ROTATEQ® Receives WHO Pre-qualification

Significant Step in Merck’s Efforts to Expand Global Access to Rotavirus Vaccine

WHITEHOUSE STATION, N.J.- ROTATEQ® (rotavirus vaccine, live, oral, pentavalent), the pentavalent rotavirus vaccine from Merck & Co., Inc., that helps prevent rotavirus gastroenteritis in infants and children, has been awarded pre-qualification status by the World Health Organization (WHO). WHO pre-qualification allows for expanded access to ROTATEQ and provides a greater opportunity to help protect millions of babies from rotavirus gastroenteritis.

Because ROTATEQ is pre-qualified by the WHO, the vaccine is eligible for procurement by the Pan American Health Organization (PAHO), UNICEF and other United Nations agencies for use in national vaccination programs. Expanded access to ROTATEQ is especially important in the world’s least developed countries, where the consequences of rotavirus gastroenteritis can be very serious due in part to poorer access to healthcare and greater malnutrition. Rotavirus infects nearly all children worldwide by age 5 and causes approximately 1.9 million hospitalizations each year in developing countries. ROTATEQ is the only ready-to-use oral liquid rotavirus vaccine to receive WHO pre-qualification.

In the United States, ROTATEQ is indicated for use in infants and children for the prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 and is administered orally as a three-dose series between the ages of 6 and 32 weeks.

“WHO pre-qualification of ROTATEQ is an important milestone in expanding the global availability of ROTATEQ, and importantly, for facilitating efforts to accelerate the introduction of the vaccine in the world’s poorest countries,” said Mark Feinberg, M.D., Ph.D., vice president, Medical Affairs and Policy, Merck Vaccines and Infectious Diseases. “Merck’s pledge to provide ROTATEQ to GAVI-eligible countries at prices at which we do not profit is another step to make this vaccine accessible to all who need it in every part of the world.”

WHO pre-qualification of ROTATEQ is based on quality, safety and efficacy data generated in the U.S., Latin America and Europe. Merck has committed to provide additional safety and efficacy data from Africa and Asia and is currently conducting clinical trials in these regions in partnership with the Rotavirus Vaccine Program (RVP) of PATH, an international, non-profit organization.

“Vaccines are the best hope for preventing severe rotavirus gastroenteritis,” said John Wecker, Ph.D., director, PATH Rotavirus Vaccine Program. “WHO’s pre-qualification of ROTATEQ is a major step in ensuring that rotavirus vaccines are accessible to children worldwide.”

In late 2006, the GAVI Alliance, recognizing the public health need for rotavirus vaccines, committed to provide funding for the introduction of rotavirus vaccines in eligible countries. Public sector programs in European and Latin American countries that require WHO pre-qualification status may now select ROTATEQ for use in national rotavirus vaccination programs.

WHO pre-qualification is part of Merck’s systematic approach to the global introduction of ROTATEQ. In 2006, ROTATEQ was recommended for use in all children in the U.S. and in the same year, Merck created and implemented a first-of-its-kind donation and partnership program with the Nicaraguan Ministry of Health (MINSA), through which Merck introduced ROTATEQ in a GAVI-eligible country, Nicaragua. In the first two years of this ongoing three-year partnership, approximately 700,000 doses of ROTATEQ have been provided at no cost by Merck and the country has achieved rotavirus vaccination rates that are among the highest in the world.

About Rotavirus
Rotavirus is a leading cause of severe acute gastroenteritis in infants and young children. Rotavirus is highly prevalent and highly contagious, infecting nearly all children by age 5, many more than once, in both developed and developing countries. The virus causes more than two million hospitalizations and nearly 600,000 deaths worldwide among children under age 5 each year. Eighty percent of rotavirus-related deaths occur in developing countries. In the U.S., historically rotavirus has been responsible for an estimated 55,000 to 70,000 hospitalizations, more than 200,000 emergency room visits, approximately 400,000 doctor visits and approximately 20-60 deaths per year among children under age 5.