Emergent BioSolutions announced the contract had been awarded by the Office of the Assistant Secretary for Preparedness and Response (ASPR), part of the US Department of Health and Human Services (HHS).
Under the contract, the company will supply vaccinia immune globulin intravenous (VIGIV), a product for the treatment of complications due to smallpox vaccination, into the US Strategic National Stockpile (SNS).
The 10-year contract consists of a one-year base period of performance, valued at $23m (€20.2m), and further nine years that would bring the total value to approximately $535m.
During the first year, Emergent will use plasma provided by the US government to manufacture VIGIV doses – all subsequent years will involve plasma collection and production efforts.
VIGIV is the only product approved by the US Food and Drug Administration (FDA) for its purpose and has been stockpiled at a ratio of one dose per 10,000 doses of first- or second-generation smallpox vaccine.
Preparedness against smallpox
The company already supplied the SNS with ACAM2000, the only licensed smallpox vaccine in the US, under a contract for the establishment of domestic warm base manufacturing and product delivery.
Emergent has completed the delivery of doses and is now negotiating a follow-on contract for uninterrupted supply of the medical countermeasure.
The US Center for Disease Control and Prevention (CDC) originally contracted Acambis to develop the product and provide doses to the SNS in 2000. Acambis received approval for ACAM2000 in 2007 and was acquired by Sanofi in 2008. In 2017, Emergent acquired ACAM2000 from Sanofi for $97.5m.
“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,” said the company’s CEO, Robert Kramer.
A treatment for the same disease, created by SIGA Therapeutics in coordination with several US departments, was recently approved by the FDA.
The need for a supplementary product
According to the company’s SVP and head of antibody therapeutics business unit, Laura Saward, VIGIV is a ‘critical component’ of the government's preparedness strategy.
VIGIV is proven to treat infection from live vaccinia contained in ACAM2000. The most severe complication from the smallpox vaccine is the potential to develop myocarditis and pericarditis, which are inflammation and swelling of the heart and surrounding tissue.
The supplementary product was developed on Emergent's hyperimmune platform with funding by HHS ASPR, later being approved by the FDA in 2005 and by Health Canada in 2007.
Abbey Jenkins, head of Emergent’s vaccines and anti-infectives business unit, told us that the company is a ‘longstanding, trusted and reliable’ partner to the SNS and “strives to be responsive to the needs of the US government by enhancing the nation’s state of readiness.”
Emergent has also been supplying SNS with BioThrax (Anthrax Vaccine Adsorbed), and recently announced plans to deliver AV7909, a next generation anthrax vaccine, following a contract with Biomedical Advanced Research and Development Authority (BARDA).
Delivery of AV7909 is expected to begin in the second half of 2019.
Emergent is also the supplier for Anthrasil (Anthrax Immune Globulin Intravenous), BAT (Botulism Antitoxin Heptavalent A, B, C, D, E, F, G) and Raxibacumab, a human monoclonal antibody for inhaled anthrax.