Baxter?s Vaccine Research Sent Bird Flu Across European Labs

[Gert van der Hoek]

Several Czechs threatened with bird flu - press

17 02 2009

Konarovice - Some Czechs were threatened by getting infected with the dangerous H5N1 bird flu virus strain from a vaccine developed by the Austrian pharmaceutical company Baxter that was tested on ferrets, the daily Mlada fronta Dnes (MfD) writes today.

The vaccine was tested by the Biotest company in Konarovice from early January and the research was permitted by the Industry and Trade Ministry, Czech chief sanitary officer Michael Vit told the paper.

"Suddenly the ferrets started dying and so the research stopped on February 6," Vit said.
The Czech veterinary authority revealed that the ferrets got infected with the lethal bird flu virus.

"All the ferrets had to be liquidated and the company had to be closed," said the authority's spokesman Josef Duben.

All 13 people who got into contact with the ferrets were in danger but they were lucky not to get infected, MfD writes.
"They immediately received the Tamiflu drug and they underwent tests. Fortunately, none of them got infected," Vit said.

However, Vit added that experts will continue to test these people.
Duben said the case was a "serious warning."

According to MfD, the Baxter company admitted that the mistake occurred in Austria and that it sent infected vaccines to the Czech Republic.

http://www.ceskenoviny.cz/news/zpravy/several-czechs-threatened-with-bird-flu-press/360802

 

[AlaskaDenise]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Continue to test after receiving tamiflu???

We know what that means - negative results.

.

 

[tropical]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Maybe they weren't sure if Tamiflu would work ...
especialy if it was administered late.

About this failure, it remembers me the last (?)year affair with the group of homeless persons.

Bad news indeed for prepand. vacc. priming without a pandemic starts.
Maybe it was a company error ("the company had to be closed"), compared with the other countries vacc.

 

[Giuseppe]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

One may assume that after a strict quarantine of exposed workers they should be safe... may be?

Incubation period should expire after two or three weeks, at least... Assuming that the virus in ferrets was same H5N1 we know... but it is also possible that it was a reassortant, or an hybrid, or live-attenuated... More informations clearly are needed.

 

[JJackson]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Links to BioTest and Baxter sites both of which are strangely silent on the issue. If - as the article implies - Baxter shipped live HPAI H5N1 to a non BSL3/4 lab and have narrowly escaped causing human infection this is a major story and they are dreaming if they think it will go away if they ignore it.

 

[Giuseppe]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

That points again of safety of viral samples manipulations and transportation...

 

[AlaskaDenise]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Baxter company admitted that the mistake occurred in Austria and that it sent infected vaccines to the Czech Republic.

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

.

 

[tropical]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

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

The situation is not enaugh clear.

As J.J. point, if indeed it was a live vaccine, and the job was conducted in an BSL2, that was an additional prove how such labworks must be done at BSL4, or at least at strenghtened 3 level facilities, as we pointed here at FT many times (and others elsewhere), but seems that it is not applyed in every country.

Second, there were other deadly episodes with chemical impurities in some products from that company brand, years ago.

As Denise said, "what realy happened"?

Even as possible, bypassing the vacc. production output control for such an experimental quantity doses of distributed vaccines seems an not very probably case.

From the Dutchy post #1:
"Some Czechs were threatened by getting infected with the dangerous H5N1 bird flu virus strain from a vaccine " ...
"it sent infected vaccines"

The few underlined words from above seems to point that the infection which killed the ferrets maybe didn't came from the live virus part of this bf vaccines, but from an additionaly infection by an bf virus impurity present into the vaccines.

Maybe it is early to said if the news words are not enaugh precise, or if such additional virus infect was realy present.

If the viral impurity was present, how the production facility output control machinery didn't locate the impurity danger?

Maybe the legislators in Austria must change, reinforce and more strenghten the needed technical machinery, the international production/export/import control line guideliness, and the penalty for all vaccine production sites ...

 

[Gert van der Hoek]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

MACHINETRANSLATED

Recently the threat of avian flu from the vaccine are defective in order

Any person who in connection with the testing of new influenza vaccines, a risk that they could infect the bird flu virus, are in order. That on Tuesday confirmed the main hygienist of Michael Vit.

