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International Medica Foundation Starts Phase II Clinical Trial for Rotavirus Vaccine

International Medica Foundation Starts Phase II Clinical Trial for Rotavirus Vaccine

Lower-cost vaccine to prevent diarrhea to be tested in Africa

ROCHESTER, MINN. (Sept. 28, 2009) – 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.

This new clinical trial uses only two oral doses of the vaccine intended to be given very early in life, with the first dose being administered soon after birth and the second dose before the infant is 60 days old. Recent retrospective analysis has shown that when infants only received two doses of RotaShield in the United States, the vaccine appeared to be effective in preventing hospitalizations and emergency visits for all-cause acute gastroenteritis.

Neonatal dosing of RotaShield offers the promise of a number of advantages, including the potential that infants may be protected against rotavirus at an earlier age as rotavirus in developing countries strikes infants at a younger age than in industrialized countries. Neonatal dosing also minimizes the risk of intussusception associated with dosing at an older age. In addition, neonatal dosing would fit with the World Health Organization schedule that includes a BCG vaccine at birth and additional immunization visits at six, 10, and 14 weeks.

The International Medica Foundation plans that all 1,000 infants will be immunized prior to the beginning of this rotavirus season, which starts in early winter. The foundation believes that RotaShield, with its proven efficacy and – upon further examination – its safety, will be one of the quickest and the most cost-effective ways to prevent many of the deaths of children occurring daily in the developing world due to rotavirus.

About International Medica Foundation

The International Medica Foundation, which has all of the rights to RotaShield, is a nonprofit foundation that focuses on ensuring that a safe, effective and affordable rotavirus vaccine is clinically tested and then can be provided to families in need globally. The International Medica Foundation also aims to ensure that the manufacturing process for RotaShield is available to countries with the appropriate vaccine manufacturing capabilities.

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