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World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ Vaccine

Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day

Brussels, Belgium, 06 November 2009

The World Health Organization (WHO) has awarded prequalification for global use to Synflorix, GlaxoSmithKline Biologicals’ pneumococcal conjugate vaccine. The prequalification is the first for a vaccine against pneumococcal disease, which is a life-threatening disease affecting many children under five in developing countries. The WHO prequalification allows UN agencies to purchase vaccines on behalf of developing countries and will accelerate global access to Synflorix™.  The endorsement comes less than a year after the vaccine’s first licensure in an industrialized country and just a few days after the First World Pneumonia Day, marked on 02 November.

“GSK designed Synflorix™ to offer the right protection to children all over the world," said Jean Stéphenne, CEO of GSK Biologicals.  “The vaccine helps protect against 10 strains of pneumococcal disease and can make a lasting public health impact in developing countries, where the disease burden is greatest. GSK is especially proud to be the first company to receive prequalification for a pneumococcal vaccine that can save so many lives and dramatically alter the world’s fight against pneumonia." 

The WHO awarded prequalification for global use to a one-dose vial presentation of Synflorix™, which certifies the vaccine’s safety profile. GSK is working closely with the WHO to review a file for the prequalification of a two-dose vial, a presentation that could make more efficient use of limited refrigeration space in low-resource settings.

Among the 10 pneumococcal strains for which Synflorix™ offers protection, three – 1, 5 and 7F – are common in developing countries and are not currently prevented by the widely available pneumococcal vaccines. These strains must be addressed to significantly help reduce the global burden of pneumococcal disease, which results in nearly one million children fatalities in developing countries each year.

The rigorous WHO prequalification process began in early 2008, when GSK submitted for WHO prequalification within weeks of filing for approval from the European Medicines Agency (EMEA).  To receive WHO approval, new vaccines must demonstrate clinical impact in relevant settings and meet high international production standards.  Before approval is granted, the WHO conducts quality assurance tests on individual vaccine batches, thoroughly inspects manufacturing sites and consults closely with the relevant regulatory agency where the vaccine will be manufactured, in this case, the EMEA.

“Today’s WHO prequalification of Synflorix™ is an important step toward universal access to life-saving pneumococcal vaccines for children everywhere,” said Orin Levine, Executive Director of PneumoADIP at Johns Hopkins Bloomberg School of Public Health.  “Now, suppliers, international agencies, donors, and local governments must assure that these vaccines reach the children who need them most.”

GSK currently manufactures Synflorix™ at its plant in Belgium.  In June 2009, GSK opened a new $411 million plant in Singapore, which will have the capacity to meet the enormous need for pneumococcal vaccines in global markets in the coming years.

Today’s WHO endorsement of Synflorix™ continues GSK’s track record of seeking rapid WHO prequalification for its life-saving vaccines.  GSK was also awarded prequalification for Cervarix®, its cervical cancer vaccine, in July 2009 and received an extended prequalification for Rotarix™, another crucial vaccine against rotavirus, in June.  Together, these three endorsements will speed access to vaccines for major global health threats and save millions of lives over the coming years. 

About Synflorix™

GSK’s Synflorix™ is a complex 10-valent conjugate vaccine designed to protect children from invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae. The vaccine is expected to protect against an estimated 80 percent of invasive pneumococcal disease in children younger than five worldwide, including strains 1, 5 and 7F, which account for 3-23 percent of invasive pneumococcal diseases globally. The non-profit PneumoADIP estimates that widespread pneumo vaccination could save more than 5.4 million lives by 2030.

Synflorix™ also offers protection against middle ear infections (acute otitis media) caused by Streptococcus pneumonia, a common disease in infants and children that is a significant burden on healthcare infrastructure worldwide.

Synflorix™, a major technical achievement in vaccine science,is a complex conjugate vaccine that requires nearly 18 months to manufacture.  The complexity of Synflorix™ stems from the innovative conjugation process used to manufacture the vaccine. During the production process, the vaccine’s ten ‘valents’ – all of which help protect against a different strain of pneumococcal disease – are produced separately and then attached to individual ‘carriers’.  The main carrier is a protein derived from non-typeable Haemophilus influenzae (NTHi), another bacterium causing disease in children and adults.  In turn, these carriers help stimulate immune responses to the ten strains of pneumococcal disease that Synflorix protects against.

The clinical development program of Synflorix™ has spanned four continents, with more than 100,000 doses administered to date. Clinical trials have demonstrated the vaccine has an acceptable safety profile and immunogenicity level when vaccinating infants both pre- and full-term. Synflorix™ was approved by the European Medicines Agency in March 2009. The vaccine is currently approved in more than 40countries.

About GlaxoSmithKline Biologicals

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media.

GSK Biologicals is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. In 2008, GSK Bio distributed more than 1.1 billion doses of vaccines to 176 countries. Close to 80 percent of these doses were distributed in developing countries.

 

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