The International Medica Foundation, a nonprofit foundation with the mission of providing safe and effective vaccines to the underserved populations of the world, has sublicenced to BravoVax Co., Ltd. of China the only rotavirus vaccine (RRV-TV) that has been successfully tested in a large phase 2 clinical trial to protect neonates from diarrhoea caused by rotavirus.

The study was completed in Africa in 998 newborns/young infants that received two doses of the RRV-TV vaccine before they were 60 days old. This study demonstrated that only two doses of RRV-TV could provide protection to very young infants well before other commercially available rotavirus vaccines. The RRV-TV vaccine provided protection against rotavirus gastroenteritis comparable in efficacy to three doses of the market leading rotavirus vaccine which is typically given later to older infants leaving them unprotected in their first months of life.

Rotavirus gastroenteritis is a vaccine preventable disease but it is still causing life-threatening diarrhoea leading to an estimated 400,000 deaths in infants and children each year in countries that are covered by this agreement. International Medica has licenced to BravoVax the worldwide rights (excluding the United States, Europe and Japan). This agreement represents a major milestone in bringing a safer and superior rotavirus vaccine to families in need globally.

The currently marketed rotavirus vaccines have a number of serious shortcomings: they do not protect very young infants since the first dose is usually administered at 2 months of age, they are associated with an increased risk of vaccine associated intussusception (a blockage of the intestine which requires hospitalisation) and they are costly and require expensive refrigerated distribution and storage, a major issue in many resource poor countries. International Medica’s oral rotavirus vaccine, RRV-TV, addresses all of these shortcomings.

“We are excited about our sublicence for the world’s first rotavirus vaccine for newborns that has superior attributes over the currently marketed rotavirus vaccines. Our plans are to be a global leader in providing a safe and cost effective vaccine against diarrhoea caused by rotavirus,” commented Dr. Wu Ke, managing director of BravoVax.

“We are very pleased that our RRV-TV vaccine, originally developed at the National Institutes of Health provided strong, early protection to infants, before the first dose of other rotavirus vaccines would typically be administered as reported in the Journal of Infectious Diseases. Since infant mortality due to rotavirus is high in the first months of life, the Foundation’s licencee, BravoVax, will be offering a vaccine that meets critical global needs,” said Dr. Leonard Ruiz, president of International Medica.

Dr. Wenyong Wang served as strategic advisor to the Foundation on the transaction.