Baxter: Product contained live bird flu virus
By Helen Branswell, THE CANADIAN PRESS
Last Updated: 27th February 2009, 3:26pm
The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses.
And an official of the World Health Organization’s European operation said the body is closely monitoring the investigation into the events that took place at Baxter International’s research facility in Orth-Donau, Austria.
“At this juncture we are confident in saying that public health and occupational risk is minimal at present,” medical officer Roberta Andraghetti said from Copenhagen, Denmark.
“But what remains unanswered are the circumstances surrounding the incident in the Baxter facility in Orth-Donau.”
The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany.
The contamination incident, which is being investigated by the four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the product and they died. Ferrets shouldn’t die from exposure to human H3N2 flu viruses.
Public health authorities concerned about what has been described as a “serious error” on Baxter’s part have assumed the death of the ferrets meant the H5N1 virus in the product was live. But the company, Baxter International Inc., has been parsimonious about the amount of information it has released about the event.
On Friday, the company’s director of global bioscience communications confirmed what scientists have suspected.
“It was live,” Christopher Bona said in an email.
The contaminated product, which Baxter calls “experimental virus material,” was made at the Orth-Donau research facility. Baxter makes its flu vaccine — including a human H5N1 vaccine for which a licence is expected shortly — at a facility in the Czech Republic.
People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.
Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences.
While H5N1 doesn’t easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people.
That mixing process, called reassortment, is one of two ways pandemic viruses are created.
There is no suggestion that happened because of this accident, however.
“We have no evidence of any reassortment, that any reassortment may have occurred,” said Andraghetti.
“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.”
Baxter hasn’t shed much light — at least not publicly — on how the accident happened. Earlier this week Bona called the mistake the result of a combination of “just the process itself, (and) technical and human error in this procedure.”
He said he couldn’t reveal more information because it would give away proprietary information about Baxter’s production process.
Andraghetti said Friday the four investigating governments are co-operating closely with the WHO and the European Centre for Disease Control in Stockholm, Sweden.
“We are in very close contact with Austrian authorities to understand what the circumstances of the incident in their laboratory were,” she said.
“And the reason for us wishing to know what has happened is to prevent similar events in the future and to share lessons that can be learned from this event with others to prevent similar events. ... This is very important.”
Source: TorontoSun
Baxter confirme qu'elle a fabriqué un produit contaminé par le virus H5N1
Il y a 5 jours
TORONTO — La compagnie Baxter a confirmé, vendredi, qu'elle a fabriqué un vaccin expérimental qui a accidentellement été contaminé par le virus H5N1de la grippe aviaire.
Dr Roberta Andraghetti, une porte-parole de l'Organisation mondiale de la santé (OMS), a affirmé que l'OMS suivait de près l'enquête qui retrace le fil des événements ayant mené à cette bévue.
"A ce stade-ci du processus, nous pouvons affirmer que les risques pour la santé publique et pour les professionnels ayant été mis en contact avec le virus sont à un très bas niveau", a-t-elle déclaré.
L'erreur, que les autorités de santé publique ont décrite comme étant "grave", a eu lieu au laboratoire de recherche de Baxter International à Orth-Donau, en Autriche. Mais les circonstances entourant l'incident sont encore floues.
Le produit contaminé, un mélange de virus de la grippe humaine H3N2 et de virus de la grippe aviaire H5N1 qui n'étaient pas correctement identifiés, a été envoyé à l'entreprise Avir Green Hills Biotechnology, une firme autrichienne. Celle-ci a par la suite transmis des portions du mélange à des sous-traitants en République tchèque, en Slovénie et en Allemagne.
C'est le sous-traitant tchèque qui s'est rendu compte que quelque chose ne tournait pas rond, lorsque des furets auxquels il avait injecté le mélange sont morts. Ceux-ci ne devraient pas mourir après une exposition au virus H3N2, ce qui signifiait donc qu'ils avaient également reçu le virus actif du H5N1.
Christopher Bona, porte-parole de Baxter, a confirmé l'information vendredi. Mais la compagnie n'a livré que peu de détails entourant l'incident.
Des spécialistes en biosécurité se sont montrés fort préoccupés du fait que le virus de grippe humaine H3N2 ait été mélangé avec le virus de la grippe aviaire H5N1. Il s'agit d'une pratique dangereuse qui devrait être interdite, ont signifié plusieurs experts.
Une propagation accidentelle du mélange de H5N1 et de H3N2 aurait pu mener à des conséquences désastreuses.
Le H5N1 ne contamine pas facilement les humains, mais le H3N2 si. Dans l'éventualité où une personne exposée au mélange était infectée simultanément par les deux souches, elle pourrait servir d'incubateur à un virus hybride capable de se propager facilement d'un humain à un autre.
Ce mélange de souches, appelé réassortiment, est l'une des deux manières de créer un virus pandémique.
Mais rien ne laisse croire qu'un tel phénomène se soit passé dans ce cas-ci.
"Nous n'avons aucune information nous portant à croire qu'il y a eu un quelconque réassortiment", a dit Dr Roberta Andraghetti.
Copyright © 2009 The Canadian Press. Tous droits réservés.
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