The U.S. government has entered into a 10-year contract potentially worth over $2 billion with Emergent BioSolutions Inc. to buy supplies of its smallpox vaccine for the nation's emergency stockpile.
The Department of Health and Human Services is paying $170 million to Emergent in 2019 to buy a one-year supply of the smallpox vaccine, known as ACAM2000, and has an option for nine more years of the product under the agreement.
Smallpox is one of the deadliest and most contagious infections known to humankind, said Robert Kadlec, HHS' assistant secretary for preparedness and response. The disease kills about 30% of people with the infection.
The World Health Organization declared smallpox eradicated in 1980, but health officials have raised concerns the disease could reemerge as a bioterrorism agent. Routine vaccination of the American public for smallpox was stopped in 1972 and now a large proportion of the U.S. population has no immunity against the disease.
Samples of the virus remain in two top-security laboratories — one in the U.S. and the other in Russia — for use in developing vaccines, treatments and diagnostic tests for smallpox infections.
Outside of those two labs, health officials are uncertain about where else the virus may be lurking and if all samples have been found and destroyed, Kadlec said.
In July 2014, the National Institutes of Health discovered decades-old vials of smallpox in a storage room on its Bethesda, Md., campus associated with a high-containment laboratory operated by the U.S. Food and Drug Administration.
Synthetic biology technology also continues to advance and in the future could allow smallpox to be created as a bioweapon, Kadlec said.
"For those reasons, the virus remains a potential threat to national and global health security," he said in a Sept. 3 statement. "Having vaccines and treatments at-the-ready will be imperative to saving lives."
Emergent's ACAM2000 was licensed by the FDA in 2007 for people at high risk of acquiring smallpox. The company acquired the vaccine from Sanofi in October 2017. Sanofi obtained the vaccine when it bought Acambis, the original developer, in 2008.
Before ACAM2000 was available, Americans were vaccinated against smallpox with Dryvax, manufactured by Wyeth Laboratories Inc., a company acquired in 2009 by Pfizer Inc.
Strategic National Stockpile
HHS said it is buying ACAM2000 to build and replenish supplies of the vaccine stored in the Strategic National Stockpile, a cache of drugs and medical equipment deployed to areas of the U.S. in the event of a manmade or natural disaster or other emergencies.
The stockpile, which is overseen by Kadlec's office, rotates stored smallpox vaccine to the U.S. Department of Defense for military members deploying to high-risk areas. HHS then replenishes the product for its stockpile.
"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," said Robert Kramer, president and CEO of Emergent BioSolutions.
The U.S. Biomedical Advanced Research and Development Authority, a component of Kadlec's office, is continuing to work with federal and private partners to develop an additional smallpox vaccine that could be administered safely to people with weakened immune systems or those at high risk of adverse reactions to ACAM2000 or Dryvax, HHS said. BARDA is also funding the development of antiviral drugs against the disease.
The agency helped fund the development of SIGA Technologies Inc.'s smallpox antiviral Tpoxx, which was approved in the U.S. in 2018.