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news.The World Health Organization (WHO) has awarded prequalification for global use of Synflorix, GlaxoSmithKline Biologicals’(GSK) pneumococcal conjugate vaccine. This endorsement allows UN agencies to purchase vaccines on behalf of developing countries.
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The endorsement comes less than a year after the vaccine’s first licensure and will accelerate global access to Synflorix.
Jean Stephenne, CEO of GSK, said: “The vaccine helps protect against 10 strains of the pneumococcal bacterium and can make a lasting public health impact in developing countries, where the disease burden is greatest.”
GSK is working closely with the WHO to review a file for the prequalification of a two-dose vial.
The WHO prequalification process began in early 2008, when GSK submitted for this prequalification within weeks of filing for approval from the European Medicines Agency (EMEA).
Before approval is granted, the WHO conducts quality assurance tests on individual vaccine batches, inspects manufacturing sites and consults closely with the relevant regulatory agency, the EMEA.
GSK currently manufactures Synflorix at its plant in Belgium.