More than half a million children – or 1,400 to 1,600 each day – die from rotavirus, the most common cause of severe childhood diarrhea. Almost all of these deaths occur in developing countries, where lifesaving medical care may not be affordable or available to the families with the most critical needs. In addition, income loss due to the need for parents to take care of sick children can have a very significant economic burden on families that can least afford it. To combat rotavirus, the International Medica Foundation is sponsoring a Phase II clinical trial of its oral rotavirus vaccine, RotaShield®. The trial is being conducted in more than 1,000 infants in Ghana, Africa, in association with the Noguchi Memorial Institute for Medical Research.
“The current rotavirus vaccines on the market are used in the United States and internationally by those who can afford them, or in a few countries through subsidies or government support, but economic issues prevent the majority of the families in need in developing countries from access to a cost-effective rotavirus vaccine,” said Dr. Leonard Ruiz, President of the International Medica Foundation. “Our approach will not only cost less, but our strategy is to make this an economically sustainable vaccine by ultimately providing the manufacturing know-how and assistance to developing countries with the infrastructure to produce vaccines. Even with discounting or subsidies by healthcare-related organizations, I believe that affordability of the two existing rotavirus vaccines is not economically sustainable long-term in developing countries.”
RotaShield originally was created by National Institute of Health scientists led by Albert Z. Kapikian, M.D., and was further developed by Wyeth. The U.S. Food and Drug Administration (FDA) licensed RotaShield in 1998 to be administered in three oral doses at two, four and six months of age. When the vaccine was administered to older infants outside of the approved FDA dosage schedule there was an association with an intestinal blockage called intussusception in some older infants. As a result, the manufacturer voluntarily withdrew RotaShield from the market in 1999. The FDA’s more recent approval of the two latest rotavirus vaccines have required well-defined age limits in the infants being administered those oral rotavirus vaccines.