Synflorix™, GlaxoSmithKline’s pneumococcal vaccine, receives European authorisation

Protection now possible against three pneumococcal strains not covered by currently available vaccine

Issued:  Tuesday 31 March 2009, London UK

GlaxoSmithKline (GSK) today received European Commission authorisation for Synflorix™, a paediatric pneumococcal vaccine to protect against life-threatening diseases such as meningitis and bacteraemic pneumonia, as well as middle ear infections. In Europe, approximately one in three cases of serious pneumococcal disease in young children caused by bacterial serotypes is not covered by the currently available pneumococcal conjugate vaccine.[1]

Today’s decision opens access to a new vaccine that could potentially prevent childhood deaths and suffering, as well as deliver considerable public health benefits across Europe.  

GSK’s new vaccine is indicated for active immunisation against invasive disease and acute otitis media (AOM) caused by Streptococcus pneumoniae in infants and children from six weeks up to two years of age. Invasive pneumococcal diseases (IPD) caused by S. pneumoniae include meningitis, bacteraemia (blood infections), and bacteraemic pneumonia.[2]    

The vaccine has the potential to prevent more IPD than the currently available 7-valent vaccine, by offering coverage against three additional pneumococcal strains (serotypes 1, 5 and 7F).[3] The 10 serotypes included in the new vaccineare responsible for up to 90% of all cases of IPD in children younger than five years old in parts of Europe.[1,3,4] The three additional serotypes (1, 5 and 7F)3are highly invasive, increasingly prevalent (representing 5-25% of all IPD cases)[5] ,[6],[7].[8] and are directly associated with outbreaks and severe illness in young children.[9]

The new vaccine also provides protection against pneumococcal AOM.  Bacteria can be responsible for up to 70% of all clinical episodes of AOM, with S. pneumoniae and non-typeable Haemophilus influenzae (NTHi) the most common causes of bacterial AOM worldwide.2  It is estimated that three quarters of all children will experience at least one episode of AOM (viral or bacterial) before they reach three years of age, with more than a third experiencing recurrent infections.[10] On top of the burden to children and their parents, the condition also places a considerable strain on healthcare resources[11] – middle ear infections are the number one reason children under three years visit a physician10 and are responsible for one of the most common paediatric surgical procedures in Europe.[12] ,[13]   

“Childhood pneumococcal infections such as meningitis and pneumonia devastate families across Europe and throughout the world. The burden of these conditions – in terms of individual suffering, emotional impact and associated public health costs – is considerable”, comments Jean Stéphenne, President and General Manager, GSK Biologicals.  “By providing increased protection against three additional strains of bacteria associated with severe disease, Synflorix™ may help prevent more of these life-threatening infections than the currently licensed pneumococcal vaccine.  It also offers protection against middle ear infection caused by S. pneumoniae, a condition that affects many children and their families in Europe.” 

Notes to Editors

Synflorix™

The new 10-valent, pneumococcal conjugate vaccinehas an innovative design. It contains polysaccharides derived from 10 different strains of pneumococcal bacteria most of which are conjugated to protein D from NTHi. GSK’s clinical development programme for the vaccine includes trials in Europe, as well as Africa, Asia and Latin America.  As recommended by World Health Organization (WHO), the assessment of potential efficacy against IPD has been based on a comparison of immune responses to the seven serotypes shared between GSK’s vaccine and the currently licensed vaccine, plus additional serotypes 1, 5 and 7F. Importantly, the new vaccine’s immunogenicity2, safety and reactogenicity profile is comparable[14] to the currently licensed pneumococcal vaccine, and compatibility with major childhood vaccines has been demonstrated in co-administration studies.[15]   The recommended primary vaccination schedule is three doses, plus a booster.2 

GSK’s new vaccine uses novel technology and the same 10 serotypes contained in a prototype pneumococcal vaccine which, in a European trial, offered a 33.6% reduction of clinical AOM.[16]

European authorisation is a major milestone in the global licensing strategy of this vaccine.The licence is based on data from clinical trials in various countries across Europe (CzechRepublic, Denmark, Finland, France, Germany, Norway, Slovakia, Sweden and Spain), as well as Latin America (Chile). The vaccine is also approved in Canada for immunisation of infants and children (six weeks up totwo years) against 10 S. pneumoniae serotypes and invasive disease caused by these serotypes (received 11 December 2008) and, more recently in Australia (25 March 2009), for immunisation of infants and children (six weeks up to two years) against 10 S. pneumoniae serotypes in a broader range of infections caused by these serotypes, including invasive disease, pneumonia, and AOM.  Licensure is also in advanced stages of regulatory approval in many countries across the world.

In line with GSK’s commitment to providing access to vaccines for the developing world, the company submitted a file for this potentially life-saving vaccine to the WHO for prequalification (PQ) in early 2008. PQ is a WHO programme to facilitate access to medicines in less-affluent countries. The filing for WHO PQ happened in parallel with the very first filings for regulatory review (prior to licensure).

