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Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

I think the danger is now past and I don't doubt all the players have cleaned up physically and procedurally the key thing now is to not allow this to just go away. How the contamination occurred is the problem; the vaccine and live H5N1 should never have been anywhere near each other. I am not surprised Baxter are not willing to discuss this but am surprised this story has not been picked up much more widely in the MSM. My fear is that if it remains below the radar of the larger media players it may not be adequately investigated, the results of any investigation will not be made public and lessons learnt will not be disseminated to all those who are working with dangerous pathogens.

Precisely well commented in this post text, and at your post #17, J.J.:

"a pathogen which should only be handled in BSL3 facilities has been allowed out of the lab and sent across international boarders"

We have in EU-zone, where are the same EU laws, that one compyna, by outsourcing other companies, make dangerous moves:

#17:
"H3N2 seasonal flu vaccine was contaminated with HPAI H5N1 at an Austrian Baxter plant in a procedure which they are unable to go into but has been discontinued.
These samples were then sent to AVI Greenhills, also in Austria, who Baxter had a contract with and they sub contracted the testing to Biotest.
They also sent some of the vaccine to a company in Slovenia."


Such practice must be corrected by new laws on the matter if neccessary, to disable such tampering with deadly viruses and diseases (laws which instead of squeezing the zone food producers/vendors by some "at the detail" non essential declarations and procedures, must shield us better from other dangerous matters).
If not, sooner or later it would start to came out death cases as it was elsewhere with some company dialisys materials at the time.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

EMEA is on the case:

- snip -

Updated: The Austrian branch of pharmaceutical companies Barter is checked the European Agency for the Evaluation of Medicinal Products (EMEA). Pharmacists in the Austrian Ortho sent to the Czech Republic to test defective influenza vaccine.

http://www.blesk.cz/clanek/zpravy-d...pky-ve-vakcine-zmeni-se-kvuli-tomu-zakon.html
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

EMEA is on the case:

- snip -

Updated: The Austrian branch of pharmaceutical companies Barter is checked the European Agency for the Evaluation of Medicinal Products (EMEA). Pharmacists in the Austrian Ortho sent to the Czech Republic to test defective influenza vaccine.

http://www.blesk.cz/clanek/zpravy-d...pky-ve-vakcine-zmeni-se-kvuli-tomu-zakon.html

From Dutchy's link (machine translation)

His staff now will have the Austrian side to explain what went wrong and who is responsible for it.

"It was a procedural error, which took place in our office, you can not tell the details. I revealed our trade secrets. I can not make sure that we immediately take measures to ensure that similar errors have happened," said U.S. spokesman Richard Baxter Tischler.​
It was Tischler I spoke to this morning. I also asked how the contamination occurred and was told the procedure was propitiatory but I suspect that will not wash when regulatory officials are asking the questions.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

From the above link, part excerpt text:


"immunization experiment carried out at 10 fretkách.
Experiment byl povolen MPO pod číslem 13/5009, který byl zaměřen na ověření účinnosti intranasálně aplikované vakcíny proti
The experiment was authorized MPO under number 13/5009, which was aimed at verifying the effectiveness of intranasálně administered vaccine
viru sezónní chřipky A (H3N2).
seasonal influenza virus A (H3N2). "


So the (live?) intranasal vaccine authorized to be used was only for an seasonal AH3N2 type.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

so, where comes the H5N1 from ?

Baxter is known to actually run vaccination experiments
with H5N1 in Europe.
See the video from cologne posted earlier.

They also produce prepandemic vaccine for national stockpiles in Bohumil
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

so, where comes the H5N1 from ?

Baxter is known to actually run vaccination experiments
with H5N1 in Europe.
See the video from cologne posted earlier.

They also produce prepandemic vaccine for national stockpiles in Bohumil

As A.D. wroted well in its #7 post:

"I wonder what was "supposed" to happen and what "really" happened?"


