Emergent BioSolutions awarded $535 mln contract from HHS to support smallpox preparedness

The U.S. Department of Health and Human Services (HHS) has awarded a 10-year, $535 million contract to Emergent BioSolutions Inc. for the supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile in support of smallpox preparedness.

VIGIV is the only therapeutic licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination and has been stockpiled at a ratio of one dose of VIGIV per 10,000 doses of first or second generation smallpox vaccine, the company said on Monday.

The award went through HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR). VIGIV was developed on Emergent’s hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Anthrasil, an anthrax vaccine.

“Emergent is pleased to continue its successful track record of being a solutions provider to governments to help address serious public health threats such as smallpox,” Robert Kramer Sr., president and chief executive officer of Emergent BioSolutions, said. “VIGIV is the only product licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination.”

Kramer said the VIGIV contract, along with Emergent’s ACAM2000 smallpox vaccine, are key components of the U.S. government’s preparedness and response strategy to protect the public’s health against the threat of smallpox.

The contract consists of a one-year base period of performance valued at $23 million with nine option years after that. That would bring the total contract value to approximately $535 million.

“Through this 10-year contract with HHS, Emergent is honored to continue its long-term partnership with the U.S. government, whose support of the VIGIV program reflects its commitment to protect the population against serious public health threats,” Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent, said. “The VIGIV product has been a critical component of the government’s preparedness strategy, dating back to 2002 when it was first procured for inclusion in the stockpile.”

The scope of work under the contract includes the collection of plasma, manufacturing, and delivery of the finished drug product. During the first year, Emergent will use plasma provided by the U.S. government to manufacture VIGIV doses, while all subsequent years will involve Emergent-led plasma collection and production efforts.

This multi-year contract follows the conclusion of a one-year, $26 million procurement contract signed with the U.S. government in February 2018.