According to the Centers for Disease Control and Prevention, 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. But the virus still exists in laboratory stockpiles, 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.
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 20 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 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.
But 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. 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 email 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."
The law creating Project Bioshield authorized $5.6 billion over 10 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.
Former Sens. Bob Graham (D-Fla.) and Jim Talent (R-Mo.), who co-chaired the Commission on the Prevention of Weapons of Mass Destruction, sent a letter to President Obama this week, urging him to save Project Bioshield, the Los Angeles Times reported. A funding cut, Graham warned "will drive a stake through the heart of America's fledgling biodefense efforts."
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 U.S. within 12 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 transporation costs.