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GlaxoSmithKline files pneumococcal paediatric vaccine in the EU


Breakthrough vaccine design targeting two bacterial pathogens

SynflorixTM (Pneumococcal Haemophilus influenzae Protein D conjugate vaccine) has beenaccepted for review by the European Medicines Agency (EMEA), GlaxoSmithKline (GSK) announced today. The 10-valent vaccine is designed to protect children against both invasive pneumococcal disease (IPD) and bacterial respiratory infections such as acute middle ear infections (otitis media). GSK utilizes a breakthrough approach in pneumococcal vaccine technology with this candidate vaccine. It has been designed with an active carrier protein to induce protection against non-typeable Haemophilus influenzae (NTHi) in addition to Streptococcus pneumoniae.

IPD are infections caused by the S. pneumoniae bacterium, of which the most common diseases are meningitis, invasive pneumonia, and bacteraemia. The vaccine offers the potential for expanded protection against S. pneumoniae serotypes beyond those covered by the current paediatric vaccination, including three serotypes (1, 5, 7F) associated with severe pneumococcal disease in children younger than 5 years of age.1,2 The 10 S. pneumoniae serotypes in the candidate vaccine account for over 80% of paediatric invasive pneumococcal disease worldwide.1,2 Most of the S. pneumoniae serotypes contained in the vaccine are conjugated to the immunologically active protein D derived from non-typeable Haemophilus influenzae to induce protection against NTHi in addition to S. pneumoniae.

The burden of otitis media worldwide is significant: it is one of the most frequent childhood diseases, the most common reason for physician visits in children under 3 years of age and the most frequent indication for prescription of antibiotics.3 The pathogens, S. pneumoniaeand NTHi, are recognized as the two leading causes of acute bacterial otitis media, each accounting for up to 40% of cases in children, yet NTHi is currently not vaccine preventable. 3,4,5,6,7

Jean Stéphenne, President of GlaxoSmithKline Biologicals, said “We are very pleased with this important step towards the introduction of this vaccine, which is designed to offer a broad protection against pneumococcal disease and a dual pathogen protection against otitis media caused by Strep pneumoniae and non-typeable Haemophilus influenzae. This approach is a continuation of our heritage to develop vaccines which address multiple pathogens with a single vaccine. If approved, this vaccine could further reduce the mortality due to invasive pneumococcal disease and also the significant morbidity associated with a more frequent disease in children, namely otitis media.”

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2 Hausdorff WP, Feikin DR, and Klugman KP. Epidemiological differences among pneumococcal serotypes. Lancet 2005; 5:83-93 [Review]

3 Cripps AW, Otczyka DC, Kydb JM. Bacterial otits media: a vaccine preventable disease? Vaccine 2005 23:2304-2310

4 Murphy TF. Respiratory infections caused by non-typeable Haemophilus influenzae. Curr Opin Infect Dis 2003; 16:129-134

5 Klein JO. Otitis media. Clin Infect Dis 1994; 19:823-32

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7 Block S L., Hedrick J, Harrison CJ, et al. Community Wide Vaccination with the heptavalent Pneumococcal Conjugate Significantly Alters the Microbiology of Acute Otitis Media. Pediatr Infect Dis J 2004;23:829-833

8 Leibovitz E. Acute otitis media in paediatric medicine. Current issue in epidemiology, diagnosis and management. Pediatr Drugs 2003;5 (Suppl 1):1-12

9 Cartwright K. Pneumococcal disease in Western Europe: burden of disease, antibiotic resistance and management. Eur J Pediatr 2002; 161:188-195

10 File T et al. Guidelines for Empiric antimicrobial prescribing in community-acquired pneumonia. Chest 2004;125:1888-1901

11 Prymula R, Peeters P, Chrobok V. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by streptococcus pneumonaie and non-typable haemophilus influenzae: a randomised double-blind efficacy study. Lancet
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