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Glaxo to Make Flu Vaccine, Gets UK, France Orders

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Viable Swine  Flu Shot  Closer to Reality | EmpowHer - Women's  ... By Michelle Fay Cortez and Trista Kelley

May 15 (Bloomberg) -- GlaxoSmithKline Plc plans to begin production of a swine flu vaccine, preempting a recommendation by the World Health Organization, after four European countries placed orders for the shots.

The U.K., France, Belgium and Finland agreed to buy about 158 million shots from London-based Glaxo and Baxter International Inc. of Deerfield, Illinois, according to statements today from Glaxo and the U.K. government.

The contracts will speed production of an immunization even before health authorities gauge how severe this year's swine flu outbreak will be. A WHO advisory group yesterday said it needed more information about the severity of disease, which has spread across 34 countries and infected 7,520 people, before saying whether companies should start making a vaccine.

"Scientists tell us that as yet we don't know enough about this novel strain, or whether it's likely to mutate, but that this virus has the potential to become a pandemic and we can't predict how serious that would be," U.K. Secretary of State Alan Johnson said today in a statement. "We have an opportunity to secure vaccine in advance of a pandemic wave."

The purchases may be a sign of conflict to come as countries compete for supplies, should the flu spread further and turn more virulent, said David Fedson, an independent infectious disease specialist and former vaccine developer for Sanofi-Aventis SA.

'Moral Right'

"There are political issues here," Fedson said in a telephone interview. "Just because you're first in a queue doesn't mean your people have a moral right to the vaccine."

Four of every 1,000 people infected with the bug in Mexico by late April died, making it more contagious than seasonal flu and rivaling the severity of the 1957 Asian flu pandemic that killed 2 million people, a study in the May 11 edition of the journal Science found.

Glaxo will provide as many as 128 million doses for the European countries, and is in talks with "quite a few" other governments, spokesman Stephen Rea said in an interview. The orders could boost Glaxo sales by about 600 million pounds ($912 million) in 2009, if the shot is priced similar to previous flu vaccines and the company can deliver it by the end of the year, said Simon Mather, an analyst at WestLB AG in London.

Each country has to make its own decision on whether and when to purchase pre-pandemic influenza vaccines, said Marie- Paule Kieny, director of the WHO's initiative on vaccine research, in an e-mailed response to questions. The Geneva-based agency is negotiating to gain access to the immunization for developing countries, she said.

'National Decision'

"This is a national decision," Kieny said. "Too much haste may result in no vaccine being available to low-resource countries, which would go against the WHO recommendation that equity should be a main consideration."

The United Nations health agency estimates that the drug industry can produce at least 1 billion to 2 billion doses of H1N1 pandemic vaccine a year, she said last week.

The WHO declined to comment on how many pandemic vaccine shots the industry can make in a year, and what percentage of that is already committed under deals such as those announced today.

Glaxo plans to start manufacturing the immunization once it receives a so-called "virus seed" from the WHO, essentially the raw material the company will use to develop the vaccine, Glaxo said in a statement. The first doses of the shot should be available four to six months later, pending regulatory approval, the company said.

Baxter Production

Baxter, which uses a different production technology, already received the virus samples it needs and is testing the material to see how well it will grow, said Chris Bona, a company spokesman. The process will take several weeks before the company can start manufacturing, he said.

"Since this is a new virus, overall timelines cannot be projected," he said in a telephone interview.

Sanofi has pandemic vaccine supply agreements with the U.S., Australia, France and Italy, said Albert Garcia, spokesman for Sanofi Pasteur, the company's vaccine joint venture with Merck & Co. The contracts allow for "flexibility" if a pandemic doesn't occur, and Sanofi won't produce vaccine until governments ask them to make it, Garcia said. The Paris-based company is the world's largest maker of seasonal flu shots.

Novartis AG is in talks with governments on possible vaccine stockpiles, Eric Althoff, a spokesman for the company in Basel, Switzerland, said in a telephone interview.

U.K. Order

The U.K. ordered 60 million doses from Glaxo and 30 million from Baxter. Glaxo also got orders for 50 million doses from France, 12.6 million from Belgium and 5.3 million from Finland.

"Because the (A)H1N1 may cause a pandemic, we will stockpile the pre-pandemic vaccine," Rose-Marie Oelander, senior researcher at the National Institute for Health and Welfare in Helsinki, said in a telephone interview today. "If there are a lot of cases in the autumn, we'll be able to use the vaccine when other countries may have to wait for 4 to 6 months."

Glaxo said it will continue to make its seasonal flu shot, and plans to complete the process in July. Seasonal flu infects as many as 5 million people worldwide each year and kills 250,000 and 500,000 of them, according to the WHO's Web site. Most patients experience two to seven days of mild illness, after which they recover without medical treatment.

To contact the reporter on this story: Michelle Fay Cortez

Additional information:

Flu shot : Your best bet for avoiding influenza - MayoClinic.com
Fighting the flu
Age Page: Flu -- Get the Shot
Ontario Ministry of Health and Long-Term Care - Public Information
Preventing the Flu -- familydoctor.org
Obama's Fall Flu Shot
Let's Beat the Flu - Toronto Public Health
Getting the facts - then get your flu shot - Public Health Agency
U.S. officials consider bumping up flu shot season , Health , Reuters
Who Needs a Flu Shot ?

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