Pneumococcal disease

Pneumococcal bacteria can cause the life-threatening diseases meningitis, pneumonia and bacteraemia. These infections are collectively referred to as IPD and occur when pneumococcal bacteria infect normally sterile areas of the body.  S. pneumoniae can also cause less severe, but considerably more common non-invasive diseases of the respiratory tract including otitis media, sinusitis and bronchitis.[17]

Pneumococcal disease is a global health issue.  Each year, S. pneumoniae infectionsare estimated to kill one million children aged under five years of age worldwide.[18] There are more than 90 distinct pneumococcal serotypes, but only 10-15 cause the vast majority of invasive pneumococcal disease in young children.5

Middle ear infections

Otitis media is a common childhood disease with different aetiologies.2It is also one of the most frequent indications for the prescription of antibiotics in developed countries.[19]   Antibiotic resistance against the major causative pathogens, including S. pneumoniae, is increasing in many countries.[20] ,[21],[22]  Recurrent AOM often leads to surgical interventions. The insertion of grommets (also known as tympanostomy tubes) through the ear drum to allow aeration and drainage of the middle ear is one of the most common childhood surgical procedures in Europe.12,13

GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of three million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Synflorix is a trademark of the GlaxoSmithKline group of companies

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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

References

[1]      Pneumococcal Regional Serotype Distribution for Pneumococcal AMC TPP, PneumoADIP Report, November 2008. Available at:  www.vaccineamc.org/files/TTP_Codebook.pdf. Last accessed March 2009

[2]      Synflorix SPC 2009

[3]     Wysocki J, Galaj A , Omeñaca F et al. Immunogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenza protein D conjugate (PHiD-CV) in infants after 3-dose priming before 6 months of age. Data presented at ISPPD 2008

[4]     Zissis N et al. Serotype distribution and antimicrobial susceptibility of Streptococcus pneumoniae

        causing invasive infections and acute otitis media in children. Eur J Pediatr (2004) 163: 364-368

[5]      Hausdorff WP, Bryant J, Paradiso PR et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000; 30:100-21

[6]     BrueggemannAB, Spratt BG. Geographic distribution and clonal diversity of Streptococcus pneumoniae serotype 1 isolates. J Clin Microbiol 2003; 41: 4966–70

[7]      IhekweazuCA, Dance DA, Pebody R et al. Trends in incidence of pneumococcal disease before introduction of conjugate vaccine: South West England, 1996-2005. Epidemiol Infect 2007;26:1-7

[8]     Munoz-Almagro C et al. Emergence of Invasive Pneumococcal Disease Caused by Nonvaccine Serotypes in the Era of 7-Valent Conjugate Vaccine. Clin Infect Dis 2008; 46: 174–82.

[9]     Hausdorff WP. The roles of pneumococcal serotypes 1 and 5 in paediatric invasive disease. Vaccine; 2007; 25(13):2406-12.

[10]    Klein JO. Otitis media. Clin Infect Dis 1994; 19: 823-32

[11]    Stolk E, Mangen MJ, Wolleswinkel J et al.Healthcare use and societal burden due to childhood otitis media in 7 EU Countries. Data presented at ESPID May 2008

[12]    Haapkyla J, Karevold G, Kvaerner KJ et al.Finnish adenoidectomy and tympanostomy rates in children; national variation. International Journal of Pediatric Otorhinolaryngoloy 2006; 70: 1569-1573

[13]    Karevold G, Haapkyla J, Pitka et al. Paediatric otitis media surgery in Norway. Acta Oto-Laryngologica, 2007; 127: 29-33

[14]    Knuf M, Grunert D, Wysocki J et al. Safety and reactogenicity of the new 10-valent pneumococcal non-typeable Haemophilus influenza influenza protein D conjugate vaccine (PHiD-CV). Data presented at ISPPD 2008

[15]    Tejedor JC, Garcia-Sicilia J, Grunert D et al. Co-administration of the new 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with other routine paediatric vaccines. Data presented at ISPPD 2008

[16]     Prymula R, Peeters P, Chrobok V et al.Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typeable Haemophilus influenzae: a randomized double-blind efficacy study. Lancet 2006; 367:740-4

[17]   WHO Pneumoccocal Conjugate Vaccine for childhood immunization position paper, March 2007.  www.who.int/immunization/wer8212pneumococcus_child_Mar07_position_paper.pdf  Last accessed March 2009

[18]   World Health Organization. WHO fact sheet. Accessible at: www.who.int/vaccine_research/diseases/ari/en/index6.html Last accessed March 2009

[19]     Cripps AW, OtczykaDC, Kydb JM. Bacterial otitis media: a vaccine preventable disease? Vaccine 2005; 23:2304-2310

[20]    Pichichero ME. Evolving Shifts in Otitis Media Pathogens: Relevance to a Managed Care Organization. Am J Manag Care. 2005, 11:S192-S201

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

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

 

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