After the Sept.11 terror attacks and the anthrax attacks on government officials and others, the US government planned to begin stockpiling smallpox antivirals based on advice from biodefense experts.
On Tuesday, Mar. 12, the manufacturer of the smallpox antiviral drug, Arestvyr, Siga Technologies delivered the first shipment of the drug under the Biomedical Advanced Research and Development Authority (BARDA) contract.
Arestvyr (Tecovirimat) is one of the first novel drugs to be developed, procured and now delivered to the Strategic National Stockpile under the post-9/11 legislative authority known as Project BioShield.
Developed to serve as a therapeutic drug for treatment of smallpox, whether resulting from a terrorist attack, biowarfare or a new natural outbreak, Arestvyr is an investigational new drug not yet approved or licensed as safe and effective by the U.S. Food and Drug Administration (FDA). Arestvyr was formerly known as ST-246.
The tentative contract for 1.7 million doses of what was then known as ST-246 was first reported in late 2010.
However, there is some debate whether a couple of million doses, which go at a high price of $200 per course, is really necessary for a viral disease that was eradicated over four decades ago.
One expert says no.
According to a New York Times report yesterday, Dr. Richard H. Ebright, a bioweapons expert at Rutgers University, said there was little need for so much Arestvyr since the country has raised its stockpile of smallpox vaccine to 300 million doses now, up from only 15 million in 2001.
“Is it appropriate to stockpile it? Absolutely,” he said. “Is it appropriate to stockpile two million doses? Absolutely not. Twenty thousand seems like the right number.”
The Siga President disagrees.
Dr. Eric A. Rose justified the sale by saying, “There are 80 million courses of Tamiflu in the strategic national stockpile,” he said. “Smallpox is just as contagious and has 30 times the mortality. By measures like that, I’d say 2 million is on the low end.”
All known stocks of variola virus (smallpox) stocks are kept under security at two places: the Centers for Disease Control and Prevention (CDC) in Atlanta and the State Research Centre of Virology and Biotechnology, Koltsovo, Novosibirsk Region, Russia.
The Strategic National Stockpile (SNS) is the United States’ national repository of antibiotics, vaccines, chemical antidotes, antitoxins and other critical medical equipment and supplies.
In the event of a national emergency involving bioterrorism or a natural pandemic, the SNS has the capability to supplement and re-supply local health authorities that may be overwhelmed by the crisis, with response time as little as 12 hours. The SNS is jointly run by the CDC and the Department of Homeland Security.
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