$2 Billion Dollar HHS Contract Awarded for Smallpox Vaccine

Emergent BioSolutions ACAM2000 is a live vaccinia virus smallpox vaccine

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Emergent BioSolutions Inc. announced the U.S. Department of Health and Human Services (HHS) has awarded an agreement valued at approximately $2 billion dollars over 10 years for the continued supply of ACAM2000®, a smallpox vaccine.

This contract for the procurement of ACAM2000 vaccine consists of a one-year base period of performance, valued at approximately $170 million, and 9 option years. 

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 on April 1, 2008. 

Emergent said on September 3, 2019, in a press release ‘it expects to deliver into the Strategic National Stockpile (SNS) a majority of the doses under the base year by year-end 2019.’ 

The ACAM2000 vaccine is currently stockpiled both in the USA and internationally.

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.

The actual number of ACAM2000 doses to be delivered to the SNS is dependent on certain timing and tiered-pricing terms. This agreement supports the U.S. government’s policy to maintain a vaccine stockpile to be able to protect every American from smallpox.

Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopoxvirus family. Smallpox is one of the most devastating diseases with a mortality rate as high as 30 percent, said the company.

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 the smallpox virus are at high risk for developing and transmitting smallpox and should be vaccinated with a replication-competent smallpox vaccine unless severely immunodeficient, says the CDC.

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Abbey Jenkins, SVP and vaccines business unit head at Emergent, said in the press release, “As the only smallpox vaccine administered in 1-dose, ACAM2000 vaccine remains the primary smallpox vaccine for general population use in the event of a smallpox emergency.”

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 of experiencing severe vaccination complications must be weighed against the risk of 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 sequelae and/or death.

Please see Prescribing Information for full boxed warning and additional safety information.

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.

Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats.

Published by Precision Vaccinations