Pharmaceutical Business review

GSK wins European positive opinion for pneumococcal vaccine

The pediatric vaccine is proposed to be indicated for active immunization against invasive pneumococcal disease and middle ear infections caused by Streptococcus pneumoniae in infants and children from six weeks up to two years. The European marketing authorization for the vaccine is expected to be granted shortly.

GlaxoSmithKline’s (GSK) pneumococcal candidate vaccine is expected to deliver broad public health benefit by offering coverage against three additional pneumococcal strains (serotypes 1, 5 and 7F) on top of the seven serotypes (4, 6B, 9V, 14, 18C, 19F, 23F) which are covered in the existing pediatric pneumococcal vaccine. Serotypes 1, 5 and 7F are responsible for a significant burden of disease, accounting for 5-25% of all IPD cases.

Jean Stephenne, president and general manager of GSK Biologicals, said: This novel 10-valent pneumococcal vaccine is designed to provide broad protection against major disease causing strains of pneumococcus with the potential of a significant public health benefit in Europe as well as globally.

Once approved, this important pediatric vaccine, which fits easily into existing vaccination schedules, will provide doctors with a new option in preventing life threatening pneumococcal disease and middle ear infections.