Entries in H5N1 (6)


FDA Panel OKs Bird Flu Vaccine Stockpiling

iStockphoto/Thinkstock(WASHINGTON) -- A vaccine for the H5N1 avian flu, or bird flu, has been approved by a panel of experts to be stockpiled for emergency use in case of a pandemic.

A U.S. Food and Drug Administration advisory panel voted 14-0 in favor that the vaccine, manufactured by GlaxoSmithKline (GSK) in Quebec, was in compliance with licensing standards under accelerated approval regulations, reports MedPage Today.

H5N1 currently does not spread as easily among humans as it does among domestic foul, but flu experts have feared it could mutate and potentially lead to a pandemic. In infected humans, the virus is highly dangerous. The World Health Organization says since 2003, there have been 608 bird flu cases -- 359 of those cases resulted in death, according to MedPage.

Although the FDA isn't required to follow through with the advisory panel recommendations, it generally does, MedPage reports.

GSK, who has worked with the U.S. Department of Health and Human Services in developing the H5N1 vaccine, is hoping the agency will move forward on the panel's approval to stockpile the vaccine.

"We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the U.S. Government on public health issues," Glaxo VP of vaccine discovery and development, Bruce Innis said in a statement.

GSK says that in clinical trials, the most common side effects of the vaccine include pain at the injection site, swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating.

Copyright 2012 ABC News Radio


Controversial Deadly Bird Flu Research Finally Published

Stockbyte/Thinkstock(NEW YORK) -- After months of controversial government assessment, the journal Nature published research Wednesday that discloses methodology behind creating a deadly strain of bird flu that could kill millions.

By conducting research in ferrets, a team of Japanese and U.S. researchers found that it would take four mutations of the bird flu virus for the strain to successfully spread from birds to mammals. The research comes after months of delay because of arguments that pitted the cause of medical preparedness against the dangers of disclosing information that could help bioterrorists.

The study is the first of two research papers that discuss the methodology behind creating deadly avian flu strains that have potential to kill millions.

“Currently, we do not know whether the mutations that we identified in this study that allowed the [study strain] virus to be transmissible in ferrets would also support sustained human-to-human transmission,” study authors wrote. “In particular, we wish to emphasize that the transmissible [study strain] virus possesses seven segments [all but the HA segment] from a human pandemic 2009 H1N1 virus.”

The second paper, which will be published in the journal Science, discusses the methodology behind a deadly H5N1 strain created in a Dutch laboratory at the Erasmus Medical Center in Rotterdam by scientist Ron Fouchier.

The team, headed by Yoshihiro Kawaoka of the University of Wisconsin-Madison, submitted the paper last year to the journal, but publication was delayed after the U.S. National Science Advisory Board for Biosecurity made the unprecedented decision to assess the findings prior to publication. But, in a commentary published Wednesday, Nature editors noted that “a paper that omits key results or methods disables subsequent research and peer review....We cannot imagine any mechanism or criterion by which to sensibly judge who should or should not be allowed to see the work.”

They also remarked, “Where there is a benefit to public health or science, publish!”

Since it appeared in 1996, H5N1 has killed hundreds of millions of birds, but transmission to humans has been rare. There have been about 600 confirmed cases of infections in people, mostly people who worked directly with poultry. While rare, it is a deadly human disease. About 60 percent of those who had confirmed cases of the virus died.

Up until now, experts believed that the strain was transmissible from person to person only through very close contact, but Fouchier mutated the strain, creating an airborne virus that could be easily transmitted through coughs and sneezes.

“Research into how flu viruses change, how they develop the ability to infect different species, is critically important for preparing for pandemics,” said Dr. Richard Besser, chief medical editor at ABC News. “It helps you predict what the next pandemic might be and to develop new vaccines.”

The dilemma is that this sort of research has dangers, Besser said. But manipulating the genome of microorganisms is now something even a talented high school student can do.

“The fear is that terrorists will take the lessons from this kind of research and use it to deliberately cause disease,” said Besser. “How you balance the importance for public health with the potential for harm is extremely challenging.”

