Emergent BioSolutions announced a contract award by 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 for the continued supply of ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (SNS). The actual number of ACAM2000 doses to be procured is dependent on certain timing and tiered-pricing terms that are subject to the discretion of ASPR. ACAM2000 vaccine is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
“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. 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. It is one of the unique ways we live out our mission – to protect and enhance life,” Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, said.
This contract for the procurement of ACAM2000 vaccine consists of a one-year base period of performance, valued at approximately $170 million, and nine option years. The company expects to deliver into the SNS a majority of the doses under the base year by year end 2019, the effect of which is already included in the company’s full year financial forecast, which was recently reaffirmed on August 1. This multiple year contract is intended to support the replacement of the smallpox vaccine stockpile and follows the conclusion of a prior 10-year, $425 million contract to establish domestic warm-base manufacturing capabilities and procure smallpox vaccines issued by the U.S. government April 1, 2008. ACAM2000 continues to be one of the lowest priced vaccines that the U.S. government procures across all relevant vaccine programs.
“The U.S. government’s long-term commitment to smallpox preparedness and the role ACAM2000 vaccine serves have been reinforced in guidance and legislation within the last two decades,” Abbey Jenkins, SVP and vaccines business unit head at Emergent, said. “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. We are proud of our employees, especially those at our Canton, Massachusetts and Rockville, Maryland locations, who are dedicated to producing this critical countermeasure. Because of their work, Emergent stands ready to continue our partnership with HHS in fulfilling this contract.”
Smallpox vaccines have been foundational to the U.S. government’s preparedness and response efforts as documented in the Project BioShield Act of 2004 and its predecessor the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. 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. Persons exposed to smallpox virus are at high risk for developing and transmitting smallpox and should be vaccinated with a replication-competent smallpox vaccine unless severely immunodeficient.
Contract 75A50119C00052 is funded by the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
ACAM2000 vaccine is the primary smallpox vaccine designated for use in a bioterrorism emergency, with almost 269 million doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000 vaccine is also licensed in Australia and Singapore and is currently stockpiled both in the U.S. and internationally.
ACAM2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
The labeling for ACAM2000 contains a contraindication for individuals with severe immunodeficiency. Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000. The risk for experiencing severe vaccination complications must be weighed against the risk for experiencing a potentially fatal smallpox infection.
Additionally, there are warnings and precautions for myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson Syndrome), eczema vaccinatum resulting in permanent sequelae or death, ocular complications; blindness and fetal death have occurred following either primary vaccination or revaccination with live vaccinia virus smallpox vaccines. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequalae and/or death.
Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopox virus family. According to the CDC, it is one of the most devastating diseases with a mortality rate as high as 30%. Smallpox is classified by the CDC as a Category A bioterrorism agent and the U.S. government continues to invest in countermeasures to protect the nation from this threat. Governments around the world are also taking precautionary measures to be ready to deal with a potential smallpox outbreak.