Baxter?s Vaccine Research Sent Bird Flu Across European Labs

[Giuseppe]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

LifeGen.de - Exclusive Interview: Baxter explaining what really happened with H5N1 samples in Europe

Exclusive Interview: Baxter explaining what really happened with H5N1 samples in Europe

Since we started our coverage of the Baxter-Contamination Story in Europe shares of the big pharmaceutical company in Deerfield, IL have lost more more than 8 percent in two days, as a look at Google Finance reveals.


Baxter's Chief of Communications in the US, Christopher Bona, supported our idea for an exclusive interview, so Jutta Brenn-Vogt, Manager Communications at Baxter Deutschland GmbH explained LifeGen.de what really happened with H5N1, and how security measures - not only at Baxter - should work on a global scale.

LifeGen.de:
How and when did Baxter find out about the contamination?

Brenn-Vogt:
A suspicion concerning a potential contamination arose at AVIR Greenhills' contracted lab in the Czech Republic during the late afternoon of Friday, February 6. Baxter was then notified by AVIR Greenhills about this situation in three locations (Slovenia, Czech Republic, Austria) during the early evening of Friday, February 6. The last notification was on February 17 from AVIR Greenhills regarding a laboratory in Germany.

LifeGen.de:
Promed mentions H5N1 and/or H3N2 as contaminants. Could you describe us what exactly happened to the charges?

Brenn-Vogt:
Firstly, the material that was contaminated with H5N1 was not a vaccine, but was an experimental virus material. The impacted material was made at Baxter?s facility in Orth, Austria. It was produced exclusively for laboratory testing for AVIR Greenhills. It was not used for product production or for use in humans. The root cause of the incident has been identified. It was due to a unique combination of process, technical and human error in a procedure used for this specific research project in our facility in Austria (Orth). The chances of such a confluence of events repeating itself are virtually impossible. 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 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. The employees who may have been exposed to this material have gone through a specific examination by infectious disease specialists. These people were tested or considered by disease specialists not to be at risk. The results of all performed tests were negative.

LifeGen.de:
Baxter is handling H5N1 in BSL3 labs. Where is the security lack of the system? In other words: How could the charges get in European 4 countries without intention?

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:
Do you think smaller companies like Avir Green Hills Biotechnology should handle Baxter's charges?

Brenn-Vogt:
Baxter is contracted to provide influenza virus material to AVIR Greenhills for that company's use in developing their influenza vaccine. In this case, Baxter produced one component of the influenza vaccine. The individuals working with the experimental material were operating in laboratory containment conditions specifically designed to prevent exposure. We see no need to speculate on how the size of a lab had bearing on this incident.

LifeGen.de:
After the Antrhrax 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.

questions by Vlad Georgescu

About LifeGen.de:
The special interest online-magazine LifeGen.de reaches more than 90.000 unique users coming from 146 countries worldwide. The magazine is read by the scientific community, by members of political institutions and by major public media. LifeGen.de was founded in 2001 an is considered to be one of Europes most important lifescience Online-Magazines. More than 7100 articles can be found at the German Business Information

(GENIOS)(2009-03-02)
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<cite cite="http://www.lifegen.de/newsip/shownews.php4?getnews=2009-03-02-2412&pc=s02">LifeGen.de - Exclusive Interview: Baxter explaining what really happened with H5N1 samples in Europe</cite>

 

[sharon sanders]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

This thread is for news, interviews, and other data regarding this issue.

Please post further discussion here.

 

[Giuseppe]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

[WARNING: Google RAW Machine Translation from Norwegian to English. Please do refer to original article at this link: http://www.nrk.no/programmer/tv/puls/1.6515693 - The Norwegian language portion is also available below. IOH.]

Then attempt the animals died after injections of the new flu vaccine, made a laboratory in the Czech Republic suspect that something was wrong.

Further investigations showed that the vaccine not only of common influensavirus, but also live avian flu virus, the The Canadian Press.

The trial vaccine was developed in the vaccine manufacturer Baxter Laboratory in Orth-Donau, Austria. Vaccine was then delivered to an Austrian company who in turn sent portions to subcontractors in the Czech Republic, Slovenia and Germany. Tabber is investigated in all four countries.
Should not be able to happen

Bird flu virus is feared because the researchers believe it may evolve into a pandemic. But when the virus must develop skills that will facilitate the transmission from human to human.

