Public healthNew smallpox vaccine delivered to U.S. national stockpile

The U.S. federal government has stockpiled the nation’s first smallpox vaccine made especially for people with compromised immune systems, including those with HIV, even though smallpox has been eradicated.

According to the Centers for Disease Control and Prevention (CDC), the last case of smallpox in the United States was in 1949, and the last naturally occurring case in the world was in Somalia in 1977. The virus still exists in laboratory stockpiles, however, and after the terrorist attacks on 9/11, “there is heightened concern that the variola virus might be used as an agent of bioterrorism,” the CDC says.

Susan Jones writes in CNSnews.com that under a Bush-era program called Project Bioshield, a Danish company, Bavarian Nordic, received a $505 million contract from the U.S. government in 2007 to manufacture and deliver twenty million doses of smallpox vaccine for “immune-compromised populations.”

“Addressing the needs of such special populations is mandated under the Pandemic and All-Hazards Preparedness Act (PAHPA),” the Health and Human Services Department (HHS) said in a news release announcing delivery of the first million doses of the special smallpox vaccine to the U.S. Strategic National Stockpile.

Delivery of the first new smallpox vaccine began in May and will continue through 2013.

Press reports note that Project Bioshield itself may be nearing an end, just as it delivers its first new vaccine. According to a report in the Hill, a war supplemental bill passed by the House cuts $2 billion from Project Bioshield, whose effectiveness has been questioned by the Obama administration (“Senators harshly criticize plan to cut $2 billion from BioSheild,” 23 July 2010 HSNW). President George W. Bush, who signed legislation creating Project Bioshield in 2004, said it would help America purchase, develop and deploy cutting-edge defenses against catastrophic attack. “Project BioShield is part of a broader strategy to defend America against the threat of weapons of mass destruction,” Bush said at the time.

In an e-mail to the Los Angeles Times, Obama White House spokesman Nick Shapiro said Project BioShield “has demonstrated limited success in providing incentive for private-sector (vaccine) developers and has not provided a robust pipeline of medical countermeasures.”

Jones writes that the law creating Project Bioshield authorized $5.6 billion over ten years for the government to purchase and stockpile vaccines and drugs to fight smallpox, anthrax, and other potential bioterror agents. The contract is administered by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

In an emergency, such as the smallpox virus being obtained from a secure lab and used in an act of terrorism, the vaccine may be authorized for use to protect people who have weakened immune systems, specifically HIV persons who have not progressed to AIDS, HHS said.

The Strategic National Stockpile is operated by the Centers for Disease Control and Prevention. It contains large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, and if that medicine is ever needed, it can be delivered to any state in the United States within twelve hours, HHS said.

BARDA says it is now supporting Bavarian Nordic’s work to develop a freeze-dried version of the specially formulated smallpox vaccine, which would have a longer shelf-life and incur lower storage and transportation costs.