Or it would pop out some picked/located "sacrificed-goat"/...,

or we can start to speculate about internationaly non-authorized field events ...
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

I do not think there is anything sinister here. I think a mistake was made in the Baxter lab contaminating some H3N2 seasonal flu vaccine, due to be used in trials, with H5N1. Avir Green Hills got their H3N2 in good faith and forwarded it on to two labs for testing. Biotest and the Slovenian lab both thought they were getting H3N2 and handled it as such. The questions all revolve around how Baxter managed to contaminate H3N2 with H5N1, which has very tight handling restrictions. This is an appalling breach and deserves some kind of explanation and quite possibly a prosecution.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

H5N1, which has very tight handling restrictions.
Obviously not tight enough. I'd pay money to hear what was said when they were told an *oops* happened.

I hope someone keeps the pressure on to get to the bottom of this.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

There is a little more detail in this piece.
http://translate.google.co.uk/trans...ls=org.mozilla:en-US:official&hs=ETz&as_qdr=w

Below is a Machine Translated extract covering the new info.


<table width="100%" border="0" cellpadding="0" cellspacing="0"><tbody><tr><td>Laboratory incident through contaminated with H5N1 flu vaccine

</td></tr><tr><td style="padding-top: 5px;"> Health & Medicine </td></tr><tr><td class="pr_from" style="padding-top: 5px;"> Press release from: WAI - Science Forum Avian Influenza </td></tr><tr><td class="pr_txt" style="padding: 5px 0pt 30px;">


<script>Ads_BA_conditionalAD('CAD');</script><script type="text/javascript" language="javascript" src="http://ad.doubleclick.net/adj/P4574.openpr.de/gesundheit;tile=2;sz=336x280,300x250;kw=;wf=CAD;ord=1734414998038419.2?"></script><!-- Zaehlpixel 300x250 --> <!-- EAID (Ad) : 197191416 EPID (Zone) : 22865876 ESID (Site) : 534812 ERID (Rendering) : 25577304 ECID (Creative) : 25559447 EKID (Key) : 0 EADV (Advertiser) : 1660572 EENV (Environment) : j ERV (RenderVersion): 1 EBUY (Order) : 2770493 C (Click) : http://ad.doubleclick.net/click;h=v...876;4307-300/250;25559447/25577304/1;;~sscs=? U (URL) : http://businessad.de T (Target) : _blank N (Random) : 8022374 -->

So far unexplained is the relationship of the laboratory incident in the Czech Republic to a report of the Press and Information Service of the City of Vienna 11.02.
in ?​
in which it is stated that the Vienna Otto Wagner Hospital, quote: "18 employees of an outside company out-patients [were], because the moment could not be excluded that in the context of their work with a bird flu pathogen had come into contact .
According to the WAI arises, however, may be a causal link with a simultaneously taking place in Vienna Phase I study of an H5N1 vaccine live in the Austrian pharmaceutical company Baxter, in which as a "nasal spray" designed bird flu vaccine tested on humans.
Whether the contamination of the vaccines actually in human phase I study in Vienna effect is unclear, but it would plausible to explain why at 11.02.
Five days after a laboratory accident by contaminated vaccine in the Czech Republic - Austria Vienna in 18 people in the Otto-Wagner-Spital preventively against H5N1 should be treated.

Although the laboratory incident now as a "Biological Hazard" from the EDIS (Emergency and Disaster Services ") under the name BH-20090217-20552-CZE is listed, Baxter had been no public opinion forced.

The Science Forum avian influenza, therefore, strongly urges a full and detailed disclosure of the circumstances for which a vaccine contamination with highly pathogenic agents have led.

The pharmaceutical manufacturer Chiron (now part of Switzerland's Novartis AG) had 46 million doses of flu vaccine "Fluvirin" due to bacterial contamination must be destroyed.