One way it can happen on, is that a person infected by both the regular flu and avian flu at the same time, genetic, and from the two viruses mixed. So it's very strict rules for the retention of avian flu virus.

- Avian Flu virus and normal seasonal influensavirus will not be at the same laboratory during vaccine production, "said senior adviser Randi Winsnes in the pharmaceutical plant.

She stresses that she does not know of this matter and therefore only pronounce itself on a general basis.

- Control work

Executive Director Hanne N?kleby by Folkehelseinstituttet certify the matter to the BBC, but is concerned that the error was discovered in time.

- It is true that there was live avian flu virus in the vaccine trials. But it was an experimental vaccine, and it was stopped in time. It is important to say that the control has functioned as they should, "she says.

Vaccine has not been tested on humans, and the employees at the lab will closely follow-up.

Baxter has not produced any of the influenza vaccine that has Folkehelseinstituttet distributed in Norway.
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[NORWEGIAN]

Da fors?ksdyrene d?de etter injeksjoner av den nye influensavaksinen, fattet et laboratorium i Tsjekkia mistanke om at noe var galt.

N?rmere unders?kelser viste at vaksinen ikke bare inneholdt vanlige influensavirus, men ogs? levende fugleinfluensavirus, melder The Canadian Press.

Pr?vevaksinen ble utviklet i vaksineprodusenten Baxters laboratorium i Orth-Donau i ?sterrike. Vaksinen ble s? levert til et ?sterriksk firma som igjen sendte porsjoner til underleverand?rer i Tsjekkia, Slovenia og Tyskland. Tabben blir etterforsket i alle fire landene.
Skal ikke kunne skje

Fugleinfluensaviruset er fryktet fordi forskerne tror det kan utvikle seg til en pandemi. Men da m? viruset utvikle egenskaper som gj?r at det kan smitte fra menneske til menneske.

En m?te det kan skje p?, er at et menneske smittes av b?de vanlig influensa og fugleinfluensa samtidig, og arvestoff fra de to virusene blandes. Derfor er det sv?rt strenge regler for oppbevaring av fugleinfluensavirus.

- Fugleinfluensavirus og vanlig sesonginfluensavirus skal ikke befinne seg p? samme laboratorium under vaksineproduksjon, sier seniorr?dgiver Randi Winsnes i legemiddelverket.

Hun presiserer at hun ikke kjenner til denne saken og derfor bare uttaler seg p? generelt grunnlag.
- Kontrollrutinene fungerte

Divisjonsdirekt?r Hanne N?kleby ved Folkehelseinstituttet bekrefter saken overfor NRK, men er opptatt av at feilen ble oppdaget i tide.

- Det stemmer at det var levende fugleinfluensavirus i denne fors?ksvaksinen. Men det var en fors?ksvaksine, og den ble stoppet i tide. Det er viktig ? si at kontrollrutinene har fungert slik de skulle, sier hun.

Vaksinen har ikke v?rt pr?vd ut p? mennesker, og de ansatte ved laboratoriet f?r n?ye oppf?lging.

Baxter har ikke produsert noen av influensavaksinene som Folkehelseinstituttet har distribuert i Norge.
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[Giuseppe]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

FT.com - WHO mulls stricter transport of bio products

WHO mulls stricter transport of bio products

By Andrew Jack
Published: March 16 2009 22:10 | Last updated: March 16 2009 22:10

Public health officials are studying the need for tighter controls on the transport of biological products after Baxter, the US pharmaceutical company, inadvertently supplied samples of the H5N1 bird flu virus to a series of European laboratories.


Specialists from the World Health Organisation and the European Centre for Disease Prevention and Control are monitoring the case at a time of growing concern that existing international rules to minimise the risks of the spread of pathogens are too weak.

Their scrutiny follows an incident that recently came to light when samples of H5N1 from Baxter?s Austrian labs contaminated batches of the less harmful H3N2 seasonal flu virus that it was supplying under a commercial contract to a customer, Avir Greenhills Biotechnology.

