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Glaxo to Test Bird Flu Vaccine in Singapore, Thailand, Taiwan
http://www.bloomberg.com/apps/news?pid=20601202&sid=a3eaKHGpTxvE&refer=healthcare
By Jason Gale
May 7 (Bloomberg) -- GlaxoSmithKline Plc, the world's second-largest drugmaker, will test its experimental bird flu vaccine on about 1,000 people in Singapore, Taiwan, Thailand and Hong Kong to gauge its effectiveness in Asians, an official said.
Recruitment for the study -- the final of three stages of clinical trials usually needed for a drug to be approved in the U.S. -- has started in Singapore, said Graeme Hacking, a spokesman for Glaxo's Biologicals unit in Brussels.
Drugmakers including London-based Glaxo and France's Sanofi- Aventis SA are developing products that may protect people in the event of a global flu outbreak. The spread of the H5N1 avian-flu strain has put humanity closer to another pandemic than at any time since 1968, when the last of the previous century's major outbreaks occurred, according to the World Health Organization.
``The purpose of this study is to assess the safety and efficacy of our candidate vaccine administered over a year'' and check that the immune response is the same among various production lots, Hacking said today in an e-mailed response to questions.
The study will help establish the vaccine's ability to protect against the H5N1 virus, which has killed 172 people in the past four years, most of them in Asia. Adult participants will receive a shot containing 3.75 micrograms of antigen plus a new additive to boost effectiveness, Hacking said.
Lack of production capacity globally means vaccine makers need to develop shots using the least possible amount of antigen, the toxic material that stimulates antibodies.
Glaxo won the first approval of a pandemic flu vaccine from the European regulators for its Daronrix mock-up product on Dec. 15. A recent study in Belgium of the company's second-generation vaccine found that two ``very low'' doses of antigen given 21 days apart and combined with the additive met regulators' goals in more than 80 percent of the people vaccinated, Glaxo said.
To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net
http://www.bloomberg.com/apps/news?pid=20601202&sid=a3eaKHGpTxvE&refer=healthcare
By Jason Gale
May 7 (Bloomberg) -- GlaxoSmithKline Plc, the world's second-largest drugmaker, will test its experimental bird flu vaccine on about 1,000 people in Singapore, Taiwan, Thailand and Hong Kong to gauge its effectiveness in Asians, an official said.
Recruitment for the study -- the final of three stages of clinical trials usually needed for a drug to be approved in the U.S. -- has started in Singapore, said Graeme Hacking, a spokesman for Glaxo's Biologicals unit in Brussels.
Drugmakers including London-based Glaxo and France's Sanofi- Aventis SA are developing products that may protect people in the event of a global flu outbreak. The spread of the H5N1 avian-flu strain has put humanity closer to another pandemic than at any time since 1968, when the last of the previous century's major outbreaks occurred, according to the World Health Organization.
``The purpose of this study is to assess the safety and efficacy of our candidate vaccine administered over a year'' and check that the immune response is the same among various production lots, Hacking said today in an e-mailed response to questions.
The study will help establish the vaccine's ability to protect against the H5N1 virus, which has killed 172 people in the past four years, most of them in Asia. Adult participants will receive a shot containing 3.75 micrograms of antigen plus a new additive to boost effectiveness, Hacking said.
Lack of production capacity globally means vaccine makers need to develop shots using the least possible amount of antigen, the toxic material that stimulates antibodies.
Glaxo won the first approval of a pandemic flu vaccine from the European regulators for its Daronrix mock-up product on Dec. 15. A recent study in Belgium of the company's second-generation vaccine found that two ``very low'' doses of antigen given 21 days apart and combined with the additive met regulators' goals in more than 80 percent of the people vaccinated, Glaxo said.
To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net