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Baxter Admits H5N1
Vax Contamination

From Alan Cantwell MD

Jeff - This is the Baxter 'defense' ... it's NOT reassuring!
Baxter claims the vaccine was not for human use. Here is a spokesperson (B-V) for Baxter with comments below.  It's interesting that vaccines for animal use are NOT routinely tested for contaminants. This would be a possible hazard for veterinarians and animal researchers. -Alan
Brenn-Vogt: As this material was not produced for human use, testing for potential contamination is not routinely carried out. Baxter sent this material to AVIR Greenhills in Austria, they, in turn, reported to us later that they sent it to four labs with whom they contract. As explained above, this was not the result of a lack of security but it was due to a unique combination of process, technical and human error in a procedure used for this specific research project. 
LifeGen.de: After the Anthrax mailings in 2001, which is no Baxter related case, but not less risky, this is the second virological contamination starting directly from the US. How will Baxter prevent future accidents like the one in Europe for the future? 
Brenn-Vogt: Exposure was highly unlikely -- the individuals working with the experimental material were operating in laboratory containment conditions specifically designed to prevent exposure. All H5N1 infections that have been reported to date have been associated with direct exposure to infected poultry/birds. 
As mentioned above, this incident originated in Austria, not the US. The circumstances of the contamination were a unique combination of process, technical and human errors. Cross-contamination of commercial product, clinical material or other experimental material has been absolutely excluded. The public health authorities in Austria performed an audit at Baxter's research facility in Austria (Feb. 16) and Baxter's corrective and preventative actions were found appropriate by the auditors. The contamination occurred only during the process for this specific research project for AVIR Greenhills in Baxter's facility. Further details about the process will not be discussed as it is proprietary information. 
LifeGen.de: Will the contamination in Europe lead to management changes in your company? 
Brenn-Vogt: No.  
Baxter - Vax Products Contained Bird Flu Virus
By Calisha Myers
Deerfield, IL-based Baxter International has confirmed that vaccine shipments sent to subcontractors in Czech Republic, Slovenia and Germany were contaminated with live H5N1 avian flu viruses. The contaminated product, which Baxter calls "experimental virus material," was a mix of H3N2 seasonal flu viruses and H5N1 viruses produced at the company's research facility in Orth-Donau. The problem was discovered when ferrets inoculated with the experimental mix died. Baxter was notified on February 6, but has kept quiet about the details surrounding the mix-up, the Canadian Press reports.
"At this juncture we are confident in saying that public health and occupational risk is minimal at present," medical officer Roberta Andraghetti said. "But what remains unanswered are the circumstances surrounding the incident in the Baxter facility in Orth-Donau."
According to the Sun, Christopher Bona, said in an email that the release of the product was a result of a combination of "just the process itself, (and) technical and human error in this procedure" and the company has taken steps to make sure it doesn't happen again. TheCanadian Press reports that Bona has said that the contaminated product was not a vaccine and was developed for testing in animals only. Austrian authorities have audited operations at the facility and are satisfied with the corrective actions taken. Baxter has also worked with the subcontractors to help them destroy the contaminated products and clean up their facilities. Staff exposed to the products were offered Tamiflu and assessed by infectious disease doctors, the company tells the Canadian Press.
While H5N1 doesn't easily infect humans, the H3N2 vaccine can. As the Sun points out, someone infected with both strains could serve as an incubator for reassortment, producing a hybrid virus able to transmit easily among people. But according to Andraghetti, there is no evidence reassortment occurred. "And we have no evidence of any increased transmissibility of the viruses that were involved in the experiment with the ferrets in the Czech Republic," she added.
- check out the Canadian Press article

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