Prevenar 13 granted prequalification status

The World Health Organization has granted Pfizer Inc.'s Prevenar 13, a children's pneumococcal vaccine, prequalification status, which opens the door for United Nations agencies and governments to begin ordering the vaccine.

Prevenar 13 provides active immunization for infants and children between the ages of six week and five years of against against invasive disease, pneumonia and otitis media, which are caused by the 13 pneumococcal serotypes in the vaccine.

"We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organization's high standards for quality," Emilio Emini, chief scientific officer of vaccine research at Pfizer, said. "This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally."

Pfizer sent a 10 year provisional supply agreement in March 2010 to provide Prevenar 13 to infants and children in some of the world's poorest countries.

"Now that we have WHO prequalification for Prevenar 13, Pfizer will work with GAVI and UNICEF to finalize arrangements for first orders and shipments under the AMC," Mark Swindell, president of vaccines at Pfizer, said.

Pfizer, to meet growing global demand for Prevenar 13, will increase its manufacturing capabilities through a combination of capital investment, process improvements and efficiency measures.