European regulators have issued a green light for UK drug giant GlaxoSmithKline’s pneumococcal vaccine Synflorix, which has been designed to protect children against life-threatening diseases such as meningitis and bacteraemic pneumonia.

Specifically, the European Commission has approved the new vaccine 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.

Synflorix is a 10-valent vaccine that has been developed with novel technology using a carrier protein to induce protection against both invasive pneumococcal disease and bacterial respiratory infections, according to the company.

GSK claims its product offers an advantage over current paediatric vaccination because it protects against S. pneumoniae as well as non-typeable Haemophilus influenzae (NTHi), which, it says, is currently not yet vaccine preventable.

Both S. Pneumoniae and NTHi are leading causes of bacterial respiratory infections such as otis media, an acute infection of the middle ear, which is one of the most frequent childhood diseases and accounts for the most visits to the doctor in children under the age of three.

Moreover, GSK’s vaccine is active against a wider range of S. Pneumoniae serotypes, offering coverage against three additional pneumococcal strains (serotypes 1, 5 and 7F) than current vaccination. In fact, the 10 serotypes in the new vaccine cause up to 90% of all cases of IPD in children less than five years old in parts of Europe, the group says, which could give the vaccine an important competitive edge.

Touting the potential advantages, Jean Stéphenne, President and General Manager of GSK Biologicals, said: “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.”

Competition for Prevnar
Synflorix will now compete with Wyeth’s 7-valent pneumococcal conjugate vaccine, Prevenar, which has been part of the UK childhood immunisation schedule since September 2006 and, according to the firm, “is the global standard in pneumococcal disease prevention in infants and young children as a result of its established immunogenicity and efficacy”.

In response to news of Synflorix’ approval, Wyeth stressed that Prevenar’s efficacy and its compatibility with the other childhood vaccines in the UK “has been established both in clinical trials and through real life experience since its introduction in 2006”.

And Dr Vignesh Rajah, Wyeth’s Medical Director, said policy makers in the UK need to “pay close attention to all the available evidence when considering the introduction of any new vaccine,” including its safety record, efficacy, immunogencity and compatibility with the current childhood immunisation schedule in the UK.