Vaccine for bird flu works at low doses, Baxter says

[Sally Furniss]

Vaccine for bird flu works at low doses, Baxter says

Bloomberg News
Posted Friday, March 30, 2007


Baxter International Inc. said Thursday small doses of its experimental vaccine against the bird flu spreading in Asia were safe and effective in a human study, spurring the comp any to begin final testing.

Vaccinations for the new study, the last of three phases of research needed for U.S. approval, will start before the end of June and results are due by year-end, the Deerfield- based company said in a prepared release.

Findings showed the vaccine induced protection against multiple strains of the H5N1 bird flu that were taken from patients in Vietnam. The study also indicated that the vaccine may not need a booster, helping keep costs down for poorer countries, since small doses proved to be effective.

Final testing is designed to ?confirm these findings and provide a solid measure of the vaccine?s potential to protect a large number of people before and during a possible pandemic,? said John Oxford, professor of Virology, The Queen Mary School of Medicine, London, United Kingdom, in the statement.

Side effects, including headache and fatigue, were minimal and occurred at rates similar to those reported for licensed vaccines already used for seasonal flu shots.

GlaxoSmithKline PLC, the London-based vaccine maker, said in July that an adjuvant, or booster, helped its vaccine protect against strains of bird flu. Novartis AG, based in Basel, Switzerland; MedImmune Inc., based in Gaithersburg, Md.; Paris-based Sanofi-Aventis SA; and Australia?s CSL Ltd. are also developing H5N1 vaccines.

The H5N1 bird flu has spread from Asia to Africa, the Middle East and Europe, and more than 200 million birds have been killed by the virus or culled to prevent its spread. At least 284 people have caught the virus, mostly through close contact with birds and 169 of them have died.

 

[Snowy Owl]

Re: Vaccine for bird flu works at low doses, Baxter says

Baxter says bird flu vaccine working for humans in trials
http://www.chicagotribune.com/business/chi-070329baxter,0,421829.story?coll=chi-business-hed

By Bruce Japsen
Tribune staff reporter
Published March 29, 2007, 1:11 PM CDT

​

Baxter International Inc. today said its bird flu vaccine is working for humans against several strains of the virus at low dosages, setting the stage for a final round of testing the company expects to complete by the end of this year.

The progress in testing its vaccine against strains of the H5N1 virus could help Baxter as it negotiates with countries around the world trying to protect their citizens from a possible bird flu pandemic. Meanwhile, the continued progress of testing should provide consumers with more confidence considering there is no commercially available bird flu vaccine as countries begin to stockpile product that has been government approved.

Shares of Baxter rose 34 cents to $53.10 in early afternoon trading on the New York Stock Exchange.

Baxter's trials have shown the vaccine to work in 76 percent of those tested. The company also said its vaccine was tested without using so-called "adjuvant," an additive being used by some other companies that is believe to cause side effects.

"What's important about Phase I/II data is that the results show that Baxter's vaccine works against many strains of the H5N1 avian flu virus without any additives [adjuvant] to boost effectiveness," said Baxter spokesman Chris Bona. "Additives can add additional cost and they are believed to cause side effects" such as headache and fever, he added.

At least one other company known to disclose results of its testing is British drug giant GlaxoSmithKline PLC, which said last year that an adjuvant helped its vaccine work against bird flu strains.

But Baxter said in a statement that side effects observed in the trial were "injection site reactions, headaches and fatigue." The company said there were "minimal" occurrences of such side effects, which were "similar to those reported for licensed egg-based, seasonal influenza vaccines."

Baxter is leading the development of a newer cell-based technology, which allows the company to make vaccines more quickly in larger quantities. For decades, technicians have injected strains of virus into millions of chicken eggshells by hand in a laborious, months-long process.

Last year, Baxter won a contract from the United Kingdom to make more than two million doses of a cell-based vaccine British health officials hope to use as a preventive for avian influenza.

But Baxter executives said other governments it has talked to are cautious about stockpiling because it is difficult to predict whether the product they are buying would work against the particular strain of the H5N1 virus that may hit their country

 

[Snowy Owl]

Re: Vaccine for bird flu works at low doses, Baxter says

Baxter Puts Out Info On Flu Vaccine

http://www.ecanadanow.com/science/health/2007/03/29/baxter-puts-out-info-on-flu-vaccine/​

Boston (eCanadaNow) - Baxter International Inc. released results from their vaccine to fight the avian flu.

