Asian Scientist (Jul. 3, 2013) – The International Medica Foundation has sub-licensed RotaShield®, an oral rotavirus vaccine, to Shanghai BravoBio Co., Ltd. of China. RotaShield® is the first rotavirus vaccine that has been developed and clinically tested for use in newborns.
Gastroenteritis caused by rotavirus causes an estimated 329,000 hospitalizations and 4,900 deaths in infants and children each year in China.
Although there are rotavirus vaccines already available on the market, these do not protect very young infants, may be associated with an increased risk of vaccine associated intussusception (a blockage of the intestine which requires hospitalization), are costly and require expensive refrigerated storage.
RotaShield® addresses all of these problems and the vaccine has successfully been tested for safety and efficacy in a large phase 2 clinical trial in Africa. The clinical trial involved 998 young infants who received the two required doses of the vaccine before they were 2 months old.
“We are excited about our sublicense for the world’s first rotavirus vaccine for newborns and that it has superior attributes over the currently marketed rotavirus vaccines,” said Dr. Wu Ke, President of BravoBio.
“Once we obtain regulatory approval, China will lead the world in providing early protection against diarrhea caused by rotavirus in young infants.”
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Source: International Medica Foundation.
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