GlaxoSmithKline (GSK) 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.
The 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.
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). The 10 serotypes included in the new vaccines are responsible for up to 90 per cent of all cases of IPD in children younger than five years old in parts of Europe. The three additional serotypes (1, 5 and 7F) are highly invasive, increasingly prevalent (representing 5-25 per cent of all IPD cases) and are directly associated with outbreaks and severe illness in young children.
The new vaccine also provides protection against pneumococcal AOM. Bacteria can be responsible for up to 70 per cent of all clinical episodes of AOM, with S. pneumoniae and non-typeable Haemophilus influenzae (NTHi) the most common causes of bacterial AOM worldwide. 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. On top of the burden to children and their parents, the condition also places a considerable strain on healthcare resources - middle ear infections are the number one reason children under three years visit a physician and are responsible for one of the most common paediatric surgical procedures in Europe.
"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."
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.