Throw out old anthrax vaccine, expert tells U.S.
http://news.yahoo.com/s/nm/20071023/sc_nm/anthrax_vaccine_usa_dc_1
By Maggie Fox, Health and Science Editor Tue Oct 23, 7:05 PM ET
WASHINGTON (Reuters) - The U.S. government needs to throw away more than $12 million worth of expired anthrax vaccine and quickly use up the rest of a rapidly aging supply worth hundreds of millions of dollars, a Government Accountability Office expert said on Tuesday.
A report from the GAO, the investigative arm of Congress, shows that the Health and Human Services Department signed an overly optimistic contract with a struggling biotech company to make anthrax vaccine -- a contract that VaxGen Inc could never realistically have been expected to fill.
That deal was scuttled in January after it became clear that VaxGen would not be able to fill the order.
HHS must now find a way to use up rapidly aging stockpiles of anthrax vaccine and come up with better ways to contract for new and improved vaccines, the GAO said.
"Three lots of BioThrax vaccine in the stockpile have already expired, resulting in losses of over $12 million," the GAO's Keith Rhodes told a hearing of the Senate's Homeland Security and Governmental Affairs Committee.
"According to the data provided by U.S. Centers for Disease Control and Prevention, 28 lots of BioThrax vaccine will expire in calendar year 2008. (HHS) paid approximately $123 million for these lots."
More than $100 million a year worth of this vaccine could be lost as it expires, the GAO said.
The U.S. military routinely vaccinates troops against anthrax, a naturally occurring bacteria that can kill humans and cattle and can also be developed into a biological weapon.
This need became acute after October 2001, when 22 people were infected and five died after someone mailed letters containing finely milled anthrax spores to politicians and media outlets in New York, Washington and Florida in a crime that has never been solved.
The current vaccine, BioThrax, is based on old technology. It is irritating, causes side effects and requires six doses and annual boosters.
HHS contracted with VaxGen in 2002 to make a new and better vaccine but the contracts were too ambitious, the GAO said, because VaxGen was a small biotechnology firm still in the early stages of developing a vaccine and had not addressed many critical manufacturing issues.
"The contract required VaxGen to deliver 25 million doses of the vaccine in two years, which would have been unrealistic even for a larger manufacturer," the report added.
Sen. Susan Collins, a Maine Republican said: "This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste."
"HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons," said Collins, the ranking Republican on the committee.
A simple single inventory system for BioThrax with rotation based on a first-in, first-out principle, could help address the problem, Rhodes advised.
VaxGen, based in South San Francisco, California, has slashed its work force after the scuttled HHS deal.
By Maggie Fox, Health and Science Editor Tue Oct 23, 7:05 PM ET
WASHINGTON (Reuters) - The U.S. government needs to throw away more than $12 million worth of expired anthrax vaccine and quickly use up the rest of a rapidly aging supply worth hundreds of millions of dollars, a Government Accountability Office expert said on Tuesday.
A report from the GAO, the investigative arm of Congress, shows that the Health and Human Services Department signed an overly optimistic contract with a struggling biotech company to make anthrax vaccine -- a contract that VaxGen Inc could never realistically have been expected to fill.
That deal was scuttled in January after it became clear that VaxGen would not be able to fill the order.
HHS must now find a way to use up rapidly aging stockpiles of anthrax vaccine and come up with better ways to contract for new and improved vaccines, the GAO said.
"Three lots of BioThrax vaccine in the stockpile have already expired, resulting in losses of over $12 million," the GAO's Keith Rhodes told a hearing of the Senate's Homeland Security and Governmental Affairs Committee.
"According to the data provided by U.S. Centers for Disease Control and Prevention, 28 lots of BioThrax vaccine will expire in calendar year 2008. (HHS) paid approximately $123 million for these lots."
More than $100 million a year worth of this vaccine could be lost as it expires, the GAO said.
The U.S. military routinely vaccinates troops against anthrax, a naturally occurring bacteria that can kill humans and cattle and can also be developed into a biological weapon.
This need became acute after October 2001, when 22 people were infected and five died after someone mailed letters containing finely milled anthrax spores to politicians and media outlets in New York, Washington and Florida in a crime that has never been solved.
The current vaccine, BioThrax, is based on old technology. It is irritating, causes side effects and requires six doses and annual boosters.
HHS contracted with VaxGen in 2002 to make a new and better vaccine but the contracts were too ambitious, the GAO said, because VaxGen was a small biotechnology firm still in the early stages of developing a vaccine and had not addressed many critical manufacturing issues.
"The contract required VaxGen to deliver 25 million doses of the vaccine in two years, which would have been unrealistic even for a larger manufacturer," the report added.
Sen. Susan Collins, a Maine Republican said: "This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste."
"HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons," said Collins, the ranking Republican on the committee.
A simple single inventory system for BioThrax with rotation based on a first-in, first-out principle, could help address the problem, Rhodes advised.
VaxGen, based in South San Francisco, California, has slashed its work force after the scuttled HHS deal.
