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Baxter admits flu product contained live bird flu virus

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.

Quote:

Är det räven som vaktar hönshuset så att säga ?

"Vaccines as Biological Weapons? Live Avian Flu Virus Placed in Baxter Vaccine Materials Sent to 18 Countries" by Mike Adams (naturalnews.com) - March 3, 2009.
http://www.naturalnews.com/025760.html

"Baxter admits flu product contained live bird flu virus" The Canadian Press (ctv.ca) - Feb. 27 2009.
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Pressmedelande.



EMEA ger positivt omdöme för CELVAPAN
– det första cellbaserade vaccinet mot pandemisk influensa


Kliniska resultat från fas III-studie och efterföljande boosterstudie bekräftar säkerhet, immunsvar och korsskyddsminne.

KISTA, den 21 januari 2009 – Europeiska läkemedelsverkets (EMEA) kommitté för humanläkemedel (CHMP) har utfärdat ett positivt omdöme för godkännande för försäljning av Baxters CELVAPAN i EU. CELVAPAN är det första cellbaserade pandemiska vaccinet mot H5N1 (fågelinfluensa).

Det positiva omdömet föregår ett godkännande av prototypvaccinet (s.k. mock-up-vaccin), som tillåter att CELVAPAN används om Världshälsoorganisationen (WHO) officiellt deklarerar en pandemi. Det positiva omdömet är baserat på resultaten från ett omfattande kliniskt utvecklingsprogram, bland annat en klinisk fas III-prövning. Den visade att vaccin mot två olika H5N1-virusstammar tolererades väl och gav ett skyddande immunsvar.

”Vi är mycket nöjda med att få EMEAs positiva omdöme för CELVAPAN”, säger Hartmut Ehrlich, M.D., Vice President för forskning och utveckling inom Baxters division BioScience. ”Detta är ytterligare ett steg mot vårt mål att kunna leverera ett säkert och effektivt vaccin som skyddar befolkningen mot en eventuell influensapandemi.”


http://www.baxter.se/om_baxter/pressr ... smeddelande_20090121.html