sábado, 21 de marzo de 2020

"Incidente" Baxter 2009 y la vacuna contaminada de la gripe aviar (Influenza H5N1)

Una noticia informaba en febrero de 2009 que la farmaceutica BAXTER envió material experimental contaminado por el virus de la gripe aviar H5N1.


TORONTO - 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.
"At this juncture we are confident in saying that public health and occupational risk is minimal at present," medical officer Roberta Andraghetti said from Copenhagen, Denmark.

"But what remains unanswered are the circumstances surrounding the incident in the Baxter facility in Orth-Donau."
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.
The contamination incident, which is being investigated by the four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the product and they died. Ferrets shouldn't die from exposure to human H3N2 flu viruses.
Public health authorities concerned about what has been described as a "serious error" on Baxter's part have assumed the death of the ferrets meant the H5N1 virus in the product was live. But the company, Baxter International Inc., has been parsimonious about the amount of information it has released about the event.
On Friday, the company's director of global bioscience communications confirmed what scientists have suspected.
"It was live," Christopher Bona said in an email.
The contaminated product, which Baxter calls "experimental virus material," was made at the Orth-Donau research facility. Baxter makes its flu vaccine -- including a human H5N1 vaccine for which a licence is expected shortly -- at a facility in the Czech Republic.
People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.
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.
That mixing process, called reassortment, is one of two ways pandemic viruses are created.
There is no suggestion that happened because of this accident, however.
"We have no evidence of any reassortment, that any reassortment may have occurred," said Andraghetti.
"And we have no evidence of any increased transmissibility of the viruses that were involved in the experiment with the ferrets in the Czech Republic."
Baxter hasn't shed much light -- at least not publicly -- on how the accident happened. Earlier this week Bona called the mistake the result of a combination of "just the process itself, (and) technical and human error in this procedure."
He said he couldn't reveal more information because it would give away proprietary information about Baxter's production process.
Andraghetti said Friday the four investigating governments are co-operating closely with the WHO and the European Centre for Disease Control in Stockholm, Sweden.
"We are in very close contact with Austrian authorities to understand what the circumstances of the incident in their laboratory were," she said.
"And the reason for us wishing to know what has happened is to prevent similar events in the future and to share lessons that can be learned from this event with others to prevent similar events. ... This is very important."
 

 
The details of a potentially dangerous virus contamination that affected research labs in four European countries may remain shrouded in mystery. While acknowledging responsibility for the mix-up, health care company Baxter says it will not reveal the exact chain of events that led the unsuspecting labs to receive H5N1, the highly lethal avian influenza virus, in samples of less dangerous flu strains.
In early February, a Baxter facility in Austria sent an Austrian research company, Avir Green Hills Biotechnology, samples of the human flu strain H3N2 that were contaminated with H5N1. Avir Green Hills sent the material on to subcontractors in the Czech Republic, Germany, and Slovenia. It wasn't until ferrets exposed to the samples started dying in the Czech lab that the mistake was discovered; H3N2 wouldn’t normally kill the animals. Although a few press stories emerged in late February, the affair has received little media attention in Europe.
Scientists and workers at all four labs have been tested, and none have become infected with H5N1, says Christopher Bona, director of global bioscience communications at Baxter's headquarters in Deerfield, Illinois. Baxter has helped sanitize the labs, and the virus samples have been destroyed, he adds. The company has cooperated with an audit by the Austrian government and has taken measures to prevent the incident from happening again, Bona says—but he declines to explain what happened at the Baxter facility in Orth/Donau, where the contamination occurred. "It was a unique combination of process, technical, and human errors," Bona says, adding that further details would reveal proprietary information about Baxter's procedures. The Orth/Donau facility is a research lab, he notes, and is not involved in the production of Baxter's candidate H5N1 vaccine, which is made in the Czech Republic and is awaiting approval by European regulators.

https://www.sciencemag.org/news/2009/03/company-mum-details-flu-virus-mishap
MF DNES, 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).
 
 https://www.idnes.cz/zpravy/domaci/je-to-obchodni-tajemstvi-odmita-firma-komentovat-unik-smrtelne-vakciny.A090217_224441_domaci_anv 
 
 
 
La vacuna de BAXTER contra la gripe aviar (Influenza H5N1) fue aprobada finalmente para su uso en la Unión Europea por la EMA:
 
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. 
 
https://www.ema.europa.eu/en/medicines/human/EPAR/pandemic-influenza-vaccine-h5n1-baxter-ag

La periodista Jane Burgemeister presentó en abril cargos contra Baxter AG y Avir Green Hills por la producción de una vacuna contra la gripe aviar contaminada, junto a una denuncia por el acto deliberado de provocar y sacar provecho de una pandemia mundial, con cargos de bioterrorismo e intento de genocidio.


