GSK Receives Prequalification From WHO For Synflorix

Published: 06-Nov-2009

Allows UN agencies to purchase vaccines on behalf of developing countries and accelerates global access to Synflorix

GlaxoSmithKline Biologicals (GSK) has received prequalification from the World Health Organization (WHO) for global use to Synflorix, pneumococcal conjugate vaccine.

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 industrialised country and just a few days after the First World Pneumonia Day, marked on 02 November.

GSK said that WHO has 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.

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

Jean Stephenne, CEO of GSK Biologicals, said: “GSK designed Synflorix to offer the right protection to children all over the world. 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."

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

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