</td></tr></tbody></table>
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

The pharmaceutical manufacturer Chiron (now part of Switzerland's Novartis AG) had 46 million doses of flu vaccine "Fluvirin" due to bacterial contamination must be destroyed.
Is this something new?
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

From the JJ post #30 of the WAI text:

"Although the laboratory incident now as a "Biological Hazard" from the EDIS (Emergency and Disaster Services ") under the name BH-20090217-20552-CZE is listed, Baxter had been no public opinion forced."
...
"According to the WAI arises, however, may be a causal link with a simultaneously taking place in Vienna Phase I study of an H5N1 vaccine live in the Austrian pharmaceutical company Baxter, in which as a "nasal spray" designed bird flu vaccine tested on humans. Whether the contamination of the vaccines actually in human phase I study in Vienna effect is unclear, but it would plausible to explain why at 11.02. Five days after a laboratory accident by contaminated vaccine in the Czech Republic - Austria Vienna in 18 people in the Otto-Wagner-Spital preventively against H5N1 should be treated."


From the above, it can be speculated that the vaccines sent to Czech R. and Slovenia were not human live nasal AH3N2 seasonal vaccine (after checked on animals),
but human live nasal AH5N1 avian flu vaccine.

From the above speculation it can be spec. further (all signed with an (?)):

Possibility 1. - there is no previous mandatory laboratory input checking of the genuinity of the received human/animal vaccines by the recipient laboratories/countries (reasons - the failured/contaminated/or wrong labeled vaccines passed)

Possibility 2. - the checkings from point 1. exists, but because of lab tecnology lacks it can't be checked enaugh well to appurate the contained viral strain of such vaccines

Possibility 3. In both the cases (point 1. or 2.), the failured vaccines were totaly diferent AH5N1, but labeled as AH3N2.
In that case it was an grassroot error/... of switching sprays/labels.

Possibility 4. The failured vaccines were AH3N2 mixed with parts of AH5N1, so it was dificult to locate it by lab checks.
In that case it was an error of switching/mixing vaccine fluids - it means that at the source lab stays together in the worklab avian flu viruses human fluids/vaccines and seasonal flu human fluieds/vaccines, which is not enaugh secure.


In any case, the guidelines for handling infectious agent materials must be changed, so such errors can't happens any more, no matter the reason.
 
Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Baxter?s Vaccine Research Sent Bird Flu Across European Labs - Bloomberg.com: Science

Baxter?s Vaccine Research Sent Bird Flu Across European Labs

By Michelle Fay Cortez and Jason Gale
Feb. 24 (Bloomberg) --

Researchers from Baxter International Inc. in Austria unintentionally sent samples contaminated with the bird flu virus to laboratories in the Czech Republic, Slovenia and Germany, raising concern about the potential spread of the deadly disease.


The contamination was discovered after ferrets were injected with the vaccine, according to BioTest s.r.o, a biotechnology company based in Konarovice that was working with the immunization in the Czech Republic.

The vaccine came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a spokeswoman for the ministry, said in a telephone interview today. The vaccine was prepared for use in laboratories, and none of the workers exposed have fallen ill.

?This was infected with a bird flu virus,? Rosenberger said. ?There were some people from the company who handled it. They went to the hospital and were tested and were cleared. There have been no infections.?

The Austrian health ministry reported the incident to the European Union and plans to conduct its own audit, she said. The vaccine has been destroyed, according to Rosenberger.

Chris Bona and Laura Grossmann, Baxter spokespeople, didn?t immediately return phone calls placed before business hours. Roland Bettschart, who handles media enquiries for Baxter in Vienna, said a ?laboratory glitch? occurred and the company would send a formal statement soon.

The World Health Organization ?is aware of the situation and is consulting with the ministers of health of the countries involved to ensure that all public risks arising from this event have been identified and managed appropriately,? said Gregory Hartl, a spokesman in Geneva.

The European Medicines Agency has no immediate comment, said Monika Benstetter, an agency spokeswoman.

Flu Pandemic
The H5N1 strain of avian flu has been monitored by health officials around the world for more than a decade for signs it could mutate into a form that is easily spread between humans. Currently, it passes mainly between infected poultry.