A combination of H3N2, which is highly transmissable between humans, and H5N1, which has killed hundreds of millions of chickens and other animals in recent years, could potentially lead to a mutated virus that forms the basis of a new human pandemic threatening millions of lives, according to scientists.

Baxter stressed that the H3N2 strain had been made ?replication defective?, and was handled in tightly controlled laboratories purely for experiments, so there was little chance it could have led to an outbreak threatening humans. It also stressed that all staff potentially exposed were tested and given antiviral treatment to prevent any infection.

Baxter was forced to suspend production last year of Heparin, a blood thinner, after contamination during manufacturing of the primary ingredient in China triggered health alerts in the US, where regulators say it may have contributed to patient deaths. Baxter has refuted the FDA?s claim.

Baxter said the H5N1 samples were provided for its own research into a pandemic vaccine it is developing, and were from a variant of the virus identified in Vietnam and provided to the company by the US Centers for Disease Control in Atlanta.

?The material was handled appropriately in all steps of the process in the right conditions,? said Chris Bona, a Baxter spokesman. ?The experimental material was produced exclusively for laboratory testing, was not used for product production and was not for use in humans.?

It somehow mixed with H3N2 before distribution last December to Avir, and the more potent virus was detected by a subcontractor in the Czech republic last month after it rapidly killed ferrets exposed to the viruses. Avir had also sent samples to Slovenia and Germany.

Mr Bona stressed that Baxter had since taken ?corrective preventative actions? and its procedures had been approved by the Austrian authorities.

The incident comes just after the conclusion of an EU-funded project on biosafety highlighted the need for improvement to national regulatory frameworks for biosafety and laboratory biosecurity.
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<cite cite="http://www.ft.com/cms/s/0/d7a3e3d6-1237-11de-b816-0000779fd2ac.html?nclick_check=1">FT.com / Companies / Pharmaceuticals - WHO mulls stricter transport of bio products</cite>

 

[tropical]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Ironorehopper #64 post news:
"...
growing concern that existing international rules to minimise the risks of the spread of pathogens are too weak.
...
The incident comes just after the conclusion of an EU-funded project on biosafety highlighted the need for improvement to national regulatory frameworks for biosafety and laboratory biosecurity.
...
Public health officials are studying the need for tighter controls on the transport of biological products ... "


:applause::applause:

 

[JJackson]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

I note in the FT article the H3N2 is described as 'replication defective' and in an email reply to some specific question I put to Baxter I got 'The chances of reassortment occurring are considerably lower than could occur in nature as the H3N2 virus was a replication-defective H3N2 virus.'

From what I understand to have been going on the the Biotest ferrets had been vaccinated and were to be challenged with H3N2. The bit that is confusing me is why would you use an H3N2 that could not replicate as well as wild type to test if a vaccine worked? Would this not just give less useful results?

If anyone can explain this I would be most grateful.

Edit:
What I forgot to mention was I had also asked if the H3N2 and the H5N1 were both live viruses and got yes to both. I had assumed the point of using non-replicating virus was so you could test the antibody response to a fixed amount of antigen but then why bother with a live virus at all? In terms of the flu virus what does 'replication impaired' mean?

 

[HenryN]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

AVIAN INFLUENZA, ACCIDENTAL DISTRIBUTION - CZECH REPUBLIC ex AUSTRIA (03)
*************************************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

Date: Mon 16 Mar 2009
Source: The Financial Times online [edited]
<http://www.ft.com/cms/s/0/d7a3e3d6-1237-11de-b816-0000779fd2ac.html>


WHO mulls stricter transport of bio products
--------------------------------------------
Public health officials are studying the need for tighter controls on
the transport of biological products after Baxter, the US
pharmaceutical company, inadvertently supplied samples of the H5N1
bird flu virus to a series of European laboratories. Specialists from
the World Health Organisation (WHO) and the European Centre for
Disease Prevention and Control (ECDC) are monitoring the case at a
time of growing concern that existing international rules to minimise
the risks of the spread of pathogens are too weak.

