FDAnews
www.fdanews.com/articles/88534-south-africa-obtains-gsk-rotavirus-vaccine

SOUTH AFRICA OBTAINS GSK ROTAVIRUS VACCINE

July 20, 2006

The South African Medicines Control Council (MCC) has registered an oral rotavirus vaccine produced by GlaxoSmithKline (GSK). The vaccine's registration was fast-tracked by the MCC, following an appeal by the company to the health minister.

Earlier in the year, the U.S. Advisory Committee on Immunization Practices recommended that all babies be vaccinated against rotavirus. A recent study at King Edward V Hospital in Durban found that almost a quarter of babies who had died from diarrhea were infected by the rotavirus.

According to the company, over 70,000 babies were involved in the development of the vaccine, and studies were conducted in Europe, the U.S., Africa, Latin America and Asia to evaluate the safety and efficacy of the vaccine.