Quest for Anthrax Vaccine Lengthens - Questions Surface After Deal Is Voided
http://www.washingtonpost.com/wp-dyn/content/article/2006/12/20/AR2006122001826.html?referrer=email
By Renae Merle, Washington Post Staff Writer
The cancellation of a high-profile contract to produce 75 million doses of a new anthrax vaccine leaves federal health officials years away from a replacement for the version now in use but could raise the prospects for an alternative being developed by a British competitor.
VaxGen of Brisbane, Calif., was scheduled to begin delivering a new anthrax vaccine this year, but after delays and technical problems, the Department of Health and Human Services voided the $877.5 million contract Tuesday. The department has not announced plans to replace it, but an alternative version being developed by Avecia of Manchester, England, is being tested, and the National Institutes of Health is expected to award contracts next year for research into advanced vaccines.
The VaxGen contract was the largest piece of the Bush administration's $5.6 billion Project BioShield, which seeks to develop modern vaccines and drugs to counter chemical, biological, radiological or nuclear threats.
"The first thing to do, on HHS's part, is to explain why this failed," said Tara O'Toole, director of the Center for Biosecurity at the University of Pittsburgh Medical Center. "All of the companies are wondering, does this mean that HHS is an unreliable partner, or that this was just kind of bad luck?"
HHS canceled the contract after VaxGen missed its deadline Monday to begin human testing because of concerns at the Food and Drug Administration about the product's reliability. Agency officials declined to elaborate on the reasons for the cancellation.
VaxGen was to develop a replacement for a version of the vaccine currently used by the military and made by Emergent BioSolutions of Gaithersburg. That drug must be administered over 18 months in six shots and has been subject to controversy. Some soldiers have resisted being vaccinated and others have complained about side effects, but the FDA has said the drug is safe.
HHS had hoped that VaxGen's vaccine could be produced more quickly in an emergency and administered over a shorter period of time. "It just illustrates the uncertainty that surrounds developing a vaccine. Even in the best of circumstances, it's a risky undertaking," said Robert Kadlec, the former director for biodefense on the White House's Homeland Security Council. "But when you put it in the hands of a company that hasn't had a proven product, it's even chancier."
It is unclear how soon any of the alternatives could be produced. Emergent is working on improvements to its vaccine, including halving the number of shots required and extending its shelf life beyond three years, a company spokesman said. The U.S. Army Medical Research Institute of Infectious Diseases plans to spend $14 million in fiscal 2007 researching anthrax vaccines as well as treatments and diagnostic tools.
Avecia, which has an NIH contract to develop a vaccine, may be the closest to an alternative. The company has produced some preliminary data from human tests, Michael Kurilla, director of the Office of Biodefense Research Affairs at NIH, said. "So far the vaccine has been demonstrated to be safe," Kurilla said. But those human trials are not completed and the FDA will review the results, he said. It is unclear how long it would take for the product to be ready for wide distribution.
"There are still a number of specific actions you have to do in terms of bringing a product to commercial-scale production," Kurilla said.
In June, Avecia was awarded a $4 million grant from the National Institute of Allergy and Infectious Diseases to develop another version of the vaccine that would not need refrigeration. "That is much earlier in the pipeline," Kurilla said. An Avecia spokesman did not return a call for comment.
The NIH is also spearheading research on a third generation of the vaccine. That version could be stored at room temperature, would require fewer doses, and would not require a needle, Kurilla said. One or more contracts will be awarded next year, he said. "This is not something that is going to be a short-term event," he said.
By Renae Merle, Washington Post Staff Writer
The cancellation of a high-profile contract to produce 75 million doses of a new anthrax vaccine leaves federal health officials years away from a replacement for the version now in use but could raise the prospects for an alternative being developed by a British competitor.
VaxGen of Brisbane, Calif., was scheduled to begin delivering a new anthrax vaccine this year, but after delays and technical problems, the Department of Health and Human Services voided the $877.5 million contract Tuesday. The department has not announced plans to replace it, but an alternative version being developed by Avecia of Manchester, England, is being tested, and the National Institutes of Health is expected to award contracts next year for research into advanced vaccines.
The VaxGen contract was the largest piece of the Bush administration's $5.6 billion Project BioShield, which seeks to develop modern vaccines and drugs to counter chemical, biological, radiological or nuclear threats.
"The first thing to do, on HHS's part, is to explain why this failed," said Tara O'Toole, director of the Center for Biosecurity at the University of Pittsburgh Medical Center. "All of the companies are wondering, does this mean that HHS is an unreliable partner, or that this was just kind of bad luck?"
HHS canceled the contract after VaxGen missed its deadline Monday to begin human testing because of concerns at the Food and Drug Administration about the product's reliability. Agency officials declined to elaborate on the reasons for the cancellation.
VaxGen was to develop a replacement for a version of the vaccine currently used by the military and made by Emergent BioSolutions of Gaithersburg. That drug must be administered over 18 months in six shots and has been subject to controversy. Some soldiers have resisted being vaccinated and others have complained about side effects, but the FDA has said the drug is safe.
HHS had hoped that VaxGen's vaccine could be produced more quickly in an emergency and administered over a shorter period of time. "It just illustrates the uncertainty that surrounds developing a vaccine. Even in the best of circumstances, it's a risky undertaking," said Robert Kadlec, the former director for biodefense on the White House's Homeland Security Council. "But when you put it in the hands of a company that hasn't had a proven product, it's even chancier."
It is unclear how soon any of the alternatives could be produced. Emergent is working on improvements to its vaccine, including halving the number of shots required and extending its shelf life beyond three years, a company spokesman said. The U.S. Army Medical Research Institute of Infectious Diseases plans to spend $14 million in fiscal 2007 researching anthrax vaccines as well as treatments and diagnostic tools.
Avecia, which has an NIH contract to develop a vaccine, may be the closest to an alternative. The company has produced some preliminary data from human tests, Michael Kurilla, director of the Office of Biodefense Research Affairs at NIH, said. "So far the vaccine has been demonstrated to be safe," Kurilla said. But those human trials are not completed and the FDA will review the results, he said. It is unclear how long it would take for the product to be ready for wide distribution.
"There are still a number of specific actions you have to do in terms of bringing a product to commercial-scale production," Kurilla said.
In June, Avecia was awarded a $4 million grant from the National Institute of Allergy and Infectious Diseases to develop another version of the vaccine that would not need refrigeration. "That is much earlier in the pipeline," Kurilla said. An Avecia spokesman did not return a call for comment.
The NIH is also spearheading research on a third generation of the vaccine. That version could be stored at room temperature, would require fewer doses, and would not require a needle, Kurilla said. One or more contracts will be awarded next year, he said. "This is not something that is going to be a short-term event," he said.
