Emergent, said. “This investment in increased capacity and capabilities will serve the industry’s expanding clinical and commercial pipelines more broadly, ultimately benefiting more patients globally.”