A flu pandemic of avian or other origin could kill more than 70 million people worldwide and lead to a ?major global recession? costing more than $3 trillion, according to a worst-case scenario outlined by the World Bank in October.

H5N1 has infected at least 406 people in 15 countries since 2003, killing 63 percent of them, according to the Web site of the Geneva-based WHO.

Baxter, the world?s largest maker of blood-disease treatments, is one of the companies working on a vaccine to be used in the event of a flu pandemic. The European Medicines Agency recommended approval of Baxter?s Celvapan, the first cell culture-based vaccine for bird flu in Europe, in December.

Lab Escape
BioTest, which conducts research for Baxter, was ?supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus,? the company said in a statement last week. ?If there had not been a mistake on the part of the supplier, the bird flu virus would not get into the Czech Republic in this way.?

Three influenza pandemics, including the 1918 Spanish flu that killed more than 50 million people, occurred since 1900.

Another three pandemic threats -- situations where a global epidemic is close to occurring -- have taken place. One of them, the Russian flu of 1977, is thought to have been caused by the virus escaping from a lab, according to an article on influenza pandemics published in the Scottish Medical Journal in February 2008.

The H5N1 virus, ?even if it were let out of the lab, would be only lethal for birds in its present state,? said Ilaria Capua, a veterinary virologist, whose laboratory in Padova, Italy, handles some of the avian-flu screening for the World Organization for Animal Health. Capua said she has no knowledge of the situation. ?In Europe, we can react fast? to outbreaks of the disease in animals, she said.

To contact the reporters on this story:
Michelle Fay Cortez in London at mcortez@bloomberg.net
Jason Gale in Singapore at j.gale@bloomberg.net
Last Updated: February 24, 2009 09:28 EST
-
<cite cite="http://www.bloomberg.com/apps/news?pid=20601124&sid=aiqmSoL6sVbk&refer=home">Bloomberg.com: Science</cite>
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Baxter Sent Bird Flu Virus to European Labs by Error (Update1) - Bloomberg.com: News

Baxter Sent Bird Flu Virus to European Labs by Error (Update1)

By Michelle Fay Cortez and Jason Gale
Feb. 24 (Bloomberg) --

Baxter International Inc. in Austria unintentionally contaminated samples with the bird flu virus that were used in laboratories in three neighboring countries, raising concern about the potential spread of the deadly disease.


The contamination was discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples in early February. The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said over the telephone today.

?This was infected with a bird flu virus,? Rosenberger said. ?There were some people from the company who handled it.?

The material was intended for use in laboratories, and none of the lab workers have fallen ill.

The incident is drawing scrutiny over the safety of research using the H5N1 bird flu strain that?s killed more than three-fifths of the people known to have caught the bug worldwide. Some scientists say the 1977 Russian flu, the most recent global outbreak, began when a virus escaped from a laboratory.

The virus material was supposed to contain a seasonal flu virus and was contaminated after ?human error,? said Christopher Bona, a spokesman for Baxter, in a telephone interview.

Baxter ?moved very quickly to sanitize and protect employees,? Bona said. ?Labs have been sanitized, potentially contaminated materials have been destroyed and employees were tested and considered not to be at risk.?

?Human Error?
The Austrian health ministry reported the incident to the European Union and is conducting its own audit, Rosenberger said. In response, Baxter said it has put in place ?preventive and corrective? measures that the ministry found satisfactory. The vaccine has been destroyed, according to Rosenberger.

The World Health Organization ?is aware of the situation and is consulting with the ministers of health of the countries involved to ensure that all public risks arising from this event have been identified and managed appropriately,? said Gregory Hartl, a spokesman in Geneva.

The European Medicines Agency has no immediate comment, said Monika Benstetter, an agency spokeswoman.

The H5N1 strain of avian flu has been monitored by health officials around the world for more than a decade for signs it could mutate into a form that is easily spread between humans. Currently, it passes mainly between infected poultry.