Clinical trials were held in the midstages and so far have showed extremely positive results. This caused a rise in stock shares for Baxter raising the stock by 36 cents to $53.12 on the New York Stock Exchange.

The trial results are from Phase one and two and showed that the drug is very effective at righting the avian flu in low doses.

It also proved to be very potent against various H5N1 strains which may occur.

A Phase III trial is set to begin in Europe by the end of 2007. The final trial will confirm the results already in place and if all goes as planned we could be looking at a new and highly effective vaccine.
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[Treyfish]

Re: Vaccine for bird flu works at low doses, Baxter says

Taken from the vietnam strain. Company says bird flu vaccine working

By BRUCE JAPSEN

Chicago Tribune

<!-- begin body-content -->CHICAGO - Baxter International Inc. on Thursday said its bird flu vaccine is working for humans against several strains of the virus at low dosages, setting the stage for a final round of testing the company expects to complete by the end of this year.
The progress in testing Baxter's cell-based vaccine against strains of the H5N1 virus could help the Deerfield, Ill.-based medical products giant as it negotiates with countries around the world trying to protect their citizens from a possible bird flu pandemic. It has a few contracts, but some countries have been asking for more evidence the product works before signing any deals.
What's more, the continued progress of testing should provide consumers with more confidence, considering there is no commercially available bird flu vaccine. Bird flu vaccines being developed by Baxter and other companies and stockpiled have not been government-approved.
Baxter is among about a half-dozen vaccine makers in various stages of testing their products against the H5N1 strain of avian influenza that has killed 170 people, mostly in Asia. Baxter said its product is the first cell-based vaccine in clinical trials.
Baxter is leading the development of cell-based technology, which allows the company to make vaccines more quickly in larger quantities. For decades, technicians have injected strains of virus into millions of chicken eggshells by hand in a laborious, monthslong process.
"A good safety profile and cross immunity against multiple viral strains is critically important for governments considering the concept of using a vaccine before, or immediately after, a pandemic breaks out," said Dr. Hartmut Ehrlich, vice president of global research and development for Baxter's Bioscience business.
Baxter's trials have shown the vaccine to work in 76 percent of those tested.
The company also said its vaccine was tested without using so-called "adjuvant," an additive being used by some other companies that is believed to cause side effects. The findings unveiled Thursday come from study of 270 patients from Europe and Asia. Strains of the virus were taken from patients in Vietnam.
"What's important about Phase I/II data is that the results show that Baxter's vaccine works against many strains of the H5N1 avian flu virus without any additives (adjuvant) to boost effectiveness," said Baxter spokesman Chris Bona.
"Additives can add additional cost, and they are believed to cause side effects" such as headache and fever, he added.
At least one other company known to disclose results of its testing is British drug giant GlaxoSmithKline PLC, which said last year that an adjuvant helped its vaccine work against bird flu strains.
But Baxter said in a statement that side effects observed in the trial were "injection site reactions, headaches and fatigue." The company said there were "minimal" occurrences of such side effects, which were "similar to those reported for licensed egg-based, seasonal influenza vaccines."
In the next two months, Baxter will begin enrolling more than 600 patients in the final clinical trial. This time, each will get the same 7.5-microgram dosage without adjuvant, rather than past testing that has involved some patients receiving larger dosages as well as vaccine that includes adjuvant.
The lower dosage of vaccine is considered important should there be an outbreak because companies might be required to quickly ramp up manufacturing capacity and increase the possibility that a greater number of people can be immunized.
Last year, Baxter won a contract from the United Kingdom to make more than 2 million doses of a cell-based vaccine British health officials hope to use as a preventive measure for avian influenza. The company has also signed stockpile agreements with an undisclosed number of other countries, but said those health ministries do not want their names released publicly.
Baxter executives said other governments it has talked to are cautious about stockpiling because it is difficult to predict whether the product they are buying would work against the particular strain of the H5N1 virus that might hit their country. The progress of Baxter's vaccine in clinical trials will help in negotiating more contracts, said Noel Barrett, Baxter's vice president of research and development for the company's vaccine business.
The price of Baxter stock rose 46 cents a share, to $53.22, on the New York Stock Exchange. The company's share price has jumped more than 40 percent over the last year. http://www.montereyherald.com/mld/montereyherald/business/16999560.htm