|
| ||||||||
| ||||||||
|
Biosecurity News in Brief
Delays in Anthrax Vaccine Delivery Raise Concerns about BioShield ProcessBy David Press, August 18, 2006 An August 15, 2006 article in the San Jose, CA Mercury News highlights recent concerns about delivery of a new anthrax vaccine being developed by VaxGen and funded by the Department of Health and Human Services (HHS). The new vaccine, called rPA102, is to be one the biggest deliverables of HHS’ Project BioShield, a $5.6 billion countermeasure procurement program, However, the process recently has come under fire due to delays in testing and contract disputes that could prevent release of the vaccine until late 2008, 2 years after its anticipated release.[1] The U.S. government has an existing anthrax vaccine, AVA, made by Emergent BioSolutions of Maryland, which was approved by the U.S. Food and Drug Administration (FDA) in the 1950s. AVA is currently used to inoculate only U.S. military personnel. The drawbacks of the AVA vaccine are that it is documented to have caused six vaccine-related deaths and a number of unfavorable side effects. It also requires multiple shots within in an 18-month period for effectiveness.[1] Although AVA is considered generally safe and effective by the National Academies’ Institute of Medicine (IOM), in March 2002, IOM concluded that a new vaccine was “urgently needed"[1] due to significant advances in scientific knowledge of vaccine immune response and effectiveness which have occurred since development of the AVA vaccine. Based in part on the IOM recommendation, in March 2004 HHS offered an $877.5 million contract under Project BioShield to any company that could provide 75 million doses of a new anthrax vaccine to be stored in the Strategic National Stockpile (SNS) for civilian use in the event of a mass bioterrorism attack. VaxGen, a small biopharmaceutical company in the San Francisco Bay area, was awarded the contract in November 2004, but has been slow to release the vaccine. Under the BioShield contract, VaxGen will be paid for work on rPA102 only when vaccine has been delivered to the Strategic National Stockpile. The first delivery was scheduled for earlier this year. However, VaxGen has had recent troubles with the vaccine’s formulation which will push back the delivery date to the end of 2006 or beginning of 2007, and possibly into late 2008. HHS has added to delays in delivery by requiring additional safety and efficacy tests that VaxGen maintains were not agreed upon in the original contract. This potential contract dispute between VaxGen and HHS over production of rPA102 has government and industry experts worried that other biotech and pharmaceutical companies will not be interested in partnering with HHS for Project BioShield contracts. “This is the first major contract,” said Chris Colwell, a regulatory specialist with the Biotechnology Industry Organization. “Many people are watching this.” Representative Tom Lantos of California, voiced his concern to HHS officials in June saying that “an unresolved dispute here will not only leave the nation without a much-needed, next-generation anthrax vaccine, but will also undermine the development of a vibrant bio-defense industry."[1] References
|