A flu pandemic of avian or other origin could kill more than 70 million people worldwide and lead to a ?major global recession? costing more than $3 trillion, according to a worst- case scenario outlined by the World Bank in October.

H5N1 has infected at least 408 people in 15 countries since 2003, killing 63 percent of them, according to the Web site of the Geneva-based WHO.

Flu Pandemic
BioTest s.r.o, a Czech biotechnology company, was conducting research for a company called AVIR Green Hill Biotechnology using materials supplied by Baxter. The company was ?supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus,? BioTest said in a statement last week.

Birgit Kofler-Bettschart, a spokeswoman for AVIR Green Hills, declined to comment immediately by telephone.

Three influenza pandemics, including the 1918 Spanish flu that killed more than 50 million people, occurred since 1900.

Another three pandemic threats -- situations where a global epidemic is close to occurring -- have taken place. One of them, the Russian flu of 1977, is thought to have been caused by the virus escaping from a lab, according to an article on influenza pandemics published in the Scottish Medical Journal in February 2008.

The H5N1 virus, ?even if it were let out of the lab, would be only lethal for birds in its present state,? said Ilaria Capua, a veterinary virologist, whose laboratory in Padova, Italy, handles some of the avian-flu screening for the World Organization for Animal Health. Capua said she has no knowledge of the situation. ?In Europe, we can react fast? to outbreaks of the disease in animals, she said.

Baxter, the world?s largest maker of blood-disease treatments, is one of the companies working on a vaccine to be used in the event of a flu pandemic. The European Medicines Agency recommended approval of Baxter?s Celvapan, the first cell culture-based vaccine for bird flu in Europe, in December.

To contact the reporters on this story:
Michelle Fay Cortez in London at mcortez@bloomberg.net
Jason Gale in Singapore at j.gale@bloomberg.net
Last Updated: February 24, 2009 12:48 EST
-
<cite cite="http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aG31xTtXom00">Bloomberg.com: News</cite>
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

The checking questions, points 1. and 2. from #33, remains.

The formulation of "was supposed to get ..." is an not enaugh good security policy when we speak of viruses delivery.

Should we have it transported through postal service as ordinary items (as the news reported cases with bact. plague/...) and having another lab failure pandemic (as '77, here #34 wroted to be), or it must be an stringent no-impurity quality lab input and lab output control branch?

With all my respect to the researchers, and the Dr.vir. I.C., it is visible (if the text #34 is exact) that not all of the major sci. officials were informed in real time about this potential virus spread situation, now note to went also in Germany.

Additionaly, if the event was right reported, even if the contamination virus was not an lab.eng. human avian AH5N1 strain but an avian one, it is yet not clear here if the supposed tested human seasonal flu virus AH3N2 was present into the spray also, or not.

If it does, it means that the mixing liquid wasn't an animal only virus danger, but an perfect oportunity of creating an human/avian flu mixing vector spreading.
What if into the spray was the here cited (#10) already existed lab mix of an human AH3N2 with an AH5N1 virus?

Even if the above wasn't the case, and the spray was an avian flu only, the next time we could be less lucky, and the agent could be realy mixed.

We need not to monitor any natural pandemic agent realy, humans "would create this oportunity" ... :rolleyes:

The irony is to got such tampering case short after the cited recommended approval of bf vacc. in dec.


The above comments are spec. based on infos from the thread texts and the posted Bloomberg Iron. text here in post #34:

"... The European Medicines Agency recommended approval of Baxter’s Celvapan, the first cell culture-based vaccine for bird flu in Europe, in December.
Lab Escape
BioTest, which conducts research for Baxter, was “supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus,” the company said in a statement last week. “If there had not been a mistake on the part of the supplier, the bird flu virus would not get into the Czech Republic in this way.”
...
One of them, the Russian flu of 1977, is thought to have been caused by the virus escaping from a lab, according to an article on influenza pandemics published in the Scottish Medical Journal in February 2008.

