- 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.
- 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