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Remember this major news story from February? No? Search the US corporate news archives of your choice in vain.
http://www.torontosun.com/news/canada/2009/02/27/8560781.html
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.”
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Now back to “reality”. Remember how the “swine” flu was first described? Mexico City, April 2009:
http://www.guardian.co.uk/world/2009/apr/25/swine-flu-mexico/print
President Felipe Calderón said his government learned only on Thursday night what kind of virus Mexico was facing after tests by specialist laboratories in Canada confirmed the outbreak as a type – labelled A/H1N1 – not previously seen in pigs or humans. Few cases have had any contact with live pigs.
The WHO said the virus appeared to be able to spread from human to human and contained human virus, avian virus and pig viruses from North America, Europe and Asia. It might be completely new or has only now been detected.
Five months later, we get this parenthetical from Dr. Gupta:
http://pagingdrgupta.blogs.cnn.com/2009/09/23/i-went-to-afghanistan-and-all-i-got-was-h1n1/
(The term swine flu is a misnomer, as this strain is made up of several different components, including swine, but also avian parts.)
He must have been feverish.
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Meanwhile, the dangerously incompetent Baxter International has been banned from producing and distributing flu vaccine, right? Wrong.
http://www.baxter.com/about_baxter/press_room/press_releases/2009/10_07_09-celvapan.html
DEERFIELD, Ill., October 07, 2009 — Baxter International Inc. (NYSE: BAX) today confirmed that the European Commission (EC) has granted marketing authorization for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union.
Baxter continues to deliver vaccine to national public health authorities that have agreements with the company. Initial quantities of vaccine have already been received by a number of countries, including the UK and Ireland, for use in their national vaccination programs.
Baxter is confirming the safety and immunogenicity of CELVAPAN H1N1 in clinical trials and will supplement the licensure post-approval with data from its ongoing clinical trial program . Preliminary safety data from CELVAPAN H1N1 clinical trials in adults age 18 and older indicate the vaccine is well tolerated. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines.
Immunogenicity data from the first vaccination in adults will be submitted to the European Medicines Agency within days. The current dosing schedule, as specified in the EMEA mock-up licensure for CELVAPAN using another virus strain, calls for two 7.5 µg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for CELVAPAN H1N1. This study will also determine whether a lower dose, 3.75µg, is sufficient to induce the necessary immune response.
About Baxter’s Pandemic Vaccine Development
Earlier this year, the EMEA granted mock-up licensure for CELVAPAN using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk CELVAPAN H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of CELVAPAN H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
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http://www.msnbc.msn.com/id/9589897/
President Bush, increasingly concerned about a possible avian flu pandemic, revealed Tuesday that any part of the country where the virus breaks out could likely be quarantined and that he is considering using the military to enforce it.
“The best way to deal with a pandemic is to isolate it and keep it isolated in the region in which it begins,” he said during a wide-ranging Rose Garden news conference.
The president was asked if his recent talk of giving the military the lead in responding to large natural disasters such as Hurricane Katrina and other catastrophes was in part the result of his concerns that state and local personnel aren’t up to the task of a flu outbreak.
“Yes,” he replied.
Pentagon in charge
After the bungled initial federal response to Katrina, Bush suggested putting the Pentagon in charge of search-and-rescue efforts in times of a major terrorist attack or similarly catastrophic natural disaster. He has argued that the armed forces have the ability to quickly mobilize the equipment, manpower and communications capabilities needed in times of crisis.
But such a shift could require a change in law, and some in Congress and the states worry it would increase the power of the federal government at the expense of local control.
Bush made clear that the potential for an outbreak of avian flu is much on his mind, and has had him talking with “as many (world) leaders as I could find,” consulting a book he read over the summer on the 1918 Spanish flu pandemic that killed 40 million and meeting with staff and experts.
“I have thought through the scenarios of what an avian flu outbreak could mean,” he said.
He acknowledged that a quarantine — an idea sure to alarm many in the public — is no small thing for the government to undertake and that enforcing it would be tricky.
“It’s one thing to shut down airplanes,” Bush said. “It’s another thing to prevent people from coming in to get exposed to the avian flu.”
He urged Congress to give him the ability to use the military, if needed.
“I think the president ought to have all … assets on the table to be able to deal with something this significant,” he said.
As a standby precaution, Bush in April signed an executive order that added pandemic influenza to the government’s list of communicable diseases for which a quarantine is authorized. It gives the government legal authority to detain or isolate a passenger arriving in the United States to prevent an infection from spreading.
At the time the order was signed, a spokeswoman for the federal Centers for Disease Control and Prevention said the Public Health Service would probably recommend home quarantines when possible, but said they would be voluntary. It’s unclear whether the federal takeover of state and local quarantine powers that Bush discussed Tuesday would be limited just to travel or involve broader home quarantines as well.
Bush also said he has been urging world leaders to improve reporting on outbreaks of the virus, and exploring how to speed the production of a spray, now in limited supply, that “can maybe help arrest the spread of the disease.”
“One of the issues is how do we encourage the manufacturing capacity of the country, and maybe the world, to be prepared to deal with the outbreak of a pandemic?” he said.
Yet it is the pill Tamiflu, which makes symptoms less severe and shortens the duration of the illness, that is in short supply — not its harder-to-use inhaled competitor Relenza.
Experts agree there will certainly be another flu pandemic — a new human flu strain that goes global. However, it is unknown when or how bad that global epidemic will be — or whether the H5N1 bird flu strain now circulating in Asian poultry will be its origin.
Just in case, experts are tracking the avian flu, which has swept through poultry populations in large swaths of Asia since 2003, jumped to humans and killed at least 65 people.
Most human cases have been linked to a contact with sick birds, but the World Health Organization has warned the virus could mutate into a form that spreads easily among humans — changing it from a bird virus to a human pandemic flu strain.
http://edition.cnn.com/2009/US/07/28/military.swine.flu/index.html
The U.S. military wants to establish regional teams of military personnel to assist civilian authorities in the event of a significant outbreak of the H1N1 virus this fall, according to Defense Department officials.
The proposal is awaiting final approval from Defense Secretary Robert Gates.
The officials would not be identified because the proposal from U.S. Northern Command’s Gen. Victor Renuart has not been approved by the secretary.
The plan calls for military task forces to work in conjunction with the Federal Emergency Management Agency. There is no final decision on how the military effort would be manned, but one source said it would likely include personnel from all branches of the military.
It has yet to be determined how many troops would be needed and whether they would come from the active duty or the National Guard and Reserve forces.
Civilian authorities would lead any relief efforts in the event of a major outbreak, the official said. The military, as they would for a natural disaster or other significant emergency situation, could provide support and fulfill any tasks that civilian authorities could not, such as air transport or testing of large numbers of viral samples from infected patients.
As a first step, Gates is being asked to sign a so-called “execution order” that would authorize the military to begin to conduct the detailed planning to execute the proposed plan.
Orders to deploy actual forces would be reviewed later, depending on how much of a health threat the flu poses this fall, the officials said.
Brian is all over it. Yet somehow Mr. Williams and his fellow Trusted Faces and Voices in the US corporate media missed that Toronto Sun report about Baxter’s “accident”. Nevermind. Had you needed to know you would have been told.
