As part of ongoing preparedness efforts against biodefense threats, the U.S. Department of Health and Human Services (HHS) will purchase smallpox vaccine, called ACAM2000, to build and replenish vaccine stored in the Strategic National Stockpile (SNS) over the next decade.
Under the agreement announced today, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), which oversees the SNS, will award approximately $170 million to Emergent BioSolutions of Gaithersburg, Maryland, for the purchase this year. ASPR can purchase additional vaccine over the next 10 years, with a target of $2 billion in procurement and surge options for up to a total of nearly $2.8 billion.
The U.S. Food and Drug Administration licensed the smallpox vaccine in 2007 for people at high risk for smallpox infection. To be cost-efficient, the SNS rotates stored smallpox vaccine to DoD for military members deploying to high-risk areas, and HHS then replenishes the vaccine stockpile.
Smallpox is a serious and highly infectious disease caused by the variola virus; historically, 30 percent of people with the infection died. Following a global public health campaign, which relied on vaccination, the World Health Organization (WHO) declared the disease eradicated in 1980. Samples of the virus remain in two top-security laboratories, one in the United States and the other in Russia, for use in developing vaccines, treatments and diagnostic tests for smallpox infections.
“Smallpox is one of the most contagious and deadly infections known to humankind,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, MD. “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.”
The United States has a long-standing commitment to the international community to develop two vaccines and two treatments for smallpox infections.
To meet that obligation, the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, continues to work with federal and private partners to develop an additional vaccine that can be administered safely to people with weakened immune systems or who are at high risk of adverse reaction to traditional smallpox vaccines, as well as to develop antiviral drugs. The first of those drugs, TPOXX, or tecovirimat, received FDA approval in 2018.
Information from US Department of Health & Human Services.