The H5N1 virus, “even if it were let out of the lab, would be only lethal for birds in its present state,” said Ilaria Capua, a veterinary virologist, whose laboratory in Padova, Italy, handles some of the avian-flu screening for the World Organization for Animal Health. Capua said she has no knowledge of the situation.In Europe, we can react fast” to outbreaks of the disease in animals, she said."
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Baxter Sent Bird Flu Virus to European Labs by Error (Update2) - Bloomberg.com: News
Baxter Sent Bird Flu Virus to European Labs by Error (Update2)

By Michelle Fay Cortez and Jason Gale
Feb. 24 (Bloomberg) --

Baxter International Inc. in Austria unintentionally contaminated samples with the bird flu virus that were used in laboratories in three neighboring countries, raising concern about the potential spread of the deadly disease.


The contamination was discovered when ferrets at a laboratory in the Czech Republic died after being inoculated with vaccine made from the samples early this month. The material came from Deerfield, Illinois-based Baxter, which reported the incident to the Austrian Ministry of Health, Sigrid Rosenberger, a ministry spokeswoman, said today in a telephone interview.

“This was infected with a bird flu virus,” Rosenberger said. “There were some people from the company who handled it.”

The material was intended for use in laboratories, and none of the lab workers have fallen ill.

The incident is drawing scrutiny over the safety of research using the H5N1 bird flu strain that’s killed more than three-fifths of the people known to have caught the bug worldwide. Some scientists say the 1977 Russian flu, the most recent global outbreak, began when a virus escaped from a laboratory.

The virus material was supposed to contain a seasonal flu virus and was contaminated after “human error,” said Christopher Bona, a spokesman for Baxter, in a telephone interview.

‘Sanitized’
Baxter “moved very quickly to sanitize and protect employees,” Bona said. “Labs have been sanitized, potentially contaminated materials have been destroyed and employees were tested and considered not to be at risk.”

Baxter gained 93 cents, or 1.6 percent, to $58.27 at 4 p.m. in New York Stock Exchange composite trading, and has lost 2.3 percent over the last 12 months.

The Austrian health ministry reported the incident to the European Union and is conducting its own audit, Rosenberger said. In response, Baxter said it has put in place “preventive and corrective” measures that the ministry found satisfactory. The vaccine has been destroyed, according to Rosenberger.

The World Health Organization “is aware of the situation and is consulting with the ministers of health of the countries involved to ensure that all public risks arising from this event have been identified and managed appropriately,” said Gregory Hartl, a spokesman in Geneva.

European Agencies
The European Medicines Agency has no immediate comment, said Monika Benstetter, an agency spokeswoman. The U.S. Centers for Disease Control and Prevention, which distributes seasonal flu viruses to companies for vaccine manufacturing, isn’t investigating or providing consultation, said Tom Skinner, a spokesman for the Atlanta-based agency. The CDC is staying in touch with the European Centre for Disease Prevention and Control regarding the incident, Skinner said.

The H5N1 strain of avian flu has been monitored by health officials around the world for more than a decade for signs it could mutate into a form that is easily spread among humans. Currently, it passes mainly among infected poultry.

A flu pandemic of avian or other origin could kill more than 70 million people worldwide and lead to a “major global recession” costing more than $3 trillion, according to a worst- case scenario outlined by the World Bank in October.

H5N1 has infected at least 408 people in 15 countries since 2003, killing 63 percent of them, according to the Web site of the Geneva-based WHO.

Flu Pandemic
BioTest s.r.o, a Czech biotechnology company, was conducting research for a company called AVIR Green Hills Biotechnology using materials supplied by Baxter. The company was “supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus,” BioTest said in a statement last week.

AVIR Green Hills monitored its lab workers for signs of illness and got access to Roche Holding AG’s Tamiflu antiviral in case of infections, said Birgit Kofler-Bettschart, a spokeswoman for the closely held, Vienna-based company. AVIR Green Hills sanitized its laboratories, destroyed potentially contaminated samples, and told health officials, she said in an e-mail today.

