Rotateq is Merck’s investigational vaccine to protect against rotavirus gastroenteritis. It is an oral, liquid vaccine that contains five human serotypes – G1, G2, G3, G4 and P1. These serotypes have been found to cause most rotavirus disease worldwide.
Merck also announced that it has plans to file for licensure of Rotateq in Australia, Canada, the EU and Mexico, as well as countries in Asia and Latin America in 2005.
Rotavirus causes approximately one-third of diarrhea-associated hospitalizations in developing countries and nearly half a million deaths worldwide every year in children under five. In the US, rotavirus accounts for approximately 50,000 hospitalizations, 500,000 visits to primary care offices and 20 to 40 deaths annually.
The FDA will determine whether it will accept Merck’s application for review within 60 days of the submission date.