Globorix, GSK's Seven-in-One Vax

GlaxoSmithKline is seeking approval for a combination vaccine that covers an unprecedented number of bacteria and virus strains in the developing world--and could be cheaper and easier to administer to children.

Globorix covers two of the most common meningitis strains in Africa's sub-Saharan "meningitis belt," where epidemics commonly take thousands of lives each year, according to the World Health Organization. More than half of meningitis cases occur in children under age 5, and the disease can cause death within 24 to 48 hours. Globorix also provides immunity against diphtheria, tetanus, pertussis, hepatitis B, and a bacteria that can cause meningitis--five antigens that GSK already packages in a separate vaccine and distributes with the help of UNICEF.

Although GSK has not set a price for Globorix, Norman Begg, the company's director of medical affairs, expects that the product will have just a "small incremental cost increase" over the five-valent vaccine. "It doesn't require any additional infrastructure [to distribute Globorix] than already exists," he said. "That's particularly important in this resource-poor region."

GSK last week submitted its application to the European Medicines Agency under a provision known as Article 58, which allows European Union regulators to approve vaccines for the developing world. If accepted, Globorix could be available early next year. Sanofi-Aventis is also working on a meningitis vaccine for the developing world.

The approval of Globorix promises to revolutionize the vaccination strategy in the meningitis belt. While the current focus is on springing into action at the first signs of an epidemic, the conjugated technology used in the vaccine will allow public health officials to immunize infants before an outbreak hits. Globorix also provides longer-term protection and can be "refreshed" with boosters--a significant advance over older polysaccharide shots, which can be given only to older children and wear off within five years.

The conjugate technology will also be used to develop a pneumonia vaccine. "GlaxoSmithKline is committed to these combination vaccines," Begg said. "This represents another step forward in our combination vaccine strategy."