All Ferrets Given Baxter Alleged Swine Flu Shot Died

Archive Number 20090226.0801
Published Date 26-FEV-2009
Subject PRO/AH> Avian influenza, accidental distribution - Czech Rep. ex Austria (02)

AVIAN INFLUENZA, ACCIDENTAL DISTRIBUTION - CZECH REPUBLIC ex AUSTRIA (02)
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A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


[1]
Date: Wed 25 Feb 2009
Source: CHealth, Canadian Press report [edited]



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 4 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 license 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 2 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 2 ways pandemic viruses are created.
Research published last summer [2008] 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, Illinois, 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 [2008]. 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 2009 when researchers at the Czech sub- contractor
inoculated ferrets with the material and the animals promptly died.
Baxter learned about the problem on 6 Feb 2009, 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 are 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 in which 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.

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[The article above provides some of the information requested in the
preceding ProMED-mail posting "Avian influenza, accidental
distribution - Czech Rep. ex Austria: RFI," archived as no.
20090225.0776, namely that the countries receiving the contaminated
material were the Czech Republic, Slovenia and Germany. The
contaminated virus was a strain of H3N2 seasonal influenza virus. -
Mod.CP]

******
[2]
Date: Thu 26 Feb 2009
From: Christopher Bona


A statement on behalf of Baxter
-------------------------------
I would like to provide the following update to a posting on ProMED
dated 25 Feb 2009 (Avian influenza, accidental distribution - Czech
Rep. ex Austria: RFI).

The H5N1 strain was the A/Vietnam/1203/2004 strain, received from a
WHO reference centre. All information concerning this incident has
been provided to the involved national authorities and appropriate
international bodies such as ECDC and WHO.

--
Christopher Bona
Director, Global BioScience Communications
Corporate Communications
Baxter International Inc.
One Baxter Parkway
Deerfield, IL 60015


[ProMED-mail thanks Christopher Bona for providing this precise
description of the strain of avian A/H5N1 influenza virus involved in
the incident. - Mod.CP]

[see also:
Avian influenza, accidental distribution - Czech Rep. ex Austria: RFI
20090225.0776]