Children’s vaccine for pneumococcal meningitis receives approval
The European Commission has granted a European marketing authorisation for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]).
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 6 weeks to 5 years of age.
Prevenar 13 is based on the scientific foundation of Wyeth’s 7-valent pneumococcal conjugate vaccine, Prevenar (Pneumococcal polysaccharide conjugated vaccine, adsorbed [PCV-7]), which is the global standard as a result of its proven and established immunogenicity, efficacy and safety, being used in more than 100 countries with more than 300 million doses distributed. Prevenar has been part of the UK 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.
“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 marketing authorisation of Prevenar 13 was based on a clinical trial programme of 13 Phase III studies involving more than 7,000 children. These data indicate that Prevenar 13, has the potential to provide comprehensive protection against 13 of the most prevalent disease-causing serotypes covered in the vaccine. In addition, data indicate that Prevenar 13 has a safety and tolerability profile similar to that of PCV-7.
A UK study has demonstrated that Prevenar 13 is compatible with the UK immunisation schedule, an important consideration for the introduction of new vaccines to maintain the effectiveness of the existing immunisation schedule.