Summary of claims and allegations filed with FBI in Austria on June 10, 2009
In her charges, Burgermeister presents evidence of acts of bioterrorism that is in violation of U.S. law by a group operating within the U.S. under the direction of international bankers who control the Federal Reserve, as well as WHO, UN and NATO. This bioterrorism is for the purpose of carrying out a mass genocide against the U.S. population by use of a genetically engineered flu pandemic virus with the intent of causing death. This group has annexed high government offices in the U.S.
Specifically, evidence is presented that the defendants, Barack Obama, President of the U.S, David Nabarro, UN System Coordinator for Influenza, Margaret Chan, Director-General of WHO, Kathleen Sibelius, Secretary of Department of Health and Human Services, Janet Napolitano, Secretary of Department of Homeland Security, David de Rotschild, banker, David Rockefeller, banker, George Soros, banker, Werner Faymann, Chancellor of Austria, and Alois Stoger, Austrian Health Minister, among others, are part of this international corporate criminal syndicate which has developed, produced, stockpiled and employed biological weapons to eliminate the population of the U.S. and other countries for financial and political gain.

https://www.globalresearch.ca/journalist-files-charges-against-who-and-un-for-bioterrorism-and-intent-to-commit-mass-murder/14276 

Parlamento Austria 20/03/2009

Verschweigen eines schweren Laborzwischenfalls durch mit H5N1 verseuchten Grippeimpfstoff (1437/J)
(Divulgación de un incidente de laboratorio grave debido a la vacuna contra la gripe contaminada con H5N1 (1437 / J))
 
Pregunta del Dr. Dagmar Belakowitsch-Jenewein al Ministro Federal de Salud sobre el silencio de un grave incidente de laboratorio (en la República Checa) causado por la vacuna H5N1 (patógeno contra la gripe aviar)


https://www.parlament.gv.at/PAKT/VHG/XXIV/J/J_01437/index.shtml


Respuesta de dipl. Alois Stöger, del ministerio de Sanidad (Regierungsmitglied Bundesministerium für Gesundheit).
 
20/05/2009 
 
GZ: BMG-11001/0067-I/5/2009

"En una empresa ubicada en la Baja Austria, cierto material de investigación fue producido exclusivamente para fines de investigación (¡y no para uso humano!). Debido a errores de producción, el material de investigación estaba contaminado con el virus de la gripe aviar (Influenza A / H5N1). El material de investigación se obtuvo como parte de un proyecto de desarrollo para una nueva vacuna. Este material fue luego transferido a una empresa en la República Checa como parte del proyecto de investigación. Basado en el resultado de un experimento con animales, se observó la contaminación del material de investigación con el virus de la gripe aviar (influenza A / H5N1).

Este incidente fue comunicado por la empresa que opera en la República Checa y posteriormente fue denunciado a las autoridades sanitarias austriacas. 


El 9 de febrero de 2009, a las 5 p.m., se informó al Ministerio Federal de Salud (BMG) de la contaminación de un material producido para fines de investigación con el virus de la gripe aviar (Influenza A / H5N1).

Por parte de la autoridad sanitaria responsable a nivel nacional, se llevaron a cabo las encuestas y exámenes necesarios y se tomaron medidas para prevenir de manera proactiva posibles daños a humanos y animales.


Las medidas preventivas tomadas de manera proactiva incluyeron el uso profiláctico de un inhibidor de la neuraminidasa por personas potencialmente contaminadas y su examen médico en un hospital de Viena. Rápidamente se descubrió que no había enfermedad. (...)



No hubo y no hay razón para informar al público sobre la contaminación de un material producido para la investigación con el virus de la influenza aviar (influenza A / H5N1)


 https://www.parlament.gv.at/PAKT/VHG/XXIV/AB/AB_01457/fnameorig_158854.html

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