http://seattlepi.nwsource.com/national/apscience_story.asp?category=1500&slug=Bird%20Flu
U.S. buys $100 million of bird flu vaccine
By LAURAN NEERGAARD
AP MEDICAL WRITER
WASHINGTON -- Mass production of a new vaccine that promises to protect against bird flu is poised to begin, as the government on Thursday agreed to stockpile $100 million worth of inoculations.
The new contract with French vaccine maker Sanofi-Pasteur marks a major scale-up in U.S. preparation for the possibility that the worrisome virus could spark an influenza pandemic.
While the vaccine is still experimental, preliminary results from the National Institutes of Health's first testing in people suggest the inoculations spur an immune response that would be strong enough to protect against known strains of the avian influenza, sparking the new investment.
But just how many doses the $100 million will buy isn't yet clear.
That's because there is contrasting research on just how much antigen much be in each dose to provide protection, explained Sanofi spokesman Len Lavenda. The range is huge - from 15 micrograms of antigen per dose to 90 - and the protective amount likely will wind up somewhere in between, he said.
Previously, the government has said it has stockpiled 2 million doses of bird flu vaccine.
Sanofi stored that vaccine in bulk, and the 2 million estimate assumed a single 15-microgram dose per person, Lavenda said. In contrast, the preliminary NIH research suggested it may take two 90-microgram shots to provide protection.
Simple math suggests that means the $100 million purchase could provide enough doses to protect anywhere from 1.7 million people - "we're quite sure it's going to be a lot more than that," Lavenda said - to a maximum of 20 million people.
A study now under way in France pairs the vaccine with an immune booster, called an adjuvant, that may help stretch doses. Sanofi expects results later in the year.
Regardless of the ultimate number, clearing the way for mass production now is a big step. Sanofi's factory in Swiftwater, Penn., can produce bird flu vaccine in September and October - months not occupied making vaccine for regular winter flu - and separate bulk lots into agreed-upon doses later.
The government's ultimate goal is to stockpile 20 million vaccine doses, a first wave of protection if the H5N1 bird flu strain eventually sparks a pandemic.
It's a quest gaining urgency. The virus has now killed or led to the slaughter of millions of birds, mostly in Asia but in parts of Europe, too. Although it has killed only about 60 people, mostly poultry workers, that's because so far it doesn't spread easily from person to person. If that changes - and flu viruses mutate regularly - it could trigger a deadly worldwide outbreak, because H5N1 is so different from the flu strains that circulate each winter that people have no residual immunity.
The nation also plans to stockpile 20 million doses of anti-flu medication, and the government announced Thursday it was purchasing enough of the drug Relenza, from maker GlaxoSmithKline, to treat 84,300 people.
Already in stock is enough of a competing drug, Tamiflu, to treat 4.3 million. Tamiflu is a pill, while Relenza must be inhaled, a drawback. The government still is planning additional Tamiflu purchases.
"These counter-measures provide us with tools that we have never had prior to previous influenza pandemics," said Health and Human Services Secretary Mike Leavitt.
http://www.freerepublic.com/focus/f-news/1485526/posts
http://seattlepi.nwsource.com/national/apscience_story.asp?category=1500&slug=Indonesia%20Bird%20Flu
THE ASSOCIATED PRESS
JAKARTA, Indonesia -- Indonesia on Friday confirmed its fourth human death from the bird flu virus, and warned that more cases in the sprawling country were inevitable.
Tests from a Hong Kong laboratory showed that a 37-year-old woman who died last week had contracted the H5N1 bird flu virus, said Nyoman Kandon, the health ministry's director general for illness control and environmental health.
He said Indonesia would continue to report cases because the virus was rife in poultry farms across the country. "It will be like in Vietnam and Thailand," he told The Associated Press.
The virus has swept through poultry populations in large swathes of Asia since 2003, resulting in the deaths of tens of millions of birds - and 63 people, most of them in Vietnam and Thailand.
