Baxter bird flu botch
Category: Big Pharma • Bird flu • Vaccines
Posted on: February 28, 2009 7:04 AM, by revere
In a post the other day on some kind of flu vaccine mishap in Austria we called it a colossal screw-up. It turns out we may have understated the case. Maybe. Because while more details are leaking out, the company responsible for it, Baxter International, isn't saying exactly what happened on the grounds that it is confidential business information. You almost have to admire that kind of arrogance. Almost. Meanwhile Helen Branswell brings us more details:
The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses.And an official of the World Health Organization’s European operation said the body is closely monitoring the investigation into the events that took place at Baxter International’s research facility in Orth-Donau, Austria.
[snip]
The contaminated product, a mix of H3N2 seasonal flu viruses and unlabelled H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany. (Helen Branswell, Canadian Press, via The Sun)
One of the big fears is that people or animals co-infected with a seasonal flu virus of humans and a virulent avian flu virus like H5N1 will act as a mixing vessel. Flu viruses each have eight genetic packages within them and when co-infecting a cell they can mix and match (reassortment), thus producing new hybrid bird-human viruses. Baxter put both viruses in the same vial, presumably for use as a vaccine. Baxter is calling the mixture an "experimental virus material," whatever that is. All we know is that a nasty live virus cocktail of human and bird influenza virus was made (Baxter says accidentally). Exactly to whom it was given, if anyone, is not being publicly divulged. We have a news report from an Austrian paper dated February 11, a Wednesday, that tells of 19 people being seen as outpatients at a Vienna hospital the previous Monday (February 9) because of exposure to "bird flu virus." The article said no one was sick, there was no evidence of infection, and the females were prophylaxed with antivirals (presumably Tamiflu).
WHO's European regional office in Copenhagen is saying they are confident there is no public or occupational health risk "at present," but they also acknowledge they don't know exactly what happened. They also say they do not any evidence that any reassortment occurred. I'm not sure exactly what evidence they looked at or have available, so I don't know how to interpret this absence of evidence. I'm certainly not reassured that unlabeled live H5N1 virus was released, even if just to another lab. There are people and animals in laboratories that were exposed and could have resulted in the virus getting into the general community in a major city with many international links.
Baxter's not saying much. Branswell quotes a company spokesperson as saying the incident happened through a combination of “just the process itself, (and) technical and human error in this procedure.” This doesn't sound very reassuring, either, because it sounds like there is a process that is error prone ("technical" and human). If Baxter's name sounds familiar it may be because almost exactly a year ago they were in the news over a series of fatal allergic reactions among dialysis patients who used the blood thinner heparin they manufactured. It turned out their heparin came from China and contained an adulterant, oversulfated chondroitin sulfate. Patients in six countries and over a dozen states in the US had serious adverse reactions and more than 80 deaths. At the time, Baxter said on their website that they "will not sell another vial of heparin until the company has helped to create a system in which the quality and safety of heparin is secured." (Medpage Today)
They weren't saying anything about the safety of their bird flu products, then. And not much now, either.
Viral Pandemic H5N1 flu threat: Baxter contaminates European labs by error
It could be a Hollywood Worst Case Thriller, but it is real: According to the scientific network PROMED, Baxter International Inc. in Austria "unintentionally contaminated samples with the bird flu virus that were used in laboratories in 3 neighboring countries, raising concern about the potential spread of the deadly disease". As PROMED reports, the contamination has been 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", the network-alert-system is quoting. "This was infected with a bird flu virus," Rosenberger said. "There were some people from the company who handled it." There are severe signs that the long expected pandemic avian influenza could be on its way to conquer the world - even without Baxter's error driven help. by Vlad Dan Georgescu and Marita Vollborn
First deaths in Asia concern little children, which from virological point of view is a rather new aspect, and could be the evidence for a new spread. While scientists expect this pandemic to happen in the near future, the new President should also stay alert: A coming influenza pandemic would deteriorate the global economy even without financial crisis, recession - or Baxter.
