Rotavirus Vaccine Program
Rotavirus infection is the leading cause of severe diarrhea and vomiting (gastroenteritis) in children under two and kills around 600,000 children each year, mostly in developing countries. With funding from the GAVI Alliance and the Vaccine Fund, the Program for Appropriate Technology in Health (PATH) established the Rotavirus Vaccine Program (RVP) in 2003. With its strategic partners, the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, RVP is working to accelerate introduction of the two available vaccines.
GlaxoSmithKline's vaccine, Rotarix™, is a two-dose oral vaccine targeting one rotavirus strain. GSK has completed trials in a number of developing countries, with more underway in conjunction with PATH in the course of 2006. GSK received approval from the Mexican regulatory authorities in July 2004 and launched the vaccine officially in Mexico in January 2005. Rotarix™ has now been approved in various countries in Europe, Latin America and Asia. By early 2006, four countries -- Brazil, Panama, Venezuela and El Salvador -- had decided to vaccinate all newborn babies. To date, GSK has distributed 1.4 million doses in Latin America, enough for 700,000 babies.
Merck & Co., Inc.'s vaccine, RotaTeq®, is a three-dose oral vaccine that protects against five common rotavirus strains. It has been tested in clinical trials in over 70,000 infants in 11 countries and Merck is working with RVP/PATH to conduct further trials in Africa and Asia. To date, Merck has filed for marketing authorization of RotaTeq® in more than 130 countries, and it is approved in over 80, including the USA, most European countries, Australia, Canada, Mexico and others.
In September 2006, Merck and the Nicaraguan Ministry of Health announced the RotaTeq® Partnership, to provide rotavirus vaccine to all Nicaraguan infants and to demonstrate the facility and public health impact of universal immunization with RotaTeq®. Through this partnership, all infants born in Nicaragua in a three-year period will receive free RotaTeq® vaccine.
The RotaTeq® launch in Nicaragua in October 2006 made it the first GAVI-eligible country to introduce rotavirus vaccine and was the first time that a vaccine was introduced in the public sector of a developing country in the same year as in the industrialized world. Historically, it has taken up to 15 years for new vaccines to reach the world's poorest countries. At the end of the project, Merck will sell RotaTeq® to the Nicaraguan government at prices significantly lower than those for the developed world. Merck is committed to make RotaTeq® available worldwide as quickly as possible, with no-profit prices for developing countries.