GlaxoSmithKline (NYSE: GSK) has submitted regulatory approval to the European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C).
The conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity (in clinical trials including countries in Africa and Asia) against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C in addition to five other major childhood diseases.
According to Jean Stephenne, President of GlaxoSmithKline Biologicals:
"GSK's long-standing commitment to the developing world is reflected in the development of Globorix™, a vaccine designed specifically to meet a pressing public health threat in Africa.
Using the innovative Article 58 mechanism will expedite the availability of Globorix™ to those in greatest need while ensuring it meets the world's most stringent standards for safety and efficacy. This vaccine candidate could be available as early as 2008 and has the potential to break the cycle of meningitis epidemics in Africa.
It will provide babies with protection against 7 diseases in a combination vaccine and, administered in the classical Expanded Programme on Immunisation, it will help to simplify logistics and costs."
Globorix™ is intended for use in African meningitis belt countries, the Middle-East and Northern Africa, where it could replace the pentavalent combination vaccine (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b) already administered to many children.
Find more details from the press release.
[photo credit: vaccination liberation]
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