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Vaccine receives European authorisation

Wyeth Vaccines UK has been granted a European marketing authorisation for its pneumococcal conjugate vaccine, Prevenar 13

A European marketing authorisation has been granted by the European Commission to Wyeth Vaccines UK for its pneumococcal conjugate vaccine, Prevenar 13, for use in infants and young children.

Prevenar 13 is indicated for active immunisation for the prevention of invasive disease (including meningitis and septicaemia), pneumonia, and otitis media caused by the 13 pneumococcal serotypes included in the vaccine, in infants and young children from six weeks to five years of age.

It is based on the scientific foundation of Wyeth's 7-valent pneumococcal conjugate vaccine, Prevenar, which is used in more than 100 countries. Prevenar has been part of the UK's childhood immunisation schedule since September 2006.

Prevenar 13 will offer protection against 13 of the most common pneumococcal serotypes worldwide including serotype 19A, which has emerged as a serious public health threat in Europe and around the world. The new vaccine contains the seven serotypes in PCV-7 (4, 6B, 9V, 14, 18C, 19F and 23F) plus six additional serotypes (1, 3, 5, 6A, 7F and 19A), thereby extending the proportion of invasive pneumococcal disease preventable in the UK.

"Despite a significant reduction in pneumococcal disease covered by Prevenar since its introduction in 2006, disease caused by serotypes not covered by Prevenar is still a real problem in the UK," said Chris Head, chief executive, Meningitis Research Foundation. "The approval of Prevenar 13 is important news and we believe that access to a vaccine with the broadest available protection against pneumococcal disease is vital to improving the prevention of this devastating disease."

The marketing authorisation of Prevenar 13 was based on a clinical trial programme of 13 phase III studies involving more than 7,000 children.

14th December 2009

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