Their scrutiny follows an incident that recently came to light when
samples of H5N1 from Baxter's Austrian labs contaminated batches of
the less harmful H3N2 seasonal flu virus that it was supplying under
a commercial contract to a customer, Avir Greenhills Biotechnology.

A combination of H3N2, which is highly transmissible between humans,
and H5N1, which has killed hundreds of millions of chickens and other
[birds] in recent years, could potentially lead to a mutated virus
that forms the basis of a new human pandemic threatening millions of
lives, according to scientists. Baxter stressed that the H3N2 strain
had been made replication-defective, and was handled in tightly
controlled laboratories purely for experiments, so there was little
chance it could have led to outbreak threatening humans. It also
stressed that all staff potentially exposed were tested and given
antiviral treatment to prevent any infection.

Baxter said the H5N1 samples were provided for its own research into
a pandemic vaccine it is developing, and were from a variant of the
virus identified in Viet Nam and provided to the company by the US
Centers for Disease Control in Atlanta. "The material was handled
appropriately in all steps of the process in the right conditions,"
said Chris Bona, a Baxter spokesman. The experimental material was
produced exclusively for laboratory testing, was not used for product
production and was not for use in humans. It somehow mixed with H3N2
before distribution last December [2008] to Avir, and the more potent
virus was detected by a subcontractor in the Czech Republic last
month [February 2009] after it rapidly killed ferrets exposed to the
viruses. Avir had also sent samples to Slovenia and Germany. Mr Bona
stressed that Baxter had since taken corrective preventative actions
and its procedures had been approved by the Austrian authorities.

The incident comes just after the conclusion of an EU-funded project
on biosafety highlighted the need for improvement to national
regulatory frameworks for biosafety and laboratory biosecurity.

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[Unfortunately there is no clarification of the basic error:
......."It [H5N1 virus] somehow mixed with H3N2 before distribution
last December [2008] to Avir". This thread is now cut. - Mod.CP]

[see also:
Avian influenza, accidental distribution - Czech Rep. ex Austria (02)
20090226.0801
Avian influenza, accidental distribution - Czech Rep. ex Austria: RFI
20090225.0776]
...................................cp/mj/dk

 

[HenryN]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

I note in the FT article the H3N2 is described as 'replication defective' and in an email reply to some specific question I put to Baxter I got 'The chances of reassortment occurring are considerably lower than could occur in nature as the H3N2 virus was a replication-defective H3N2 virus.'

From what I understand to have been going on the the Biotest ferrets had been vaccinated and were to be challenged with H3N2. The bit that is confusing me is why would you use an H3N2 that could not replicate as well as wild type to test if a vaccine worked? Would this not just give less useful results?

If anyone can explain this I would be most grateful.

Edit:
What I forgot to mention was I had also asked if the H3N2 and the H5N1 were both live viruses and got yes to both. I had assumed the point of using non-replicating virus was so you could test the antibody response to a fixed amount of antigen but then why bother with a live virus at all? In terms of the flu virus what does 'replication impaired' mean?

I suspect something was lost in translation going from reality to press release and the "replication defective" was related to the H5N1 and not the H3N2. H5N1 used in vaccine research has the polybasic cleavage site removed, so although the virus can replicate, it is "low path" instead of "high path" (polybasic cleavage site). It is low path so it can grow in chicken eggs and is not as risky for lab personnel handling the virus (or the general population in case of escape or lab error such as the Baxter fiasco.

My guess is the ferrets still died because they were given a high dose of H5N1 (instead of pure H3N2). The higher dose is used to make sure that the control animals all get sick, because a relatively small number of animals are used and if some of the controls did not get sick, the significance of the challenged group would be reduced.

The reassortment aspect has never made any sense because transmission is largerly controled by the H and swapping H3 for H5 would likely produce a virus that was not very dangerous (because humans have immunity to H3). Similarly, CDC reassortment experiments between human and avia flu did not prodice increased transmission. In fact most reassortant woulndn't grow in culture, or grew poorly in animals. None came close to H5N1 with 8 avian gene segments so there really isn't much compatability between H5N1 genes and seasonal flu, and the H3N2 genes would be much less comptable than H1N1.
Thus, the story got a lot of press, but most of the danger was limited to the ferrets (and some additional exposure to the lab workers).

