Hope rides on "new vaccine"...

[Cat]

July 27, 2006

 

Drug Maker Says New Bird Flu Vaccine Is Much Stronger

 

By DENISE GRADY

 

A new vaccine against bird flu developed by GlaxoSmithKline is more effective than any previous version and works at a far smaller dose, the company reported Wednesday.

 

The ability to immunize people with small doses greatly increases the possibility of making enough vaccine to protect much of the population in the event of a bird flu pandemic.

 

Until now, high dosage requirements have been a major obstacle to making a vaccine for avian flu, worrying public health officials. An earlier vaccine, made a year ago by Sanofi Pasteur and stockpiled by the government, required such large doses that it would be difficult or impossible to make enough to keep up with a pandemic.

 

GlaxoSmithKline said it had tested its vaccine in Belgium in 400 healthy people, ages 18 to 60, who were then given blood tests to measure their immune systems’ response. The tests showed that more than 80 percent of the subjects were protected by two shots, each containing only 3.8 micrograms of an antigen, an immunity-stimulating substance made from the bird flu virus.

 

By contrast, the first Sanofi vaccine protected only about 50 percent of the test subjects, who received two shots with much higher doses, 90 micrograms each.

 

The GlaxoSmithKline vaccine is not yet available, but the company expects to seek approval for it this year from the Food and Drug Administration and from drug agencies in other countries. A spokesman for the F.D.A., Paul Richards, said, “We are encouraged by GSK’s’ promising report,” and added that the vaccine would probably qualify for an accelerated approval process that could be completed in six months or less if the company provided solid data.

 

The vaccine will sell for the same price as a standard flu shot, said Patty Seif, a GlaxoSmithKline spokeswoman. Worldwide, that cost for consumers averages $8 to $12 a shot, she said.

 

But health officials said it was too early to make any recommendations about how and when the vaccine should be used if it reached the market.

 

What sets the new product apart is that it includes an adjuvant, a substance added to stir up the immune system and make the vaccine work better and at lower doses. Alum is a common adjuvant, but it did not provide enough enhancement with bird flu vaccine when tested by Sanofi.

 

The nature of GlaxoSmithKline’s adjuvant is a trade secret, but David Stout, president for worldwide pharmaceuticals at the company, said the ingredients had already been given to people in other products, though not in this particular combination.

 

“How we mix and match is what’s proprietary,” he said.

 

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said GlaxoSmithKline’s findings were “very, very impressive.” But he cautioned that the results were based only on blood tests, not on real-life exposure to the virus.

 

“The proof of the pudding is, how does it work in the field,” he said.

 

He said it would be especially important to find out if the vaccine still worked if the bird flu virus began to change genetically. It is too early, he added, to say what the government’s plans might be for buying and stockpiling this vaccine.

 

Dr. David Nabarro, chief pandemic flu coordinator for the United Nations, said: “Certainly this is welcome, but we’ve only had a press release. It’s very difficult for any of us to comment in more than general terms. We look forward to finding out more about safety and efficacy.”

 

Dr. Irwin Redlener, head of the National Center for Disaster Preparedness at Columbia University, said, “This is very promising technology, but what is still not known is how well this vaccine will work on whatever the actual strain is that produces a pandemic.”

 

Even so, he said, it would make sense for the government to stockpile about 40 million doses of the GlaxoSmithKline product and start using it if a pandemic began. If the vaccine worked, more could be made; if it did not, crash production of another vaccine would be needed.

 

Flu pandemics occur when people encounter new viral strains to which they have no immunity. The bird flu virus now spreading around the world, known as A(H5N1), is such a strain, but so far it has not managed to spread easily to people or between them. If it were to mutate in a way that made it more contagious among people, a deadly pandemic could erupt. In that case, countries all over the world will be clamoring for a vaccine.

 

But, Dr. Nabarro warned, yet another new virus, totally unrelated to A(H5N1), could pop up, and in that case the current vaccines will be useless. The A(H5N1) virus could also mutate enough to make the vaccines obsolete, he said.

 

“We’re a long way away from seeing this vaccine being part of the pandemic preparedness strategy for governments, but it’s welcome news and likely to be a step in the right direction,” he said.

 

Mr. Stout said the company had not yet met with government officials in any country to make plans for the use of the vaccine.

 

He said that GlaxoSmithKline’s current production capacity for seasonal flu vaccine is 60 million to 70 million doses a year, and that it could make an equal amount of the bird flu vaccine. By 2008, it expects to be able to make 150 million doses a year. But those amounts can vary considerably depending on the exact viral strain being used to produce flu vaccine, and how easy it is to grow.

 

The A(H5N1) virus has spread rapidly through birds in Asia, Europe and Africa in the last few years. The virus attacks mainly birds, but some humans have been infected, mostly through contact with birds. So far, the disease has been highly lethal in people, killing more than half its victims. It seems rarely if ever to spread from person to person, but that could change.

 

Since 2003, 232 people in 10 countries have contracted bird flu, and 134 have died. The worst current outbreak is in Indonesia, where many thousands of birds have been infected, 54 people have contracted the disease, and 42 have died.

 

NY Times - new Bird Flu vaccine

[Cat]

(SECOND ARTICLE)

 

Jul 26, 6:59 PM EDT

 

Bird-Flu Vaccine May Be Ready by Next Year

 

By MARIA CHENG

AP Medical Writer

 

LONDON (AP) -- A British company reported Wednesday it had achieved the best results ever seen on an experimental human vaccine for bird flu and said mass production might be possible by 2007.