Experts contacted by ABC News in December were split on whether the research should be published. While most virologists believe in non-censorship for the good of public health, some talked about the potential danger of releasing information on a virus that was so easily mutated.

“The idea that biosecurity consists in policing scientists or chimerical ‘bioterrorists’ is dangerous nonsense,” said Philip Alcabes, a professor in the CUNY School of Public Health at Hunter College. “Who knows what the motives of the self-professed biosecurity experts really are, but in practice, their ridiculous pronouncements promote vast expenditures of taxpayer monies that achieve little outside of propping up the very biosecurity industry from which the warnings come.”

“Censorship offends me, particularly in science,” John Barry, author of The Great Influenza, said in December. “Nonetheless, I think there should be review of something like this...but not necessarily by the government. It should be done by people who respect scientific openness, and publishing should be the default position.”

Copyright 2012 ABC News Radio


Researchers Pause Work on Bird Flu That Could Kill Hundreds of Millions

Comstock/Thinkstock(ROTTERDAM, Holland) -- It is the stuff of science fiction: scientists tamper with a killer bird flu virus and create something much worse. But what has been created in a Rotterdam laboratory is not fiction. It is deadly real.

So deadly that the U.S. government -- which funded the Rotterdam research -- asked scientists to omit key details of their research when they are published to keep the formula out of the hands of bio-terrorists. And Friday, researchers announced a self-imposed 60-day "voluntary pause" on any research involving highly transmissible form of bird flu that they have created.

The researchers are responding to the worldwide furor that erupted after word of their work became public. There are serious public health reasons for the research and they want to lower the temperature of the discussion while they explain what they have done and why they have done it.

The lead author of Friday's announcement is Dr. Ron Fouchier, a respected molecular virologist. He heads at Erasmus Medical Centre in Rotterdam, in the Netherlands, that engineered a form of "aerosolized" bird flu that can easily be passed from humans to humans through the air. The genetically-altered flu is thought to be so virulent that if the vials containing it were to get out, the virus would have the potential to spread around the globe and kill hundreds of millions.

Bird flu, also known as H5N1, first surfaced 15 years ago. It has not caused mass panic because it is only transmitted to humans who have direct contact with infected birds. But when humans do contract bird flu, they are likely to die.

According to the World Health Organization of 573 confirmed bird flu cases in humans since 2003, 336 people have died. That's a staggering 60 percent mortality rate. Nothing in history comes close to that.

ABC News was given an exclusive inside look at some of the testing facilities the Rotterdam researchers used. With Fouchier as the guide, ABC News' Jeffrey Koffman donned protective clothing and a face mask and passed through three levels of security to see the ferrets he uses for testing.

Fouchier explained how his lab assistants exposed the ferrets to the altered virus and placed unexposed ferrets in cages nearby. All 40 ferrets died. Scientists use ferrets because they have a respiratory system much like humans, which is why the researchers believe the consequences of an airborne bird flu would be just as deadly for humans.

No visitors, however, are allowed in the high secret lab at Erasmus Medical Centre where the actual experiment took place. He told ABC News that with U.S. and Dutch expertise, Erasmus spent eight years and millions of dollars building one of the most secure lab facilities in the world just for studying H5N1. They call it a BSL3 Enhanced lab -- that's Bio-Safety Level 3. The vials of enhanced bird flu are kept in a bank vault inside the lab. The lab is designed to keep the deadly virus in and intruders out.

The researchers who engineered this super-virus insist they are far from being "mad scientists" as some have suggested. They are public health specialists.

The man in charge, Fouchier is a tall, lanky molecular biologist who began his career studying HIV in Philadelphia, but switched to bird flu when the mysterious virus first surfaced in 1997.

"What scares me is that this can happen so easily," he says, "it's scary that it might actually happen in the field."

And that's the point behind research that on the surface seems insane to some. Fouchier says what he did in the lab was mutate a few genes. That happens regularly in nature.

Fouchier insists the dangerous part of this virus isn't what he has created in the lab, it is what can happen if nature creates something similar. He says this should be a wakeup call for public health authorities around the world.

