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WHO grants prequalification to Prevenar 13

The World Health Organization has granted prequalification to Prevenar 13, Pfizer's pneumococcal conjugate vaccine for infants

The World Health Organization (WHO) has granted prequalification to Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), Pfizer's pneumococcal conjugate vaccine (PCV) for infants.

Prequalification allows the vaccine to be procured by United Nations (UN) agencies, including member governments and the United Nations' Children's Fund (UNICEF), to be used in national immunisation programmes. Prevenar 13 is prequalified for global use of the vaccine in a single-dose vial.

The aims of prequalification are to make priority medicines available for those in need, with the WHO applying unified standards of acceptable quality, safety and efficacy to the process.

"We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organisation's high standards for quality," says Dr Emilio Emini, chief scientific officer, Vaccine Research, Pfizer. "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."

Prevenar 13, which is known in the US as Prevnar 13, includes the seven serotypes contained in Prevenar as well as an additional six. These serotypes represent the most prevalent invasive disease-causing serotypes in young children worldwide.

Pfizer had earlier this year entered into a 10-year agreement to provide Prevenar 13 to young children in developing nations under an Advance Market Commitment (AMC). This is a programme piloted by the Global Alliance for Vaccines and Immunisation's (GAVI) which requires WHO prequalification.

"WHO prequalification of Prevenar 13 is an important step towards universal access to pneumococcal conjugate vaccines for infants and young children worldwide," said Dr Orin Levine, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. "Under the AMC, pneumococcal conjugate vaccines can be made available to the highest risk children in the world faster than ever before."

24th August 2010

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