17. 2. 2009 13:52

"Today it expired twice incubation period for possible infection of avian influenza virus, and nothing happened. People are in order. Jim or anyone else any danger, "said Vit.

Responded to the information that the aggressive avian influenza virus H5N1 vaccine inadvertently included the Austrian pharmaceutical companies Baxeter, which tested the bioassay in Konarovice on cologne.

"Tests are carried out with the H3N2 type of influenza vaccine from 30 January. Experimental ferrets began to have health problems 6th February and some have died. The same day we learned about it and take the necessary measures, "said Vit.

Employees got the antidote

He informed that all who come in contact with experimental animals, or are otherwise involved in the experiment, immediately received antiviral Tamiflu. All were also examined by modern molecular methods to eliminate the possibility that the infected aggressive bird flu virus H5N1.

"Nobody has been infected," said V?t that hygienic cooperate with veterinary services. The under Vitus revealed that the animals were infected deadly bird flu virus H5N1. All ferrets were destroyed and the farm has undergone and is undergoing extensive disinfection of all premises, "he added Vit.

According to the State Veterinary Administration spokesman Josef April but "is not no fun." The company Baxter acknowledged that the error was already in Austria and across the border to the Czech Republic has already traveled infested consignment. This happened probably in the packaging.

http://www.novinky.cz/clanek/161615-lide-ohrozeni-ptaci-chripkou-z-vadne-vakciny-jsou-v-poradku.html

 

[tropical]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

MACHINETRANSLATED
...

17. 2. 2009 13:52

"Tests are carried out with the H3N2 type of influenza vaccine from 30 January. Experimental ferrets began to have health problems 6th February and some have died. The same day we learned about it and take the necessary measures, "said Vit.

Employees got the antidote ... antiviral Tamiflu.
...
The under Vitus revealed that the animals were infected deadly bird flu virus H5N1. All ferrets were destroyed and the farm has undergone and is undergoing extensive disinfection of all premises, "he added Vit.

... the error was already in Austria and across the border to the Czech Republic has already traveled infested consignment. This happened probably in the packaging.

http://www.novinky.cz/clanek/161615-lide-ohrozeni-ptaci-chripkou-z-vadne-vakciny-jsou-v-poradku.html

Thank you very much Dutchy for the more wide explained news text.

So from the above text news sentences, the vaccines are for H3N2,
the impurity infection agent the H5N1,
and the H5N1 was inserted in the packaging in Austria.

Now, if for packaging it can be assumed that it means (the only possible place of mixing into the virus other than by infecting the ampules/injector) inserting the vaccine liquid mist H5N1 viral impurities into the ampules or syringes, it must be prior passed the output quality control sector.

How is it possible that one high virulent pandemic virus was at hand there at the insertion liquids point, when the handled vaccine stocks were only the H3N2 ones?

If the above would be appured to be true, it can't be an natural event.

If at the inserting liquids point didn't be any impurity viral agent mixing,
than it reminds me the gsgs recent post at one FT thread, about that it was noted by news texts that a research was conducted on bird flu at an lab mixing the H3N2 virus with an H5N1 virus.

That way, we got an H3N2 virus carrying H5N1 on.

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 ...

 

[sharon sanders]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

hat tip Fla Medic -

Looks like H5N1 was involved......ooof!

Prague -

An Austrian pharmaceutical firm sent a flu vaccine, which it had accidentally contaminated with the deadly H5N1 bird flu virus, for testing in the Czech Republic, a report said Tuesday. The Austrian firm Baxter said it contaminated the vaccine with the dangerous virus by accident, likely during packaging in Austria, the Mlada Fronta Dnes daily reported, citing Baxter's representative.

Baxter shipped the infected vaccine to the Czech biomedical firm Biotest for testing on ferrets in late January.

None of Biotest's 13 employees, who had been exposed to the highly pathogenic virus for a week, contracted the disease.

According to the World Health Organization figures, the bird flu has killed 254 people, mostly in Asia and Africa, including four deaths reported in Turkey.

The Czech Republic's chief epidemiologist Michael Vit said that it was unclear whether the Biotest workers had been under a high risk of infection as the Czech authorities did not know how much virus the vaccine contained.

Officials, however, hinted that the situation could have been serious. "Thank God it did not spread," Vit said.