In the history of epidemics and pandemics nothing has been as lethal as the bird flu Fouchier has created. The most deadly epidemic of the last century was the Spanish Flu outbreak of 1918. Virtually everyone in the world was infected. It is estimated that between 50 and 100 million people died -- conservatively that means it killed 3 percent of those infected. In a globalized world of air travel and mass transit, the prospect of an airborne bird flu with a 60 percent death rate is terrifying.

At its peak in 2006 bird flu was found in 63 countries, most of them in Asia. The Bush Administration was so concerned about the potential threat to humans from an airborne mutation that it contracted labs in the U.S. and overseas to see if such a human-to-human form really could evolve. The Dutch scientists were the first to prove it is possible. A lab at the University of Wisconsin-Madison has independently created a similar form of the lethal virus.

Since it peaked six years ago, H5N1 bird flu has been eradicated in many countries, but it remains endemic in Bangladesh, China, Egypt, India, Indonesia and Vietnam. Fouchier says one of the main reasons the U.S. and other Western governments were eager to see if the super-virus could be created was to push the countries where bird flu still exists to take the threat seriously.

"The urgency to eradicate bird flu in poultry markets [in those countries] was not very high," says Fouchier, "With these experiments we tell these countries please eradicate this virus very aggressively to prevent a pandemic."

"My first reaction was 'Oh, my God, why did they do this?'" says Laurie Garrett, Senior Fellow for Global Health at the Council on Foreign Relations. "Second reaction was, 'Oh dear, it works!' Meaning that nature could do the same thing -- that they had proven how dangerous the virus could be. And then my final reaction was, 'We have no capacity to control this kind of work. Our treaty systems our policy systems, will not do the job.'"

Garrett wonders whether the science can be justified. "We have a whole legacy now of labs doing experiments that in the wrong hands could be very, very dangerous. I'm not real comfortable with having this virus exist -- anywhere."

But when ABC News surveyed virologists in the United State for their opinions on the value of such seemingly toxic science the overwhelming response was that Fouchier's work is a valuable contribution to public health around the world.

"I think it's a very good idea," says Dr. William Schaffner, Chairman of the Department of Preventive Medicine at Vanderbilt University in Nashville. "We need to know more about how it is that influenza viruses that start out often in birds can transfer their capacity to make illness in humans and that essential research is going on in Rotterdam."

Schaffner says if affected countries do not move to eradicate bird flu and public health officials are not prepared for the appearance of a highly lethal airborne strain of the bird flu virus, the consequences could be horrifying. "If we were to have a pandemic caused by this virus in nature, then we are talking about millions of people being ill around the world, hospitals overflowing with sick people, funeral homes not being able to keep up with the deaths. So we need as much scientific information as possible to avert that."

Fouchier is scheduled to publish his findings in the journal Science. He has agreed to omit key details from the paper so that anyone thinking of replicating the virus will not have access to his blueprint. But he notes, the flu virus is hardly an effective form of bioterrorism. What he did is highly technical, requiring skills and equipment that are not widely available. He says nature produces much more accessible biological menaces on its own, although he is quick say he will not name them.

His bigger concern is that the outcry over his research will shut down an important branch of public health research -- not just for 60 days, but for good.

"If politics were to shut down this type of research then what we should do is lie in the sun until the next pandemic hits and kills us," he says. "That, I think, is not the attitude we should follow. Unless that is what we want we have to do this type of research. Otherwise we will be overwhelmed by Mother Nature terrorizing us in the future."

Copyright 2012 ABC News Radio


WHO ‘Deeply Concerned’ by Lab-Created Bird Flu Mutation

Ingram Publishing/Thinkstock(NEW YORK) -- The World Health Organization (WHO) says it is “deeply concerned” about researchers creating a more contagious and fatal form of the H5N1 bird flu.

Researchers in the Netherlands have manipulated the virus to make it more transmissible among humans, and it could potentially kill millions if released into the public.

The findings were set to be released in the U.S. journal Science, but the National Science Advisory Board for Biosecurity, an independent committee that advises the U.S. Department of Health and Human Services and other federal agencies, reviewed it last Tuesday and warned that bioterrorists could replicate the study methods to create a weapon of biological warfare.