 

[JJackson]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Thank you.

That would make sense but it is some way to get from attenuated H5N1 to replication deficient H3N2, which does not seem to be the kind of term an PR guy would come up with. The Orth plant seems to be the BSL3 lab for research and small scale production associated with their Verocell based products. Would this need to be attenuated for the vero cell line and I thought one of the selling points for Baxter was that, as well as being faster to scale up, the monkey cell line meant the engineering of the cleavage site could be skipped, so saving more time.

 

[HenryN]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Thank you.

That would make sense but it is some way to get from attenuated H5N1 to replication deficient H3N2, which does not seem to be the kind of term an PR guy would come up with. The Orth plant seems to be the BSL3 lab for research and small scale production associated with their Verocell based products. Would this need to be attenuated for the vero cell line and I thought one of the selling points for Baxter was that, as well as being faster to scale up, the monkey cell line meant the engineering of the cleavage site could be skipped, so saving more time.

I don't think the PR guy changed anything except for saying H3N2 instead of H5N1. I think the term "replication deficient" could be applied to H5N1 absent a cleavage site, because the polybasic cleavage site allows for replication outside of the respiratory tract, so an H5N1 without the polybasic cleavage site would be "replication deficient."

As far as Baxter vero cell advantage is concerneed, I agree that they don't need to remove the cleavage site to make a vaccine. However, the cleavage site is removed for two reasons. One is so the H5N1 doesn't kill the embryos in the eggs, which would not be an issue with vero (monkey) cells, but the other reason is safety, which would be an issue (and probbaly more so for Baxter now). For regulatory approval the safety is an even bigger issue because preclinical testing with live virus is required, and putting H5N1 with cleavage site in animals is an issue.

The regulatory apporval is really for the platform, and once approval is granted, new pre-clinical or clinical studies are not required when the target changes, so getting approval using the H5N1 that everyone else uses is not a problem for subsequently using an H5N1 with a polybasic cleavage site in times of crisis (after the pandemic has begun), is not an issue.

Thus, an H5N1 without a polybasic cleavage site can be use to gain approval, and then a new H5N1 with a polybasic cleavage site can be used for a future vaccine, since the virus is killed, and killing H5N1 with or without cleavage site is the same.

 

[JJackson]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Again Thanks. All of that sounds very plausible.

 

[gsgs]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

probably they examined the sequences of the ferret-viruses,
they know whether there were coinfection or even reassortment.

But they would not tell us or publish the sequences.
Well, maybe in some years.


> It was due to a unique combination of process, technical and human error in a procedure used
> for this specific research project in our facility in Austria (Orth).

> The chances of such a confluence of events repeating itself are virtually impossible

> All H5N1 infections that have been reported to date have been associated with direct
> exposure to infected poultry/birds

 

[HenryN]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Again Thanks. All of that sounds very plausible.

Maybe plausible, but WRONG.

It looks like the H3N2 was replication defective and the project is related to the program described here:

http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/projects/103_en.html

http://www.greenhillsbiotech.com/eu_projects.html

I suspect the vector was inadvertantly contaminated with H5N1.

 

[JJackson]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

The description in the first of those links ties up quite a few loose ends, well found.

While the antigenic sites of interest were from H5N1, as I understand the process, there is still no reason for the live H5N1 to be anywhere near the engineered H3N2. The H5N1 sequences would be added to the H3 and/or N2 RNA leading (along with any other modifications to insure it was apathogenic) to it prominently expressing the wanted epitopes. Again we are back to not wanting a replication impaired virus although again I suppose we could - at a stretch - call apathogenicity an imparement although, as it would not effect tissue tropism, it is nolonger a replication impairment.

 

[Giuseppe]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

European lab accidents raise biosecurity concerns - Reuters

European lab accidents raise biosecurity concerns

Thu Mar 19, 2009 1:39pm EDT
* Bird flu and Ebola virus accidents raise biosecurity fears
* European states urged to improve lab accident disclosure
* Northern Europe reports most lab-acquired infections

By Laura MacInnis and Debra Sherman
GENEVA/CHICAGO, March 19 (Reuters) -

Lab accidents involving bird flu and Ebola viruses have increased biosecurity fears in Europe, where public health experts say research on dangerous pathogens needs to be more strictly monitored.


