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.
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.
ROTATEQ is an oral liquid vaccine requiring no reconstitution or mixing.
The safety and efficacy of ROTATEQ were established in Phase 3 studies of more than 71,000 infants from 11 countries and included the landmark Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted. Approximately 18 million doses of ROTATEQ have been distributed worldwide through September 2008. ROTATEQ has been approved in 87 countries around the world and is available in more than 50 countries.
Select Safety Information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised or to infants with a history of gastrointestinal disorders.
Caution is advised when considering whether to administer ROTATEQ to individuals with immunodeficient contacts.
More than 71,000 infants were evaluated in three Phase 3, placebo-controlled clinical trials. Serious adverse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported as a serious adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse events for ROTATEQ, compared to placebo, were bronchiolitis, gastroenteritis, pneumonia, fever, and urinary tract infection.
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ, as compared with placebo recipients, were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchospasm (1.1 percent vs. 0.7 percent).
In post-marketing experience, intussusception (including death) and Kawasaki Disease have been reported in temporal association with ROTATEQ.
ROTATEQ may not protect all vaccine recipients against rotavirus.
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