MERCK LAUNCHES ROTAVIRUS VACCINE PROJECT IN NICARAGUA

Merck and the Nicaraguan Ministry of Health have announced plans to implement a rotavirus vaccination program in Nicaragua. Through the project, all infants born during a three-year period will receive free doses of Rotateq (rotavirus vaccine, live, pentavalent), the company's oral vaccine to prevent rotavirus gastroenteritis in infants ages 6 to 32 weeks when given in a three-dose series. Merck will also provide technical assistance for the program.

"We are launching this program to bring this important vaccine to children in one of the poorest nations of the world far sooner than has been the case for previous vaccines. At the end of the three-year project, we will make Rotateq available to the government of Nicaragua at prices dramatically lower than those in the developed world," said Margaret McGlynn, president of Merck Vaccines.

Rotavirus is a highly contagious disease characterized by frequent diarrhea, vomiting and fever that can lead to rapid dehydration in infants and young children. In Latin America, rotavirus causes an estimated 75,000 hospitalizations annually. In Nicaragua, diarrhea and gastroenteritis are leading causes of death among children 1 to 4 years of age.

The Nicaraguan Ministry of Health and Merck will also work with international public health organizations to strengthen the national rotavirus disease surveillance network, provide training and support for vaccine distribution and administration and create a model to assess the public health benefit resulting from the early adoption and use of a rotavirus vaccine.

Rotateq was approved by the FDA in February. The approval was based on data from Merck's Phase III clinical trials in more than 70,000 infants, including data from the Rotavirus Efficacy and Safety Trial, one of the largest pre-licensure vaccine clinical trials ever conducted.