The Czech company managed to prevent the virus from spreading outside the lab to poultry breeds, which would have had to be culled in such an event.

"If it were to spread to poultry farms it would have caused serious problems," said Josef Duben, a spokesman for the Czech State Veterinary Administration.

The exposed employees were given Tamiflu medicine and have been regularly tested, Vit said.

The infected ferrets had to be culled and the laboratory, which is located 70 kilometres east of the Czech capital Prague, was disinfected.

http://www.earthtimes.org/articles/...ly-vaccine-for-testing-in-czech-republic.html

 

[sharon sanders]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Thread on Poland homeless vaccine subjects:

http://www.flutrackers.com/forum/showthread.php?t=73106

 

[Commonground]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

People in the Kol?n threatening disease bird flu


Author: CTK
17.02. 07:36

Some people in the Czech Republic against the deadly bird flu disease. Mlad? fronta Dnes writes that the aggressive bird flu virus H5N1 vaccine inadvertently included the Austrian pharmaceutical firm Baxter, the company tested in the bioassay Konarovice in the Kol?n.

Find themselves in danger all those who came into contact with ferrets, in which the vaccine was tested. No one was eventually infected. According to experts, it was lucky that the virus has not between populations.

"Vaccine tested in the bioassay to fretk?ch from the beginning of January. Research has allowed the Ministry of Industry and Trade. Suddenly started ferrets pine and research was completed on February 6," said the main hygienist of Michael Vit. Subsequently, the State Veterinary Administration revealed that the animals were infected with a virus deadly bird flu. "All the ferrets we had to destroy a business close," said spokesman Joseph Veterinarians April.

Find themselves in danger all those who came with infected ferrets in contact. "Thirteen people immediately receive a medicine Tamiflu, and all tests passed. Fortunately, it appeared that no one is infected. Even though they have incubation period in a row, but is still possible to test for the presence of antibodies in the blood," said Vit. April added that "it's a serious warning, no it was not fun."

The company Baxter acknowledged that the error was already in Austria and sent across the border already "infected shipment. "It happened probably in the package. We have testing company," said Richard Tischler of company Baxter. According to him, given the drug Tamiflu even 29 people.
Read full post and comments

 

[Commonground]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press


People threatening disease deadly bird flu

Feb 17 2009 4:21, 9:43 updated
Lethal avian flu finds itself in the Czech Republic and thanks only to chance it nenakazili people. The bioassay in Konarovice vaccine tested in the Kol?n Austrian pharmaceutical company Baxter, which it develops. However, the vaccine contained the aggressive bird flu virus H5N1.


State Veterinary Administration revealed that the animals were infected with a virus deadly bird flu.

Austrians to find a few weeks after the beginning of the tests. But it was too late.
"Vaccine tested in the bioassay to fretk?ch from the beginning of January. Research has allowed the Ministry of Industry and Trade. Suddenly started ferrets pine and research was completed on February 6," says the main hygienist Michael Vit. In the immediate vicinity of the virus, researchers are moving from 30 January.
Subsequently, the State Veterinary Administration revealed that the animals were infected with a virus deadly bird flu. "All the ferrets we had to destroy a business close," says spokesman Joseph Veterinarians April. The disinfectant measures deployed sedmdes?tiprocentn? ethanol, which, according to April "completely kills all living."

The drug was given immediately thirteen people
The danger is suddenly found themselves all who came with infected ferrets in contact. "Thirteen people immediately receive a medicine Tamiflu, and all tests passed. Fortunately, it appeared that no one is infected. Even though they have incubation period in a row, but is still possible to test for the presence of antibodies in the blood," says Vit.
If a researcher was infected, before the examination could infect many people. That the virus has not only to other residents because of luck, allowed themselves experts.
A similar case in the Czech Republic or veterinarians not always hygienic. "It is a serious warning, no it was not fun," says April. The company Baxter admits that it has become a problem in Austria and sent across the border already "infected shipment.
"It happened probably in the package. We have testing company," says Richard Tischler of company Baxter. According to him, even given the drug Tamiflu twenty-nine people.

