"We are pleased to partner with Merck on this important initiative, which has the potential to make an incredible impact on the lives of the infants in our country - and their families," said Margarita Gurdi?n, Minister of Health for Nicaragua. "We hope to initiate rotavirus vaccination and enhanced disease surveillance activities as part of our national infant immunization program later this year."
"With this program, the government of Nicaragua and Merck will make ROTATEQ available to every infant in Nicaragua in the very same year that the vaccine became available to children in the United States and in other developed nations," said Margaret G. McGlynn, president, Merck Vaccines. "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. We will also work with international public health and donor organizations to ensure that ROTATEQ is available and affordable for the world's poorest nations."
Rotavirus is a highly contagious disease typically characterized by frequent diarrhea, vomiting and fever that can lead to rapid dehydration in infants and young children. The public health challenge posed by rotavirus is enormous: worldwide, rotavirus has been estimated to cause more than 2 million hospitalizations and nearly 600,000 deaths each year among children under age five. In Latin America, rotavirus causes an estimated 75,000 hospitalizations annually. In Nicaragua, diarrhea and gastroenteritis are leading causes of death among children one to four years of age.
"This partnership between the Nicaraguan Ministry of Health and Merck is the type of cooperation between private organizations and national governments that can lead to great improvements for global public health. What we learn from this project can serve as a guide for other countries in Latin America and the Caribbean committed to the prevention of rotavirus. The more we know about successfully implementing a rotavirus vaccination program, the better chance we have of helping to protect children from this disease," said Sir George Alleyne, director emeritus of the Pan American Health Organization (PAHO).
In addition to helping protect infants and young children from a potentially serious disease, the Nicaraguan Ministry of Health and Merck will 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. These efforts are intended to enhance infrastructure to conduct rotavirus disease surveillance, assess the impact of vaccination programs and achieve sustainable capacity for vaccine program implementation.
"Merck is looking forward to working with the government of Nicaragua on this project. Nicaragua has a strong commitment to protecting the health and well-being of their country's children and has an admirable track record for implementation of nationwide immunization programs. We believe this program represents a significant opportunity to add to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries, and is an expression of Merck's commitment to improving access to important vaccines in the developing world," said Mark Feinberg, M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines.
The incidence of rotavirus infection is similar in both industrialized and developing countries, suggesting that a decrease in disease cannot be affected by improvements in hygiene or sanitation. While nearly every child in the world will have a rotavirus infection in early childhood, children in the poorest countries account for 82 percent of rotavirus deaths, due to higher malnutrition rates and limited access to intravenous rehydration.
Recent Rotavirus Outbreaks Have Had an Impact in Nicaragua
For the past several years, rotavirus outbreaks have had a dramatic impact in Nicaragua. According to PAHO, Nicaragua experienced an increase in reported cases of diarrhea in the beginning of 2005. That year there were a total of 64,088 cases and 56 deaths due to diarrhea as reported to the Nicaraguan Ministry of Health. Children less than five years of age were most affected, representing nearly three-quarters of all reported cases. Of the 56 deaths reported in the same time period, the overwhelming majority of the fatalities occurred in infants under two years of age. During this period of increased case reports, 253 children were evaluated for possible rotavirus infection and 59 percent of those children tested positive for rotavirus. Nicaragua has a population of 5.1 million, 13.5 percent of whom are under five years of age.
In recent years, Nicaragua has successfully controlled the spread of other vaccine-preventable diseases by achieving and maintaining high vaccination coverage levels and adding additional vaccines to their national infant immunization schedule, including the measles-mumps-rubella (MMR) vaccine in 1998. "Nicaragua continues to be globally recognized for its commitment to child health and effective health care programs. Through this partnership with Merck, Nicaragua will to be one of the first nations to use the rotavirus vaccine, which is another example of that commitment," added Gurdi?n.
Merck has filed for licensure of ROTATEQ in more than 100 countries and through its partnership with PATH, plans to conduct clinical trials of ROTATEQ in Africa and Asia.
ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks. The vaccination series consists of three ready-to-use liquid doses of ROTATEQ administered orally starting at six to 12 weeks of age, with subsequent doses administered at four to 10 week intervals. The third dose should not be given after 32 weeks of age.
ROTATEQ was approved by the United States Food and Drug Administration on February 3, 2006. The FDA approval of ROTATEQ was based on data from Merck's Phase III clinical trials of more than 70,000 infants, including data from the Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted. In these clinical trials, ROTATEQ prevented 98 percent of severe cases of rotavirus gastroenteritis and prevented 74 percent of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to placebo through the first full rotavirus season after vaccination. ROTATEQ also reduced hospitalizations by 96 percent and emergency room visits by 94 percent for rotavirus gastroenteritis caused by serotypes targeted by the vaccine through the first two years after the third dose.
Selected Important Information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. ROTATEQ helps protect against diarrhea and vomiting only if they are caused by rotavirus. It does not protect against diarrhea and vomiting that are caused by anything else. Also, it may not fully protect all children that get the vaccine and it does not help protect those children that already have the virus.
The efficacy of ROTATEQ beyond the second season after vaccination was not evaluated. The safety and efficacy of ROTATEQ have not been established in infants less than six weeks of age or greater than 32 weeks of age. No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including: those with certain disorders of the bone marrow or lymphatic system, those on immunosuppressive therapy or with an immunodeficient condition or those who have received blood products within six weeks of vaccination. In more than 11,000 infants in clinical trials, a Vaccination Report Card was used to report the presence of adverse events for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients. Adverse events that occurred at a statistically higher incidence within six weeks of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea, vomiting, otitis media (ear infection), nasopharyngitis (inflammation of the nasal passages and the pharynx) and bronchospasm.
About Nicaraguan Ministry of Health
The Nicaraguan Ministry of Health (Minsa) is the primary agency responsible for promoting, protecting, rehabilitating and improving the health of all citizens in the community. A comprehensive range of medical services, outreach programs, disease-related research and skilled staff are primary contributors that have delivered significant strides forward in improving the quality of life in Nicaragua. Through its public health stewardship, Minsa's efforts help to ensure that all residents have access, and the freedom to choose from a stable of high-quality health care services. For more information, visit www.minsa.gob.ni.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufacturers and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.
Merck, which operates as Merck Sharp & Dohme outside the United States, has had a presence in Latin America and the Caribbean since 1915, and today is proud to do business in nearly all of the region's 35 countries, from Mexico in the north to Chile in the south. Our activities in Latin America span from sales and marketing, to state-of-the art manufacturing and extensive clinical trials, employing several thousands of people throughout the region. Merck and its Latin American subsidiaries are dedicated to the communities and countries in which we operate, engaging in a variety of public-private partnerships aimed at improving health, education and the environment, among other initiatives.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
ROTATEQ? is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.