Most of the human deaths have been linked to contact with sick birds. But the World Health Organization has warned that the virus could mutate into a form which is more easily transmitted from human to human, possibly triggering a pandemic that could kill millions worldwide.
Relenza (zanamivir)
FDA has approved Relenza (zanamivir), an anti-viral drug, for persons aged 7 years and older for the treatment of uncomplicated influenza virus. This product is approved to treat type A and B influenza, the two types most responsible for flu epidemics. Clinical studies showed that for the drug to be effective, patients needed to start treatment within two days of the onset of symptoms. The drug seemed to be less effective in patients whose symptoms weren't severe or didn't include a fever.
Relenza is a powder that is inhaled twice a day for five days from a breath-activated plastic device called a Diskhaler. Patients should get instruction from a health-care practitioner in the proper use of the Diskhaler, including a demonstration when possible. Relenza has not been shown to be effective, and may carry risk, in patients with severe asthma or a lung condition called chronic obstructive pulmonary disease. Some patients with mild or moderate asthma experienced bronchospasm (marked by shortness of breath) after using Relenza.
Some patients have had bronchospasm (wheezing) or serious breathing problems when they used Relenza. Many but not all of these patients had previous asthma or chronic obstructive pulmonary disease. Relenza has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, Relenza is not generally recommended for people with chronic respiratory disease. Anyone who develops bronchospasm worsening respiratory symptoms such as wheezing and shortness of breath should stop taking the drug and call their health-care provider. Patients with underlying respiratory disease should have a fast-acting inhaled bronchodilator available when taking Relenza.
Relenza is not approved for use in prevention of influenza (prophylaxis) and is not a substitute for influenza vaccine.
Transcript of the Antiviral Advisory Committee Date: 2/24/99; Topic: Relenza (zanamivir); NDA 21-036. Optional format: PDF. Also available: Minutes PDF.
Combined Memorandum. (Issued, 7/15/99, Posted, 8/27/99) This memo addresses several concerns raised by the Antiviral Drug Advisory Committee held on February 24, 1999.
Division Director Memorandum. (Issued, 7/26/99, Posted, 8/27/99) This memo states the Director's rationale for recommending approval of Relenza for treatment of uncomplicated influenza, plus comments on other noteworthy aspects of the application.
http://www.fda.gov/cder/news/relenza/default.htm
http://abcnews.go.com/Primetime/Investigation/story?id=1130392&page=1
Sept. 15, 2005 — It could kill a billion people worldwide, make ghost towns out of parts of major cities, and there is not enough medicine to fight it. It is called the avian flu.
This week, at the United Nations Summit in New York, both the head of the U.N. World Health Organization and President Bush warned of the virus's deadly potential.
Avian Flu: Is the Government Ready for an Epidemic?
Volunteers Needed for 'Primetime' Test
"We must also remain on the offensive against new threats to public health, such as the Avian influenza," Bush said in his speech to world leaders. "If left unchallenged, the virus could become the first pandemic of the 21st century."
According to Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University's Mailman School of Public Health, Bush's call to remain on the offensive has come too late.
"If we had a significant worldwide epidemic of this particular avian flu, the H5N1 virus, and it hit the United States and the world, because it would be everywhere at once, I think we would see outcomes that would be virtually impossible to imagine," he warns.
Already, officials in London are quietly looking for extra morgue space to house the victims of the H5N1 virus, a never-before-seen strain of flu. Scientists say this virus could pose a far greater threat than smallpox, AIDS or anthrax.
"Right now in human beings, it kills 55 percent of the people it infects," says Laurie Garrett, a senior fellow on global health policy at the Council on Foreign Relations. "That makes it the most lethal flu we know of that has ever been on planet Earth affecting human beings."
No Natural Immunity
The Council on Foreign Relations devoted its most recent issue of the prestigious journal, Foreign Affairs, to what it called the coming global epidemic, a pandemic.
"Each year different flus come, but your immune system says, 'Ah, I've seen that guy before. No problem. Crank out some antibodies, and I might not feel great for a couple of days, but I'll recover,'" Garrett says. "Now what's scaring us is that this constellation of H number 5 and N number 1, to our knowledge, has never in history been in our species. So absolutely nobody watching this has any natural immunity to this form of flu."
