The International Medica Foundation announced today that it has sublicensed to Shanghai BravoBio Co., Ltd. of China, the first rotavirus vaccine that has been clinically tested for use in newborns. This will be the first time that a rotavirus vaccine will be developed for the Chinese market where the first dose of the rotavirus vaccine will be orally administered to newborns. This agreement represents a major milestone in bringing a safer and superior rotavirus vaccine to families in need globally.
Rotavirus is a vaccine preventable disease but rotavirus gastroenteritis causes an estimated 329,000 hospitalizations and 4,900 deaths in infants and children each year in China. Almost 16 million babies are born in China annually and like all newborns the world over are at risk of rotavirus infection which can cause life-threatening diarrhea.
“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,” commented 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.”
International Medica has been developing a rotavirus vaccine for global use to overcome the shortcomings of the currently marketed rotavirus vaccines, which 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. International Medica’s oral rotavirus vaccine addresses all of these problems. Based on the RRV-TV vaccine originally developed at the National Institutions of Health, International Medica has successfully completed a large safety and efficacy Phase 2 clinical trial in Africa in 998 young infants that received both doses of the vaccine before they were 2 months old. “We are very pleased that our vaccine is providing strong, early protection to infants, usually before the first dose of other rotavirus vaccines is even administered. As recently reported in the Journal of Infectious Diseases, two early doses of our RRV-TV vaccine is comparable in efficacy to three doses of other rotavirus vaccines given later to older infants,” says Dr. Leonard Ruiz, President of International Medica.