Evidence for the global threat comes from China, where a 2 year old girl has been confirmed to be infected with bird flu in the northern Shanxi Province, as government officials said last Saturday. The child was found ill on 7th of January in the central Hunan province - the little patient still is in critical condition. According to the test result of the Chinese Center for Disease Control and Prevention, the girl had been tested positive for the H5N1 strain of avian influenza.
On the other site of the globe, the Ministry of Health and Population of Egypt announced a new human case of avian influenza A(H5N1) virus infection last week, the case being a 21 month old girl Kerdasa District.
“Infection with the H5N1 avian influenza virus was diagnosed by PCR at the Egyptian Central Public Health Laboratory and subsequently confirmed by the U. S. Naval Medical Research Unit No. 3 (NAMRU-3) laboratories”, reports the special wire PROMED. According to PROMED, investigations into the source of her infection indicate a recent history of contact with sick and dead poultry - 23 similar cases in Egypt have been fatal up to date.
Old Europe as leading research power?
Given such facts, Mr. Obama should follow European research policy: European research on vaccine development for pandemic influenza has been financed since 2001 by the European Union. Early projects worked to develop an egg-free vaccine, which is faster and safer to produce, along with innovative application techniques. Research is now underway with the objectives of fighting the disease at the source (infected birds) and protecting human populations through pandemic influenza vaccines. Future EU research will improve vaccine efficiency by adding adjuvants, substances that boost the body’s immune response to vaccine antigen. Additionally, research teams are currently focused on developing a universal flu vaccine that could provide a lifetime of protection from influenza.
Latest surveillance data coming through the European Centre for Disease Prevention and Control (ECDC) from virologists and clinicians indicates that the influenza A(H3N2) virus is the predominant strain in Europe so far this season (2008/2009). Based on the data published by ECDC the pharmaceutical company Roche confirms that the oral antiviral Tamiflu (oseltamivir) is fully active against influenza A(H3N2) and influenza B, which currently comprise 94 percent of circulating viruses in Europe this year. Tamiflu resistance reported in the 2008-2009 influenza seasons is confined to H1N1. No resistance has been seen with other circulating seasonal viruses - H3N2 and influenza B.
"Recent media reporting has elevated awareness of the H1N1 seasonal resistance seen this year in the United States and the Far East. However, in Europe the picture is different with H3N2 being the dominant strain so far. The circulating H3N2 viruses, which often cause a more severe illness than H1N1, are sensitive to oseltamivir, which means that oseltamivir will be active against the vast majority of influenza infections in Europe this season, if current trends continue," comments Prof Albert Osterhaus, Head of Virology, Erasmus Medical Centre, Rotterdam. "It is important that doctors understand that oseltamivir remains an effective treatment for patients across Europe."
Flu alert for the new President
However, the situation in the United States is more alerting, according to the Centers for Disease Control and Prevention(CDC). A new University of Colorado at Boulder study showed the resistance of the avian flu virus to a major class of antiviral drugs "is increasing through positive evolutionary selection, with researchers documenting the trend in more than 30 percent of the samples tested", as the scientists report. Even if the expected influenza pandemic did not start yet, there is no doubt about the comeback of the lethal virus: The first Pandemic Influenza occurred in three waves in the United States - exactly 90 years ago, between 1918 and 1919.
Last December, the Austrian branch of US vaccine company Baxter sent a batch of ordinary human H3N2 flu, altered so it couldn't replicate, to Avir Green Hills Biotechnology, also in Austria. In February, a lab in the Czech Republic working for Avir alerted Baxter that, unexpectedly, ferrets inoculated with the sample had died. It turned out the sample contained live H5N1, which Baxter uses to make vaccine. The two seem to have been mixed in error.
Markus Reinhard of Baxter says no one was infected because the H3N2 was handled at a high level of containment. But Ab Osterhaus of Erasmus University in the Netherlands says: "We need to go to great lengths to make sure this kind of thing doesn't happen."
Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences. While H5N1 doesn't easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people.
(original article)
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