Three influenza pandemics, including the 1918 Spanish flu that killed more than 50 million people, have occurred since 1900.

Threats
Another three pandemic threats -- situations where a global epidemic is close to occurring -- have occurred. One was the Russian flu of 1977.

The H5N1 virus, “even if it were let out of the lab, would be only lethal for birds in its present state,” said Ilaria Capua, a veterinary virologist, whose laboratory in Padova, Italy, handles some of the avian-flu screening for the World Organization for Animal Health. Capua said she has no knowledge of the situation. “In Europe, we can react fast” to outbreaks of the disease in animals, she said.

Baxter, the world’s largest maker of blood-disease treatments, is one of the companies working on a vaccine to be used in case of a flu pandemic. The European Medicines Agency recommended approval of Baxter’s Celvapan, the first cell culture-based vaccine for bird flu in Europe, in December.

To contact the reporters on this story:
Michelle Fay Cortez in London at mcortez@bloomberg.net
Jason Gale in Singapore at j.gale@bloomberg.net
Last Updated: February 24, 2009 16:20 EST
-
<cite cite="http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTo3LbhcA75I">Bloomberg.com: News</cite>
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

From post text #37:

"The virus material was supposed to contain a seasonal flu virus ..." ...

"The U.S. Centers for Disease Control and Prevention, which distributes seasonal flu viruses to companies for vaccine manufacturing, isn’t investigating or providing consultation ..."
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

The Canadian Press: Officials investigate how bird flu viruses were sent to unsuspecting labs

Officials investigate how bird flu viruses were sent to unsuspecting labs

Officials are trying to get to the bottom of how vaccine manufacturer Baxter International Inc. made "experimental virus material" based on a human flu strain but contaminated with the H5N1 avian flu virus and then distributed it to an Austrian company.


That company, Avir Green Hills Biotechnology, then disseminated the supposed H3N2 virus product to subcontractors in the Czech Republic, Slovenia and Germany.

Authorities in the four European countries are looking into the incident, and their efforts are being closely watched by the World Health Organization and the European Centre for Disease Control.

Though it appears none of the 36 or 37 people who were exposed to the contaminated product became infected, the incident is being described as "a serious error" on the part of Baxter, which is on the brink of securing a European licence for an H5N1 vaccine.

That vaccine is made at a different facility, in the Czech Republic.

"For this particular incident ... the horse did not get out (of the barn)," Dr. Angus Nicoll of the ECDC said from Stockholm.

"But that doesn't mean that we and WHO and the European Commission and the others aren't taking it as seriously as you would any laboratory accident with dangerous pathogens - which you have here."

Accidental release of a mixture of live H5N1 and H3N2 viruses - if that indeed happened - could have resulted in dire consequences. Nicoll said officials still aren't 100 per cent sure the mixture contained live H5N1 viruses. But given that ferrets exposed to the mixture died, it likely did.

H5N1 doesn't easily infect people, but H3N2 viruses do. They are one of two types of influenza A viruses that infect people each flu season.

If someone exposed to the mixture had been co-infected with H5N1 and H3N2, the person 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.

Research published last summer by scientists at the U.S. Centers for Disease Control found that in the laboratory, H5N1 and H3N2 viruses mated readily. While less virulent than H5N1, a number of the offspring viruses appeared to retain at least a portion of the killing power of their dangerous parent.

Baxter International, which is based in Deerfield, Ill., said the contamination was the result of an error in its research facility in Orth-Donau, Austria.

The facility had been contracted by Avir Green Hills to make what Baxter refers to as "experimental virus material" based on human H3N2 viruses.

Christopher Bona, Baxter's director of global bioscience communications, said the liquid virus product was not a vaccine and was developed for testing purposes only. He deferred questions about the purpose of the testing to Avir Green Hills, but said the batch was to be used in animals and was never intended for use in humans.

Avir Green Hills said in an email that it took possession of the material in late December. It later sent the product to the sub-contractors. The email said the material was stored and handled throughout under high biosafety conditions.

