Emergent BioSolutions given FDA approval to manufacture smallpox vaccine in Mass. facility

The Emergent BioSolutions Inc. facility in Canton, Massachusetts, will soon be manufacturing the ACAM2000 smallpox vaccine, thanks to approval of a license by the U.S. Food and Drug Administration (FDA) this week.

ACAM2000 is notable for being the only FDA-licensed vaccine for active immunization against smallpox for those designated high risk. It’s also the primary vaccine held in the Strategic National Stockpile (SNS) for bioterrorism emergencies.

Emergent BioSolutions is a global life sciences company focused on addressing public health threats for both civilian and military populations.

“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 contract manufacturing operations business unit head of Emergent BioSolutions, said.

Smallpox remains one of the world’s deadliest diseases, with the Centers for Disease Control and Prevention (CDC) marking its mortality rate as high as 30 percent.

Kirk said the milestone Emergent BioSolutions achieved marked the culmination of almost a decade of investment and dedication of its colleagues at the Canton facility.

“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,” Kirk said.

ACAM2000 is also licensed in Australia and Singapore. More than 230 million doses of the vaccine have been supplied to the SNS, and governments in other countries also have taken measures to counter a potential smallpox outbreak.

The business of the vaccine production was recently acquired by Emergent BioSolutions, along with a live viral fill and finish facility in Rockville, Maryland. Along with that has come a 10-year contract with the CDC based on maintaining the country’s readiness against smallpox. That contract has a remaining value of $160 million. With the approval of the Canton facility, Emergent BioSolutions expects to complete production of vaccines for the existing CDC contract in early 2019.