Russian Flu Caused By "ESCAPED" Virus , Contaminated Vaccines (WITH H5N1!!!) Killed Mammals RECENTLY When Given Contaminated FLU Shots

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<!-- / icon and title --> <!-- message --> Baxter Sent Bird Flu Virus to European Labs by Error, "The company was ?supposed to get non-infected testing vaccine, which was by mistake of the supplier contaminated with the H5N1 virus?
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.

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<!-- message --> 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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