 

A global health official called GlaxoSmithKline's early results "an exciting piece of science." If future tests are as promising, it would be a major step in the frustrating campaign to protect people from a possible deadly flu pandemic.

 

The U.S. government's chief infectious disease scientist also was very optimistic.

 

"The data are really very impressive," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "It changes the whole complexion of the issue that we have to face of getting enough vaccine for people who might need it in a pandemic."

 

Glaxo's results came from tests on 400 people in Belgium, most of whom developed strong immune responses from very low doses of the prototype vaccine.

 

Success from wider tests of the vaccine could intensify competition with Sanofi-Aventis SA, whose vaccine unit, Sanofi Pasteur, reported disappointing results in March on its experimental product. It protected only about half of those who got two shots with a very high dose - 90 micrograms of the key ingredient.

 

Glaxo said two shots of its vaccine provoked strong responses in more than 80 percent of people tested at lower doses than other experimental bird flu vaccines are using. Some received as little as 3.8 micrograms, said Fauci, who has seen the test results on the vaccine.

 

"It's pretty strong," he said.

 

The Glaxo vaccine includes an immune-system booster that allows it to use less of the main active ingredient, meaning that greater quantities could be produced if the H5N1 bird virus mutates into a form that spreads easily among people and causes a global epidemic. The vaccine uses an inactivated version of the newer strain of H5N1, which was isolated in Indonesia last year.

 

"It's a good and exciting piece of science," said Dr. David Nabarro, the United Nations' coordinator for avian and pandemic influenza. "But as with all new discoveries, quite a lot of work has now got to be done to establish its place in public health and pandemic preparedness."

 

Sanofi and another vaccine maker, Chiron Corp., also have been experimenting with ingredients called adjuvants to boost effectiveness. Glaxo's results, which were announced by the company but have not yet been published in a medical journal, are the best success reported so far with this approach.

 

"This is very significant," said Dr. Albert Osterhaus, head of the virology department at Erasmus University in the Netherlands. "With this adjuvant added to the vaccine, provided the rest of the tests are OK, you could make 10 times as much vaccine."

 

Glaxo's chief executive officer, J.P. Garnier, said the preliminary findings validate this approach, and that the company expects to seek regulatory approval "in the coming months."

 

While cautioning that it's still early in the testing, some pandemic flu experts are optimistic that this may ultimately lead to production of many more doses of pandemic vaccine.

 

However, Dr. Klaus Stohr, a World Health Organization flu vaccine adviser, said it would have been better if the adjuvant was a substance widely available to other companies rather than a Glaxo company product.

 

"Access for other companies to use it will most likely be limited," he said.

 

More than 20 clinical trials involving potential H5N1 vaccines are being underaken by more than 30 companies.

 

Glaxo's success also would not guarantee that all people and countries would be protected in the event of a flu pandemic. Flu viruses mutate so readily that it may ultimately be a different strain of the virus that threatens people.

 

"It's a risk judgment for those potentially purchasing vaccine," said Dr. Angus Nicoll, influenza coordinator at the European Center for Disease Prevention and Control. Because it is impossible to predict which influenza strain will spark the next pandemic, "it's a very difficult decision for a country to decide whether to invest in pandemic vaccines," he said.

 

In May, the U.S. government awarded more than $1 billion to five companies, including Glaxo, which are developing faster ways to mass produce vaccine in case of a pandemic. The government also has ordered millions of dollars worth of Aventis' experimental vaccine to stockpile in case bird flu starts spreading more easily from person to person.

 

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AP Medical Writer Marilynn Marchione contributed to this report from Milwaukee.

 

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Bird flu vaccine

[Becca_Anne]

There is only one problem with this- the vaccine works against the current avain flu strain. If the virus changes to make it easily transmissible to humans, the vaccine they have won't work againt the new strain! It is progress, I just object to the misrepresentation by the vaccine maker that this will actually protect a person from the bird flu if it goes pandemic.

[anyala]

I agree Becca Anne,

Every year people get vaccinated with a flu vaccine, but everyone I know who does it always gets the flu anyway. These vaccines only protect against one type of strain, and there are over 200 different ones. Who knows what kind of strain the bird flu will produce. Part of me feels that these vaccines are just another way for the pharmacutical companies to make money off of unsuspecting, worried citizens.

 

Anyala

[Cat]

People who have been waiting for technology to "fix the problem" will say "OK, we're safe... no worries!" and go on their various merry ways.

 

So someone creates another vaccine... the "proof's in the pudding". Until it comes, no one knows if it will work on *that* strain.

 

 

[mistylady]

I hate to be the bad guy here but the flu vaccine has thimerosal (mercury) in it. They say it isn't enough to harm you but mercury is one of those cumulative things (it builds up). One of the states (Idaho or Iowa - I can't remember and my computer is acting beastly by locking up often) has banned all shots that contain this when it comes to kids vaccines. I don't know about adults. Someone thats computer is happy with them might look.

 

If they make ten shots in a year trying to get the right strain in hand - that's ten doses of the stuff. Keep yourself healthy by staying fit, washing your hands often and you're on your way to staying flu-free! Since my son was a premie we had to take special precautions with his health. No visitors for a year and we washed our hands and used germ killer often. Thank God he never got sick. Neither did any of the rest of us! DH works with people who got the flu even though they got the shot - dh didn't get the shot and never got the flu even after being on the same shift and same area as the sick people. Guen will be three in dec and with all the praise going where it belongs (God) she has never even had a sniffle.

 

Take care of yourselves and your loved ones.