Like most flu viruses, this form started in wild birds — such as geese, ducks and swans — in Asia.
"They die of a pneumonia, just like people," says William Karesh, the lead veterinarian for the Wildlife Conservation Society. "When you open them up, you do a post-mortem exam. Their lungs are just full of fluid and full of blood."
Karesh has been tracking this flu strain for the last several years as it has gained strength, spreading from wild birds to chickens to humans.
"We start at a market somewhere in Guangdong Province in China," explains Karesh. "And it's packed with cages, and you'll have chickens, and you'll have ducks. You might have some other animals — cats, dogs, turtles, snakes — and they're all stacked in cages, and they're all spreading their germs to each other."
In response, Asian governments have killed millions of chickens in futile attempts to stop the flu's spread to humans.
"The tipping point, the place where it becomes something of an immediate concern, is where that virus changes, we call it mutates, to something that is able to go from human to human," says Redlener, director of the National Center for Disaster Preparedness.....
http://www.alertnet.org/thenews/newsdesk/N1538733.htm
Canada to host big October conference on avian flu
15 Sep 2005 20:20:39 GMT
Source: Reuters
OTTAWA, Sept 15 (Reuters) - Canada will host a major international conference on avian flu in October to discuss how ready the world is to combat a likely pandemic, Health Minister Ujjal Dosanjh said on Thursday.
The head of the U.N. World Health Organization said on Thursday that avian flu will mutate and become transmissible by humans. The flu has already killed more than 60 people in Asia and spread to Russia and Europe.
"We believe that it is important for us across the world to prepare together and know about each other's plans with respect to a possible pandemic," Dosanjh told Reuters.
"For these kinds of issues one is never completely prepared ... we don't know when it (a pandemic) will occur, we all believe it will at some point (and) we need to make sure that we've done all we can to prepare for it."
He said the meeting -- which is most likely to be held in the Canadian capital Ottawa -- would group health ministers and senior officials from around 30 nations.
"We will of course be talking about accelerating global coordination efforts, rapid reaction plans and information sharing," Dosanjh said.
U.S. President George W. Bush on Wednesday unveiled a plan under which countries and international agencies would pool resources and expertise to fight bird flu.
http://www.mercurynews.com/mld/mercurynews/news/politics/12657120.htm
As New Orleans flooded, Chertoff discussed avian flu in Atlanta
BY SHANNON MCCAFFREY, ALISON YOUNG AND SETH BORENSTEIN
Knight Ridder Newspapers
WASHINGTON - (KRT) - Homeland Security Secretary Michael Chertoff, the U.S. official with the power to order a massive federal response to Hurricane Katrina, flew to Atlanta for a previously scheduled briefing on avian flu on the morning after the storm swept ashore.
Chertoff's decision to fly to Georgia for a business-as-usual briefing even as residents in New Orleans fought for their lives in rising floodwaters raises new questions about how much top officials knew about what was happening on the Gulf Coast and how focused they were on the unfolding tragedy.
In fact, Chertoff didn't know for sure that New Orleans' life-preserving levees had failed until a full day had passed.
Not until Chertoff was returning from Atlanta on Aug. 30 did he begin writing the memo that declared Katrina "an incident of national significance" and put the full force of the federal government behind the relief and rescue efforts.
Critics charge that the delay in making the designation until about 36 hours after the storm may have been one reason why federal help was slow in coming and why no one seemed to be in charge in the disaster zone.
In a first accounting of Chertoff's activities before and after the storm, Homeland Security spokesman Russ Knocke portrayed his boss as deeply involved yet not the man in charge.
As the severity of Katrina became apparent on Aug. 26, Knocke said, Chertoff huddled with his staff at Department of Homeland Security headquarters in Washington. Katrina, he said, was a major concern, but not the only thing preoccupying Homeland Security officials.
