FDA Approves Emergent’s Smallpox Vaccine

Emergent BioSolutions said that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) in the company’s newly-acquired cGMP live viral manufacturing facility in Canton, MA. ACAM2000 is the only FDA-licensed vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

“Finalizing and receiving FDA licensure for the tech transfer of ACAM2000 manufacturing at the Canton facility is a significant step forward in support of the U.S. government’s strategy of establishing domestic capabilities to manufacture an FDA-licensed smallpox vaccine,” said Sean Kirk, senior vice president manufacturing operations and CMO business unit head, Emergent BioSolutions. “Emergent is pleased to achieve this milestone, which is the culmination of almost a decade of investment and dedication of our colleagues at the Canton site. Licensure of this facility helps to ensure that ACAM2000 remains the cornerstone of the U.S. government’s smallpox preparedness efforts, while at the same time positions Emergent to meet the demands of international customers.”

In its acquisition of the ACAM2000 business, Emergent also acquired a live viral fill/finish facility in Rockville, MD that will be responsible for the processing of bulk ACAM2000 into final packaged vaccine vials. Emergent also assumed responsibility for a 10-year contract with the Centers for Disease Control and Prevention (CDC), originally valued at $425 million, to maintain readiness against smallpox. The contract has a remaining value of $160 million for the delivery of ACAM2000 to the Strategic National Stockpile (SNS). With the approval of the Canton facility, Emergent expects to complete all remaining product deliveries under the existing CDC contract in early 2019.