On Friday, the WHO echoed the agencies’ sentiments by saying that the studies could open the door to “possible risks and misuses.”

The current H5N1 strain is more often found in birds and not easily transmissible to humans. Hundreds of millions of birds have died from the virus since it was first identified in 1996. By comparison, only an estimated 600 people have been infected. About 60 percent of those who get the bird flu die, according to the WHO.

Ron Fouchier of Erasmus Medical Center in Rotterdam, Netherlands, said he created the contagious form of the deadly H5N1 bird flu strain “easily” by mutating a few genes within the strain. He agreed to exclude methodology details from his published reports on the new strain.

“We know which mutation to watch for in the case of an outbreak, and we can then stop the outbreak before it is too late,” Fouchier said in a statement on the medical center’s website. “Furthermore, the finding will help in the timely development of vaccinations and medication.”

Fouchier is one of many researchers worldwide looking at what kind of mutations would make the H5N1 more dangerous to humans.

In May, the WHO member countries adopted a Pandemic Influenza Preparedness Framework which set rules on sharing information about flu viruses that have pandemic potential.

“While it is clear that conducting research to gain such knowledge must continue, it is also clear that certain research, and especially that which can generate more dangerous forms of the virus than those which already exist, has risks,” the WHO said in a public statement.

Copyright 2011 ABC News Radio


US Blocks Publication of Research on Highly Contagious Bird Flu Strain

iStockphoto/Thinkstock(ROTTERDAM, Netherlands) -- Researchers in the Netherlands have created a mutated, highly contagious form of the deadly H5N1 bird flu strain that some fear could kill millions if it were unleashed on the general public. The U.S. government worries that publishing the methodology behind the strain's creation could heighten its potential for use as a weapon of biological warfare.

Virologist Ron Fouchier, who carried out his research at the Erasmus Medical Center in Rotterdam, said in a statement that he hoped his research would assist in developing better vaccines and treatments for influenza in the future. Fouchier did his research on ferrets, whose immune response to influenza is similar to that of humans.

"We know which mutation to watch for in the case of an outbreak, and we can then stop the outbreak before it is too late," Fouchier said in a statement on the medical center's website. "Furthermore, the finding will help in the timely development of vaccinations and medication."

The study results were to be published in the U.S. journal Science, but the National Science Advisory Board, an independent committee that advises the U.S. Department of Health and Human Services and other federal agencies, reviewed it Tuesday and warned that bioterrorists could potentially misuse the published research "for harmful purposes."

Fouchier declined to comment beyond his online statements, and the Erasmus Medical Center press office referred reporters to the National Science Advisory Board for Biosecurity's statement until further decisions had been made regarding publication of the research.

The National Institutes of Health, which funded the research, said Fouchier and his team would make changes to the manuscript before it was published in scientific journals.

Copyright 2011 ABC News Radio


Bird Flu is Back, FAO Warns

Jupiterimages/Thinkstock(ROME) -- A new strain of avian H5N1 influenza, also known as bird flu, has surfaced, the Food and Agriculture Organization (FAO) said Monday.  The vaccine-resistant viral strain has shown up in flocks of poultry in both China and Vietnam, the FAO said, according to MedPage Today.

"In Vietnam, which suspended its springtime poultry vaccination campaign this year, most of the northern and central parts of the country -- where H5N1 is endemic -- have been invaded by the new virus strain, known as H5N1-," FAO cautioned in a statement Monday.

While cases of human infection have not been reported, according to the World Health Organization, the FAO warned that spread of the strain could present "unpredictable risks to human health," MedPage Today reports.

Cases of the bird flu epidemic were cut down in 2008 after countries impacted by the virus slaughtered scores of afflicted poultry flocks.  But new flare-ups surfaced, causing numbers of cases to jump to almost 800 in January 2010 from 300 in 2008, Medpage reports.

Now virus-stricken poultry cases have been reported in Bulgaria, Romania, Palestinian territories and Israel.

Human bird flu cases amount to 565 globally, with 331 deaths since 2003, according to the WHO.

Copyright 2011 ABC News Radio

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