On Saturday, Aug. 27, Chertoff worked from home and on Sunday, Aug. 28 - with President Bush on vacation in Texas - he spent a long day in his office monitoring the storm's progress, Knocke said. On Monday, Aug. 29, as Katrina made landfall, Chertoff was hobbled by a lack of specific information from officials on the Gulf Coast, Knocke said.
Chertoff's team was unable to confirm until midday on Aug. 30 that the levees had breached even though the flooding was being widely reported on television beginning that morning and officials in Louisiana first reported those breaches in the early morning hours of Monday, Aug. 29.
The Homeland Security chief was "extraordinarily frustrated with some of the scattered information we were getting," Knocke said.
Stung by criticism, Chertoff's aides this week attempted to downplay his importance in managing the disaster relief, saying that former Federal Emergency Management Agency director Michael Brown was in charge. Brown resigned this week amid intense criticism about the sluggish and meager initial response to Katrina.
At the same time, Knocke said, Chertoff was deeply engaged in preparing for and responding to the powerful hurricane - ordering U.S. Customs helicopters to the Gulf Coast on Monday, Aug. 29, as the storm bore down and receiving a steady stream of updates from FEMA. Part of his time in Atlanta was spent at the FEMA operations center there receiving updates on the storm.
"There was a real sense of urgency," Knocke said.
Nonetheless, congressional critics and others are questioning how well Chertoff carried out his responsibilities under the National Response Plan - the blueprint for how the nation responds to disasters.
"There are a lot of questions that ultimately now put more light on the Secretary of Homeland Security," said Rep. Bennie Thompson, D-Miss., the ranking minority member on the House Homeland Security Committee.
Thompson said oversight hearings are needed to resolve them.
FEMA's Brown had arrived in Baton Rouge, La., on Sunday, Aug. 28. By Monday night, Aug. 29, he had called Chertoff and either White House Chief of Staff Andrew Card or his deputy Joe Hagin and said that things were spiraling "out of control," according to an interview Brown gave to The New York Times. Knocke said that Chertoff promised Brown "anything he needed."
Despite Brown's phone call, Chertoff went ahead the next day with his previously scheduled visit to the headquarters for the Centers for Disease Control and Prevention in Atlanta with Health and Human Services Secretary Michael Leavitt for a briefing on avian flu. The disease has killed 57 people worldwide.
Afterward, Chertoff went to FEMA headquarters in Atlanta for an update and it appears that that's when he realized the magnitude of the crisis.
Still critics on Thursday questioned Chertoff's judgment in turning his attention elsewhere, even as the storm damage mounted.
"In the relative scheme of things it (avian flu) needed to be put on the back burner while New Orleans was going under water," said John Copenhaver, a southeastern regional FEMA director under the Clinton administration
Copenhaver found it incredible that Chertoff didn't know water was flooding into New Orleans until Tuesday, Aug. 30.
"He is the Cabinet official of the department that's supposed to know things like this," Copenhaver said.
With the spotlight now on Chertoff, officials at the Department of Homeland Security this week have begun issuing new versions of events surrounding his role in the botched federal response to Katrina.
What they are saying this week contradicts many of their previous statements and actions.
Knocke said Thursday that Chertoff's Aug. 30 memo, first obtained by Knight Ridder, created "an administrative paper trail" for an incident of national significance. He said that the department had been acting "under the auspices of an incident of national significance" since President Bush issued an emergency declaration on Aug. 27, the Saturday before the storm.
But the National Response Plan says that it's the Secretary of Homeland Security who designates an event an incident of national significance. When asked if Chertoff had made the designation earlier than Aug. 30, Knocke refused to answer the question directly.
After Chertoff made the designation in his Aug. 30 memo, federal troops began to file into New Orleans, bringing much-needed supplies to residents. But many people remained stranded on their rooftops seeking help from passing helicopters and boats.
Knocke acknowledged on Thursday that the National Response Plan - which was redrawn after the Sept. 11 attacks and became effective just this year - could be in line for an overhaul.
"We're also going to have to step back and take a look at the playbook," he said.