The control system is not very depth
During the development of drugs for the animal tests needed to permit the Ministry of Industry and Trade, but the medicines and their risks otherwise knows nothing. And approval of the Ethics Committee Ministry of Agriculture, the animals will be treated well.
The problem is that in similar tests in the Czech Republic, the laws protect more animals than people. "Please take care of ethical aspects of animal tests, but that there are serious risks to people, no one not dealt with," says Director of State Institute for Drug Control Martin Benes.

Authors:
Bohdan Jaro?ov? MF DNES

Lenka Petr??ov? MF DNES

 

[Commonground]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press


Recently the threat of avian flu from the vaccine are defective in order


The main hygienist of Michael Vit.
Photo: Lukas Taborsky, Right

Any person who in connection with the testing of new influenza vaccines, a risk that they could infect the bird flu virus, are in order. That on Tuesday confirmed the main hygienist of Michael Vit.


17. 2. 2009 13:52
"Today it expired twice incubation period for possible infection of avian influenza virus, and nothing happened. People are in order. Jim or anyone else any danger, "said Vit.

Responded to the information that the aggressive avian influenza virus H5N1 vaccine inadvertently included the Austrian pharmaceutical companies Baxeter, which tested the bioassay in Konarovice on cologne.

"Tests are carried out with the H3N2 type of influenza vaccine from 30 January. Experimental ferrets began to have health problems 6th February and some have died. The same day we learned about it and take the necessary measures, "said Vit.

Employees got the antidote
He informed that all who come in contact with experimental animals, or are otherwise involved in the experiment, immediately received antiviral Tamiflu. All were also examined by modern molecular methods to eliminate the possibility that the infected aggressive bird flu virus H5N1.

"Nobody has been infected," said V?t that hygienic cooperate with veterinary services. The under Vitus revealed that the animals were infected deadly bird flu virus H5N1. All ferrets were destroyed and the farm has undergone and is undergoing extensive disinfection of all premises, "he added Vit.

According to the State Veterinary Administration spokesman Josef April but "is not no fun." The company Baxter acknowledged that the error was already in Austria and across the border to the Czech Republic has already traveled infested consignment. This happened probably in the packaging.

V?clav Pergl, Right

 

[Sally Furniss]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

PRAGUE, Feb. 17 (Xinhua) -- Thirteen Czech researchers have been exposed to the H5N1 bird flu virus strain through a contaminated vaccine obtained from an Austrian company, a newspaper reported Tuesday.

The 13 people who had contact with the ferrets were in danger but were not infected with the lethal virus, said Josef Duben, a spokesman for the Czech veterinary authority.

Duben told the Mlada fronta Dnes (MfD) that the researchers were given an anti-viral vaccine and underwent tests.

"Fortunately, none of them got infected," Duben said.

The bird flu virus was being tested positive on ferrets by the Biotest company in Konarovice when the animals began to die.

"Suddenly the ferrets started dying, so the research stopped on Feb. 6," said Michael Vit, the Czech chief sanitary official.

Officials said the ferrets had become infected with the lethal bird flu virus and to be euthanized.

Baxter, the Austrian pharmaceutical company that developed the vaccine, admitted that it mistakenly sent infected material to the Czech Republic.

http://news.xinhuanet.com/english/2009-02/18/content_10838633.htm

 

[JJackson]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

The information in the news accounts pasted above is basically correct, according to Baxter.
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 Avir Green Hills, 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. Both sites have been cleaned up since the problem came to light and there have been no human infections.

While this pathogen may well be in some of the wild birds flying around the European countryside having it reproducing in a mammalian host is a much bigger problem. One assumes - and hopes - there will be some kind of formal investigation at some stage as a pathogen which should only be handled in BSL3 facilities has been allowed out of the lab and sent across international boarders.

 

[sharon sanders]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Thanks for the update JJackson.

 

[SuperNova1987A]

Re: Several Czechs threatened with bird flu - press

Re: Several Czechs threatened with bird flu - press

Ferrets infected with H5N1 were for the test of H3N2 vaccines.
So, they were to be infected with H3N2 virus later.
Isn't it a perfect situation for antigenic shift?
Sorry for the ferrets, but thank god they started dying.
Otherwise, a pandemic virus may be created.

If this is the case, the Austrian company should be closed
until the cause of this accident is confirmed and all the
preventive measures are implemented and so confirmed by
appropriate international organisations.

___________________
SN1987A

 

[JJackson]

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.