GSK Seeks Approval for New Meningitis Vaccine

A new conjugate meningococcal vaccine could be available in Africa's meningitis belt as soon as 2008, GlaxoSmithKline (GSK) has announced. The drugmaker submitted an application to the European Medicines Agency under a provision intended for approving medicinal products developed for use exclusively outside the European Union.

The combination vaccine candidate, Globorix, has been developed to protect infants against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and Neisseria meningitides serogroups A and C. In clinical trials in African countries, the vaccine has been shown to have a good safety profile.

In 2000 the World Health Organization called for the development of conjugate vaccines in order to shift the strategy for controlling meningitis away from expensive last-minute immunization drives toward more sustainable and long-term prevention campaigns.

Polysaccharide vaccines, which are used in reactive mass-immunization campaigns, do not protect infants, and in older children and adults they offer only three to five years of protection. They also do not address endemic meningitis, according to GSK.

Globori is intended for use in the Middle East and Northern Africa, where it could replace the pentavalent combination vaccine currently administered there. The new vaccine has been designed to fit with the Expanded Program on Immunization calendar of organized infant immunization campaigns in Africa.