Alarm bells rang in early February when researchers at the Czech sub-contractor inoculated ferrets with the material and the animals promptly died. Baxter learned about the problem on Feb. 6, Bona said from Deerfield.

Ferrets are susceptible to human flu strains, but they don't die from those infections. Preliminary investigation found the material was contaminated with H5N1 flu virus, which is lethal to ferrets.

Nicoll said the fact the ferrets died supports the working assumption that there were live H5N1 viruses in the material Baxter produced.

Bona said Baxter has identified how the contamination happened and has taken steps to ensure it doesn't happen again. He said Austrian authorities audited Baxter's Orth-Donau research operations after the problem came to light and are satisfied with the steps taken.

Baxter is the only flu vaccine manufacturer to work with wild type flu viruses, felt to be more dangerous than the altered and attenuated (weakened) viruses other manufacturers use.

The company uses what is known as BSL3 level precautions in all its vaccine research facilities, Bona said. (Researchers at the U.S. CDC use BSL3-plus biocontainment when working with H5N1 viruses, a spokesperson for the agency said.)

People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses have somehow co-mingled in the Baxter research facility. That should not be allowed to happen, a number of experts insisted.


The company isn't shedding much light on how it did.

"It was a combination of just the process itself, (and) technical and human error in this procedure," Bona said. When asked to elaborate, he said to do so would give away proprietary information about Baxter's production process.

Bona said when Baxter realized its error, it helped the various companies destroy the contaminated material and clean up their facilities. And staff who had been exposed to the contaminated product were assessed and monitored by infectious diseases doctors. They were also offered the antiviral drug oseltamivir (Tamiflu).

Baxter's error is reminiscent of a 2005 incident where a U.S. manufacturer of kits used by laboratories to test their detection capabilities included vials of H2N2 virus in several thousand proficiency kits. H2N2, the virus that caused the 1957 pandemic, has not circulated since 1968 and is thought to be a prime candidate to cause the next pandemic.

That mistake, discovered by Canada's National Microbiology Laboratory, set authorities around the world scrambling to retrieve and destroy the vials of virus, which had been sent to labs in 18 countries.
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<cite cite="http://www.google.com/hostednews/canadianpress/article/ALeqM5jJ4CmDnp1pP1ZqHShBeayzTuzsEA">The Canadian Press: Officials investigate how bird flu viruses were sent to unsuspecting labs</cite>
 
Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Thank You very much Ironorehopper for the posted Canadian Press text #39.

#39:
"Research published last summer by scientists at the U.S. Centers for Disease Control found that in the laboratory, H5N1 and H3N2 viruses mated readily. While less virulent than H5N1, a number of the offspring viruses appeared to retain at least a portion of the killing power of their dangerous parent."


After two big biosecurity international breaches in a few years period, maybe B. would change the tec. and leave the live virus outside production, as the others did ...
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#39:
"the contamination was the result of an error in its research facility in Orth-Donau, Austria"

"People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses have somehow co-mingled in the Baxter research facility. That should not be allowed to happen, a number of experts insisted."

"Baxter's error is reminiscent of a 2005 incident where a U.S. manufacturer of kits used by laboratories to test their detection capabilities included vials of H2N2 virus in several thousand proficiency kits. H2N2, the virus that caused the 1957 pandemic, has not circulated since 1968 and is thought to be a prime candidate to cause the next pandemic.

That mistake, discovered by Canada's National Microbiology Laboratory, set authorities around the world scrambling to retrieve and destroy the vials of virus, which had been sent to labs in 18 countries."
_____

"Baxter is the only flu vaccine manufacturer to work with wild type flu viruses, felt to be more dangerous than the altered and attenuated (weakened) viruses other manufacturers use."

#39:
"contracted by Avir Green Hills to make what Baxter refers to as "experimental virus material" based on human H3N2 viruses.

"If someone exposed to the mixture had been co-infected with H5N1 and H3N2, the person 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."
 
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