GSK’s pneumococcal vaccine receives European authorization

New vaccine offering broader coverage available soon in the Philippines

GlaxoSmithKline (GSK) today announced that it has received European Commission authorization for its pediatric pneumococcal vaccine to protect against life-threatening diseases such as meningitis, bacteremia (blood infections), bacteremic pneumonia, as well as middle ear infections.

This development will make available a new vaccine that offers additional protection against pneumococcal strains not covered by the currently available vaccine. According to the World Health Organization, at least one child dies of pneumococcal disease every minute, making it the leading cause of childhood deaths in the developing world and the number one vaccine-preventable cause of death in children worldwide.

“We’re very happy to learn about the approval from the European commission as it will help pave the way for GSK to bring the new pneumococcal vaccine to countries like the Philippines where it is needed the most,” said GSK Philippines Medical Director for Biologicals Dr. Sally Gatchalian. “Pneumonia is still one of the leading causes of death in the country so the vaccine’s broader protection could potentially prevent more childhood deaths and suffering not only in the Philippines but worldwide.”

European authorization is a major milestone in the global licensure of this vaccine, which has also been approved in Canada and Australia. The registration approval from the Philippines’ Bureau of Food and Drugs is also expected in the coming months.

GSK’s vaccine is indicated for active immunization against invasive pneumococcal disease (IPD) and acute otitis media (AOM) caused by Streptococcus pneumoniae in infants and children from six weeks up to two years of age.

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. These serotypes are highly invasive and increasingly prevalent (responsible for 5-25% of all IPD cases). In the Philippines, studies have shown that serotypes 1, 5, and 7F have caused up to 22% of IPD cases. Globally, the 10 serotypes included in GSK’s candidate vaccine are responsible for up to 90 % of invasive IPD in young children.

In addition to broader coverage against IPD, GSK’s vaccine is also designed to provide significant protection against the common middle ear infection known as AOM. It is estimated that three quarters of all children will experience at least one episode of AOM before they reach three years of age, with more than a third experiencing repeated infections that may lead to hearing disorders and learning disabilities in children. The condition therefore places a high burden on children and their families, as well as a strain on healthcare resources.

“Childhood pneumococcal infections such as meningitis and pneumonia devastate families throughout the world. These conditions bring considerable burden in terms of individual suffering, emotional impact and financial costs”, comments Jean Stéphenne, President and General Manager, GSK Biologicals. “By providing broader protection against IPD and AOM, including coverage against three additional pneumococcal strains associated with severe disease, GSK’s vaccine may help prevent more of these life-threatening infections.”

As one of the world’s leading vaccines manufacturer, GSK is committed to improving the quality of human life by enabling people to do more, feel better and live longer.