A scientist in Germany last week pricked herself with a needle that was believed to be contaminated with a strain of the Ebola haemorrhagic virus with a mortality rate of around 90 percent. She is still under observation in hospital.

That accident added to public health concerns following the recent disclosure that deadly H5N1 bird flu virus samples were mixed with seasonal flu samples at a Baxter International (BAX.N) contracted laboratory in Austria.

Health authorities and industry groups reviewing European lab safety standards concluded in a new report that scientists and managers needed to be better trained in ways to prevent, handle and report such incidents.

While stressing that research on viruses and pathogens is important for vaccine, drug and diagnostic development, the group Biosafety Europe said "it also represents a risk to the population in case those organisms may spread in the environment due to a laboratory accident, poor laboratory practices or intentional removal and subsequent release (terrorist attack)."

"Adequate technical and physical containment measures and best biosafety and biosecurity practices must be implemented in those facilities to prevent accidental or intentional release of dangerous pathogens," it said in the recommendations, published on www.biosafety-europe.eu/FinalConsiderations_PDFs.html

Security experts say viruses and other biological agents could be used as weapons, as occurred in 2001 in the United States when envelopes containing anthrax were sent to media outlets and U.S. lawmakers, kiling five people.

HUMAN ERROR
Baxter spokesman Chris Bona said the Illinois-based company learned in February about the H5N1 contamination, which was due to "a combination of process, technical and human error."

The flu virus samples were meant only for testing and not vaccine or product development, according to the spokesman, who said Baxter has "put corrective measures in place" after the accident but declined to give details "for proprietary reasons."

All 37 people exposed to the mixture at subcontractor sites in Germany, the Czech Republic and Slovenia, and at AVIR Greenhills Biotechnology, an Austrian company that bought the samples, tested negative for H5N1 bird flu, Bona said.

The World Health Organisation (WHO) fears that virus, which has killed 256 people since 2003, could trigger a deadly flu pandemic if it mutates and starts to spread more easily.

Biosafety Europe's project coordinator Kathrin Summermatter said that better training and more collaboration on safety standards could help reduce pathogen risks in European labs.

"We found that even though there are European guidelines concerning biosafety, the awareness, the implementation and the control was not the same in the different European countries," she told Reuters by email.

The group's report, compiled before the recent bird flu and Ebola accidents, said that Northern European countries disclosed more laboratory-acquired infections than other parts of Europe, "which in part may reflect reporting differences."

Summermatter said greater transparency about incidents that do occur was essential to help identify and reduce risks: "It is important to learn from the experience of other laboratories."

(Editing by Mark Trevelyan)
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<cite cite="http://www.reuters.com/article/rbssHealthcareNews/idUSLJ55693920090319?sp=true">European lab accidents raise biosecurity concerns | Industries | Healthcare | Reuters</cite>

 

[tropical]

Re: Baxter?s Vaccine Research Sent Bird Flu Across European Labs

Quote:
<TABLE cellSpacing=0 cellPadding=6 width="100%" border=0><TBODY><TR><TD class=alt2 style="BORDER-RIGHT: 1px inset; BORDER-TOP: 1px inset; BORDER-LEFT: 1px inset; BORDER-BOTTOM: 1px inset">Originally Posted by JJackson
Again Thanks. All of that sounds very plausible.

</TD></TR></TBODY></TABLE>

Maybe plausible, but WRONG.

It looks like the H3N2 was replication defective and the project is related to the program described here:

http://ec.europa.eu/research/health/infectious-diseases/emerging-epidemics/projects/103_en.html

http://www.greenhillsbiotech.com/eu_projects.html

I suspect the vector was inadvertantly contaminated with H5N1.

Eh eh, ah, uh em

Previously wroted in post #10:
"I hope this thread cited case vacc. lab. technology wasn't the one which consist in taking one virus (adenovirus, other flu strain or other) and use it than as a vector for carrying the other virus particle, by the reason of faster vaccination somministration intended for the danger pose by the second virus ... "
<!-- / message -->

"Virus as a Vector For Foreign Antigens"

The CHIMERAS entering ...

