The genesis for the formation of the International Medica Foundation and its top priority is to continue the work done by the National Institutes of Health (NIH) to bring an oral rotavirus vaccine to infants in the developing countries where rotavirus causes 600,000 deaths annually.
Globally, infections from the rotavirus account for an estimated 125 million cases of diarrhea each year, resulting in the deaths of approximately 600,000 infants annually from a disease that is highly preventable with an oral vaccine. Worldwide, rotavirus infects every child in the world in their first few years of life and sends 1 child in every 5 to 8 to a clinic for treatment, 1 in every 58 to a hospital, and 1 in 250-300 die from dehydrating diarrhea. Rotavirus is the cause of 30% to 40% of the hospitalizations for diarrhea in children less than five years of age and results in over 1,600 deaths each day in developing countries where medical care is limited and malnutrition is prevalent.
The rotavirus vaccine, known as RotaShield, was invented and initially developed by the National Institutes of Health of the United States (“NIH”). Ultimately, Wyeth Pharmaceuticals, Inc. in cooperation with the NIH, brought RotaShield through the laborious FDA regulatory path and introduced RotaShield into the U.S. market. After concerns of incidences of a condition called intussusception, Wyeth abandoned the RotaShield vaccine. Our Foundation ultimately gained the rights to this vaccine through the NIH.
Over the years following the withdrawal of RotaShield, a considerable number of scientific publications and presentations have revaluated and revisited various aspects of the causal association between vaccination and intussusception. The most current evidence indicates a strong age-related effect on the association between any rotavirus vaccine use and the initial association with intussusception, i.e. the vaccine was administered to infants in an older age group that should not have received the vaccine. The incidence of intussusception increases in infants as they age, peaking between 6 and 9 months of age. When RotaShield was first approved and administered to infants in the US, a majority of the first dose of the vaccine was given to infants in this older age group. Today, based on scientific publications that have reported the detailed analysis of data on 433,222 infants that received RotaShield, when the first dose had been given to some of these infants when they were less than 60 days of age, there was no association with intussusception.
In 2008 and continuing currently, our personnel have been working extensively along side with the NIH and IDT Biologika, a vaccine manufacturer, to complete a finalized vaccine product for use in clinical trials. A completed vaccine for use in clinical trials should be available by the end of March 2009.