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Monday, December 23rd, 2024

HHS awards 10-year contract to Emergent BioSolutions for smallpox vaccine

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Emergent BioSolutions Inc. said Tuesday it was awarded a contract for its smallpox vaccine from the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $2 billion over 10 years.

The contract specifically supports the continued supply of Emergent’s ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (SNS). The HHS agreement reaffirms ACAM2000 as a critical component of U.S. preparedness against the threat of smallpox as a biologic weapon.

“Emergent applauds the U.S. government’s continued focus on national security demonstrated through its long-term stockpiling strategy, which ensures a sustainable supply of critical medical countermeasures such as ACAM2000 vaccine, and its investment in a stable domestic manufacturing infrastructure to help protect the U.S. population against smallpox in the event of an attack,” Robert G. Kramer, president and CEO of Emergent BioSolutions, said. “Awarded on the heels of our recently announced contract to supply our Vaccinia Immune Globulin Intravenous or VIGIV therapeutic, this contract solidifies our role as a solutions provider supporting the government’s smallpox preparedness efforts and helping fulfill their needs with our smallpox franchise.”

Under the terms of the contract, ASPR will award approximately $170 million to Emergent for one-year’s worth of ACAM2000 vaccines, with nine option years following. While the target of $2 billion in procurement, surge options during those years could increase to a total of nearly 2.8 billion.

The HHS and Emergent agreement follows the conclusion of a previous 10-year, $425 million contract, which established domestic warm-base manufacturing capabilities and procure smallpox vaccines issued by the U.S. government on April 1, 2008.

In 2015, the Centers for Disease Control and Prevention (CDC) issued clinical guidance for smallpox vaccine use in a post-event scenario, stating that surveillance and containment activities including vaccination with replication-competent smallpox vaccine such as ACAM2000 will be the primary response strategy for achieving epidemic control.

“As the only smallpox vaccine administered in one dose, ACAM2000 vaccine remains the primary smallpox vaccine for general population use in the event of a smallpox emergency,” Abbey Jenkins, SVP and vaccines business unit head at Emergent, said.

Smallpox is a highly infectious disease, where historically 30 percent of people with the infection died, according to HHS. The World Health Organization (WHO) declared the disease eradicated in 1980.

“Smallpox is one of the most contagious and deadly infections known to humankind,” noted HHS Assistant Secretary for Preparedness and Response Robert Kadlec.

“We do not know whether all samples of the virus, outside of two WHO-designated labs, actually have been found and destroyed; at the same time, synthetic biology for technology continues to advance and in the future could allow smallpox to be created as a bioweapon. For those reasons, the virus remains a potential threat to national and global health security. Having vaccines and treatments at-the-ready will be imperative to saving lives,” Kadlec said.

ACAM2000 is the primary smallpox vaccine specifically designated for use in a bioterrorism emergency. Nearly 269 million doses have been supplied to the U.S. SNS since 2007. It continues to be one of the lowest priced vaccines that the U.S. government procures across all relevant vaccine programs.