GlaxoSmithKline (GSK) has agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO). The company is collaborating with health authorities and expects to prepare the first shipments of vaccine for the WHO by the end of November.

The WHO will distribute the vaccine to developing countries that need it most. The organization has a list of 95 nations that are eligible to receive donated vaccines, and it plans to distribute enough vaccines to protect 10% of the population of these countries.

“GSK is committed to supporting governments and health authorities around the world in their efforts to protect their populations against this pandemic. Our commitment recognizes the needs of developing countries, and this donation of 50 million doses will enable vaccination to begin soon in some of the world’s poorest countries,” said Andrew Witty, GSK’s CEO, in a press statement.

“We welcome this very generous donation by GlaxoSmithKline, which will go to protect the health of the world’s poorest people,” said Margaret Chan, Director General of the WHO, in the press statement. “This is a real gesture of global solidarity toward those who would not be otherwise able to have access to the vaccine. WHO will now work to see that these vaccines are distributed to those who need them.”

GSK and the WHO also are discussing a possible donation of the company’s Relenza antiviral medicine to the organization. The company has established a tiered-pricing policy, based on the World Bank classification of countries, for Relenza. GSK is making Relenza Rotacaps and Diskhaler available at not-for-profit prices to the world’s 50 least-developed countries.

In related news, the US Food and Drug Administration approved a supplemental biologics license application (sBLA) for GSK’s unadjuvanted H1N1 pandemic vaccine last week. The company filed the sBLA as a strain-change supplement to its FluLaval seasonal flu vaccine.

The US Department of Health and Human Services ordered 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK. The company will produce the vaccine in multidose vials from bulk vaccine manufactured at its facility in Quebec (Canada). GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.

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