- The name of the Avir Green Hills subcontractor in the
Czech Republic is Biotest. They are located in the town of Konarovice ,
Czech republic. These are the guys who tested the "experimental vaccine
material" on their ferrets which produced 100% mortality. So the trail
- Baxter (Orth-Donau, Austria) --> Avir Green Hills
Biotechnology (Austria) --> 16 labs in Three Countries (Czech Republic,
- One of these 16 labs was Biotest (Konarovice, Czech Republic)
which tested the "experimental vaccine material" on their ferrets
and found 100% lethality.
- ======== Professional Czech Translations ========
- February 18, 2009
- It is a business secret - company refuses to comment
on mistake in safeguarding deadly vaccination
- European Medicines Agency (EMEA) is investigating Austrian
branch of American pharmaceutical company Baxter. It is after pharmacists
from Austrian Ortha sent vaccination preventing flu to the Czech Rep for
testing and this vaccination found to be infected with a deadly virus of
the bird flue (H5N1).
- Czech newspaper MF DNES brought attention to this case
and consequently, related laws might get changed.
- Michael Vit, a chief hygienist and advisor from Ministry
of Health, says: "Our goal is to obtain a prior documentation for
each and every vaccination or drug coming for testing here, proving to
us that these materials are not contaminated. Or, we need to be able to
pre-test them in our national laboratory. So far, it is not the case."
- Czech research company Biotest (in Konarovice town),
testing this critical vaccination on lab ferrets, was forced to end the
testing process after a week and to kill the infected animals. Researchers
(13) working with this vaccine got immediately a shot of anti-virus Tamiflu
and are under the supervision of hygienists. Luckily, the researchers are
not infected, says Michael Vit.
- The testing was permitted by Czech Ministry of Industry
and Trade, yet this Ministry does not have any real control over it. In
the future, these circumstances should change. Newly, Ministry of Health
and National Drug Control Committee should supervise all the medical testing
and research. Austrian workers will have to explain to these Czech agencies
how could such a serious mistake possibly happen and who is responsible
- Spokesman of American Baxter, Richard Tischler, revealed
to MF Dnes newspaper only limited amount of information. He said that the
mistake happened in the Austrian branch and that it was a procedural mistake.
Other than that, it is our business secret and I can't talk about it. However,
I can assure you that we made steps to prevent similar mistake from happening
again in the future.
- According to Tischler, this mistake happened only in
a batch shipped to Czech Biotest. Baxter is one of the six international
companies entitled to develop vaccination preventing flu. In Baxter labs,
a deadly virus of the bird flu is stored as well as vaccination, made by
the company, which should prevent the flu.
- Biotest was supposed to test anti-flu vaccination that
should serve Europeans during the next flu season. The researchers admit
that a situation like this never happened in the Czech Rep yet. It is an
extraordinary situation which showed a gap in our legislature and we were
not ready for it, says Roman Prymula, chairman of Czech vaccination society.
We can't pretend that nothing happen; it is a major mistake. Some 60 years
ago in the US, children have paid for the similar mistake by getting polio.
And later on, in Germany, researchers had mishandled TBC vaccination, said
Jiri Beran from Center for vaccination and travel medicine.
- Austrian Bird Flu Came To The Czech Republic And Germany
- March 4, 2009
- Deadly virus of the bird flu suddenly appeared on several
places in Europe. According to MF Dnes newspaper, people from Austrian
branch of Baxter were testing "contaminated vaccine material"
not only in a Czech lab, but also in labs of two neighboring countries.
- Vaccine material contaminated with the bird flu was tested
not only in Austria, but also in the Czech Rep, Germany and Slovenia. Everywhere,
the same problem was observed, said Michael Vit.
- Not one laboratory had a clue about this. Last day in
January, Austrian pharmacists sent "by an accident" a virus for
testing to four different labs and this virus, for its dangerous character,
is actually listed as a possible biological weapon.
- The Czech lab is actually under an investigation by National
institute for nuclear safety now. Neither the Czech, nor Austrian labs
informed the Institute about the incident. Baxter comp. itself had learned
about this contamination incident about six days later when infected ferrets
started to behave strangely.
- We should be definitely informed; it is against the law,
said Dana Drabova, a chairperson of National institute for nuclear safety,
especially, if the virus of bird flue H5N1 belongs on a list of dangerous
materials. Biotest might face a penalty as high as five millions of CZK
if we prove that this mistake is on a Biotest's side.
- European medicine agency (EMEA) is tracking this incident
- Baxter refused accusations that company would be conducting
testing on people: "We were intended to send a clear virus of common
flu for testing to Czech Biotest; by an accident, we sent the virus of
bird flue. The testing material got mixed up, said Tischler. According
to him, the risk of the bird flu getting out of the labs was very low.
Specific process that was used during the production of this testing material
will be never used again.
- Contaminated Vaccination Was Tested Not Only In The Czech
- PRAGUE -- Vaccine material contaminated with the bird
flu was tested not only in Austria, but also in the Czech Rep, Germany
and Slovenia. Everywhere, the same problem was observed, said Michael Vit.
None of the labs had a clue about it.
- Tischler, rep from Baxter, emphasized for Czech Press
Agency, that the material was produced solely for a research and never
meant to be used for any other purposes or used on human beings. According
to Tichler, this testing material was not sent by American Baxter, but
by Austrian AVIR Greenhills which also hired Czech Biotest.
- Contamination itself happened during this one specific
research project for AVIR Greenhills in labs of Baxter company. And this
certain process will not be performed ever again, said Tischler. Austrian
institutions dealing with public health and safety approved Baxter's safety
and prevention steps taken afterward, describing them as adequate to this
kind of situation.
- According to Tischler, designated people did work with
this experimental material in isolated labs. Also, reps from Biotest said
that "this project was conducted under standard conditions - with
a high level of work safety, in isolated labs and with use of appropriate
protection tools. No researcher was infected".
- In the Austrian branch, representatives from EMEA started