World Health Organization certifies GSK's H1N1 vaccine

Posted December 1, 2009 8:42 a.m. EST

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— GlaxoSmithKline (NYSE: GSK) says one of its swine flu vaccines has been certified by the World Health Organization, making it available for use in developing countries.

In a statement issued Tuesday, GSK said WHO had approved its Canadian vaccine after examining its quality and safety data. The vaccine contains an adjuvant, a chemical compound to boost the immune system.

"As H1N1 continues to spread it is critical that all people around the world have access to an effective H1N1 vaccine during the pandemic,” said Jean Stephenne, president of GSK Biologicals. “Since the start of the H1N1 pandemic GSK has been diligently working to achieve this and the WHO prequalification is a key step in ensuring that developing countries can be supplied with Arepanrix.

“The WHO has indicated that developing countries may be hardest hit by the H1N1 pandemic,” she added. “It is clearly our collective responsibility to ensure that we do everything possible to provide vaccine supplies to these countries.”

In November, GSK announced that it has signed an agreement with the WHO to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to the WHO for the distribution to developing countries most in need.

Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured H1N1 vaccine in case it triggered life-threatening side effects like anaphylactic shock.

Several vaccine makers have promised WHO 156 million doses of swine flu vaccine, which it hopes to start shipping to 95 poor countries this month.