____

From the post news #73 given first link:

"CHIMERIC VACCINES - Development of Influenza del NS1 Virus as a Vector For Foreign Antigens





<DL><DT>EC contribution <DD>: € 1 384 945 <DT>Duration <DD>: 30 months <DT>Starting date <DD>: 01/11/2004 <DT>Instrument <DD>: SMEs - Co-operative <DT>Keywords <DD>: Influenza, avian, vaccine, adjuvant, chimeric <DT>Project Number <DD>: COOP-CT-2004-512864 <DT>Web-site <DD>: www.greenhillsbiotech.com/eu_projects.html</DD></DL>
Summary:

The project CHIMERIC VACCINES is being carried out by an international consortium over a 30-month period. The consortium aims at developing a novel vaccine that will provide protection against avian influenza and seasonal influenza. The technical basis is a replication deficient influenza virus that was modified to express foreign antigens.
CHIMERIC VACCINES is led by the Austrian SME Green Hills Biotechnology and consists of three partner companies in Austria, Slovenia and the Czech Republic and two renowned university partners in Austria and Germany. In order to bring these vaccines to clinical use, one of the partners is the Russian WHO reference laboratory for influenza in St Petersburg, which has abundant experience in testing new vaccines.
Problem:

Avian influenza is an infectious disease of birds caused by type A strains of the influenza virus. The disease occurs worldwide. While all birds are thought to be susceptible to infection with avian influenza viruses, many wild bird species carry these viruses with no apparent signs of harm. A highly pathogenic form was first identified in Italy in 1878 and can lead to a mortality rate in infected animals of 100% within 48 hours.
Influenza viruses are species-specific and only rarely cause infection in other species. Since 1959, instances of human infection with an avian influenza virus have been documented on only 10 occasions. Of the hundreds of strains of avian influenza A viruses, only four are known to have caused human infections: H5N1, H7N3, H7N7 and H9N2. In general, human infection with these viruses has resulted in mild symptoms and very little severe illness, with one notable exception - the highly pathogenic H5N1 virus.
Currently, the H5N1 virus is of greatest significance as it has crossed the species barrier to infect humans on at least three occasions in recent years leading to the current outbreaks that began in December 2003. Currently, no vaccine against avian influenza is available.
Aim:

This consortium has developed a novel approach for vaccination against avian influenza. The technology is based on the insertion of selected epitopes into a genetically modified influenza virus that is apathogenic. To achieve these results, both a stable vector and promising antigens were identified. Antigen selection was based on bioinformatics methods that were substantiated by experimental validation. The properties of the backbone vector in terms of safety and stability were assessed in preclinical experiments and gave highly satisfactory results. To bring the proposed chimeric vaccine into clinical trials, a production process in small scale was established using a novel purification technology. Finally, preparations for a clinical trial in Russia were made by the Russian Institute of Influenza.
Expected results:

Results of this project will shed light on important aspects in the development of novel vaccination strategies and will help to further develop the concept of a chimeric vaccine. In addition, important information regarding immunogenicity and safety will be generated and a process for the production of purified viruses will be established.
Potential applications:

The vaccine developed in this project will be an important step towards a vaccine that can induce an immune response against foreign antigens of pathogens. The technologies that are used in this project will have the potential to be applied to other relevant pathogens as well.
Coordinator:

Joachim Seipelt Avir Green Hills Biotechnology AG Gersthofer Str 29-31
1180 Vienna Austria j.seipelt@greenhillsbiotech.com
Partners:

Emergentec Biodevelopment GmbH Rathausstrasse 5/3
1010 Vienna Austria BioTest Ltd Pod Zámkem 279
281 25 Konárovice Czech RepublicBIA Separations d.o.o. Teslova 30
1000 Ljubljana Slovenia Clinics of J W Goethe-University Paul-Ehrlich Str 40
60596 Frankfurt Germany Medical University, Vienna Dr Bohrgasse 9/3
1030 Vienna Austria State Institution Research Institute of Influenza Prof Popov Street 15/17
P. O. Box 197376
St Petersburg Russian Federation"