WHO prequalifies GlaxoSmithKline's H1N1 pandemic vaccine

LONDON — GlaxoSmithKline announced Dec. 1 that the World Health Organization has awarded prequalification for global use of Arepanrix, its adjuvanted H1N1 pandemic vaccine manufactured in Canada.

This is the first prequalification for an H1N1 pandemic vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries. The WHO prequalification project is a service provided by the WHO to facilitate access to medicines that meet unified standards of quality and safety.

“The WHO has indicated that developing countries may be hardest hit by the H1N1 pandemic,” said Jean Stéphenne, president of GSK Biologicals. “It is clearly our collective responsibility to ensure that we do everything possible to provide vaccine supplies to these countries.”

Earlier this month 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.

Health Canada approved Arepanrix in October.

GSK was also awarded prequalification for its vaccine against pneumococcal disease in November, its cervical cancer vaccine in July and received an extended prequalification for a vaccine against rotavirus in June.