Gert van der Hoek
In Memoriam - Editor, Senior Moderator
European agency endorses Baxter's bird flu vaccine
By Bruce Japsen | Tribune staff reporter
December 18, 2008
Baxter International Inc.'s vaccine to combat the bird flu today won an endorsement from European health officials.
It's a dose of good news for the Deerfield-based medical product giant and countries around the world that have been stockpiling the product without a government-approved clearance about the vaccine's safety or effectiveness.
Baxter this afternoon said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a "positive opinion" for Baxter's Celvapan, a vaccine against H5N1 strains of avian influenza, also known as bird flu. The committee's endorsement is generally a precursor to approval by the European Union.
An eventual clearance by European health officials should help win approval in the U.S. as well. Such approvals allow for the products to be marketed broadly as being safe and effective.
Although the spread of the bird flu has slowed, cases continue to emerge around the world. Since 2003, there have been 391 cases of Avian flu in humans and 247 deaths, largely in Asia along the Pacific Rim, according to the World Health Organization's Web site.
Because of limited manufacturing capacity for vaccines, several countries, including the U.S., have stockpiled Baxter's vaccine along with bird flu vaccines made by other companies in the event of a pandemic outbreak. In Europe, the United Kingdom and Austria signed contracts to stockpile Baxter's vaccine and that made of other companies.
"This is another step toward our goal of supplying a safe and effective vaccine to protect the population against a possible influenza pandemic," said Dr. Hartmut Ehrlich, vice president of Baxter's Bioscience global research and development.
Celvapan has other benefits. Unlike the traditional decades-old, egg-based production used by other flu vaccine-makers, Baxter uses a cell-based technology that can produce vaccines quicker and in large quantities. The method could enable Baxter to produce dosages faster in the event of a flu pandemic, the company has said.
Baxter is also in final stage clinical trials for a vaccine to prevent seasonal influenza that uses the company's cell-based technology, which could help boost production and prevent flu vaccine shortages that have arisen in recent years.
Baxter has not disclosed specific amounts of revenue generated but its third quarter financial report lumped vaccine sales in a line item called "other" that contributed $89 million to the company's $1.35 billion in bioscience sales. Total Baxter sales in the third quarter were about $3.2 billion.
http://www.chicagotribune.com/business/chi-biz-baxter-bird-flu-vaccine-dec18,0,567144.story
By Bruce Japsen | Tribune staff reporter
December 18, 2008
Baxter International Inc.'s vaccine to combat the bird flu today won an endorsement from European health officials.
It's a dose of good news for the Deerfield-based medical product giant and countries around the world that have been stockpiling the product without a government-approved clearance about the vaccine's safety or effectiveness.
Baxter this afternoon said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a "positive opinion" for Baxter's Celvapan, a vaccine against H5N1 strains of avian influenza, also known as bird flu. The committee's endorsement is generally a precursor to approval by the European Union.
An eventual clearance by European health officials should help win approval in the U.S. as well. Such approvals allow for the products to be marketed broadly as being safe and effective.
Although the spread of the bird flu has slowed, cases continue to emerge around the world. Since 2003, there have been 391 cases of Avian flu in humans and 247 deaths, largely in Asia along the Pacific Rim, according to the World Health Organization's Web site.
Because of limited manufacturing capacity for vaccines, several countries, including the U.S., have stockpiled Baxter's vaccine along with bird flu vaccines made by other companies in the event of a pandemic outbreak. In Europe, the United Kingdom and Austria signed contracts to stockpile Baxter's vaccine and that made of other companies.
"This is another step toward our goal of supplying a safe and effective vaccine to protect the population against a possible influenza pandemic," said Dr. Hartmut Ehrlich, vice president of Baxter's Bioscience global research and development.
Celvapan has other benefits. Unlike the traditional decades-old, egg-based production used by other flu vaccine-makers, Baxter uses a cell-based technology that can produce vaccines quicker and in large quantities. The method could enable Baxter to produce dosages faster in the event of a flu pandemic, the company has said.
Baxter is also in final stage clinical trials for a vaccine to prevent seasonal influenza that uses the company's cell-based technology, which could help boost production and prevent flu vaccine shortages that have arisen in recent years.
Baxter has not disclosed specific amounts of revenue generated but its third quarter financial report lumped vaccine sales in a line item called "other" that contributed $89 million to the company's $1.35 billion in bioscience sales. Total Baxter sales in the third quarter were about $3.2 billion.
http://www.chicagotribune.com/business/chi-biz-baxter-bird-flu-vaccine-dec18,0,567144.story
