GlaxoSmithKline Files Pneumococcal Paediatric Vaccine In The EU
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."
About bacterial respiratory infections
S. pneumoniaeand Haemophilus influenzae type b are well known causes of bacterial respiratory infections in young children. Disease caused specifically by Haemophilus influenzae type b is already addressed by existing conjugate vaccines. The "non-encapsulated" or "non-typeable" Haemophilus influenzae (NTHi) strains are also a leading cause of bacterial respiratory infections, yet currently are not vaccine preventable. S. pneumoniae and NTHi are recognized as the two leading causes of acute bacterial otitis media. Middle ear infections are a very common disease of childhood. In addition to the impact on the quality of life of many children and their families, middle ear infections also pose a significant medical and economic burden to healthcare systems 3,5.
About antibiotic resistance
Bacterial respiratory diseases are commonly treated with antibiotics. However, in some countries antibiotic resistance has been gradually increasing among S. pneumoniae and NTHi in recent years.8,9 This resistance makes treatment difficult and may result in longer hospitalisations and more expensive alternative therapy.10
GSK's pneumococcal haemophilus influenzae protein D conjugate candidate vaccine
Building on the platform of pneumococcal conjugate vaccination, this vaccine has been designed to confer dual protection against paediatric pneumococcal serotypes as well as potentially the second pathogen, NTHi, with a single vaccine. In the Pneumococcal Otitis Efficacy Trial (POET), an earlier prototype of the candidate vaccine provided evidence of dual protection against acute otitis media caused by both S. pneumoniae and NTHi.11 This approach is a continuation of the GSK heritage to develop combination vaccines which address several different pathogens at the same time with only one vaccine. Regulatory filings for this vaccine in additional countries have happened in parallel with the EU filing and will continue in 2008.
About GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals is one of the world's leading vaccine manufacturers. The company is located in Rixensart (Belgium) and is the centre of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK Biologicals employs over 5,000 people in Belgium (over 8,000 worldwide), of whom more than 1,500 are scientists passionately devoted to discovering innovative vaccines and developing cost-effective and convenient combination products that contribute to the health and well-being of billions of people, in every generation around the world.
In 2006, GSK Biologicals distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world an average of three million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines which protect the world's children against up to six diseases in one vaccine.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit http://www.gsk.com.
References
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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
6 Pichichero M E. Evolving Shifts in Otitis Media Pathogens: Relevance to a Managed Care Organization. Am J Manag Care 2005; 11:S192-S201
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 2006;367:740-748
GlaxoSmithKline fisiere Pneumococcal vaccin la copii în UE - GlaxoSmithKline Files Pneumococcal Paediatric Vaccine In The EU - articole medicale engleza - startsanatate