Government of Rwanda introduces Merck’s ROTATEQ® to help protect children against rotavirus

Merck (NYSE: MRK), known as MSD outside the United States and Canada, welcomes today’s launch in Rwanda of Africa’s first national rotavirus vaccination program with ROTATEQ® (rotavirus vaccine, live, oral, pentavalent), Merck’s vaccine for the prevention of rotavirus disease. Beginning today, the first infants will receive ROTATEQ at a health center in Musanze District, Northern Province, Rwanda. Following the initial launch, ROTATEQ will be routinely administered to all infants in Rwanda as part of its national vaccination program. During 2012, the Government of Rwanda Ministry of Health expects more than 100,000 children will receive the vaccine.

Worldwide, diarrheal infections caused by rotavirus are one of the biggest causes of childhood mortality. In Rwanda, diarrheal infections rank third among causes of death in children less than 5 years of age. Nearly 22 percent of all Rwandan children age 6 to 11 months and 25 percent of children age 12 to 23 months suffer from diarrheal infections. Samples tested from October 2010 to March 2012 showed that nearly half of the infections were caused by rotavirus.

“We congratulate the Government of Rwanda for the launch of this important public health initiative and applaud its efforts to help protect Rwanda’s children against rotavirus-associated diarrhea through a comprehensive initiative including vaccination and other public health efforts,” said Mark Feinberg, M.D., Ph.D., chief public health and science officer, Merck Vaccines. “Rwanda is committed to the vaccination of their children and their accomplishments to date have been impressive. Given the impact of rotavirus gastroenteritis in children, working to help reduce severe rotavirus disease represents a critically important public health goal and we’re pleased to be able to work with the GAVI Alliance to make ROTATEQ available to Rwanda and other GAVI-eligible countries worldwide.”

Rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children, is highly prevalent and highly contagious, infecting nearly all children worldwide by the age of 5, often more than once. In resource-limited countries, most children experience the first episode of rotavirus diarrhea before reaching age 1. Each year, rotavirus causes approximately 111 million episodes of gastroenteritis, 25 million outpatient visits, two million hospitalizations and more than 450,000 deaths in children younger than 5 years of age worldwide.

ROTATEQ® (rotavirus vaccine, live, oral, pentavalent) 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 6 to 32 weeks. The first dose of ROTATEQ should be administered between 6 and 12 weeks of age. ROTATEQ is an oral liquid vaccine requiring no reconstitution or mixing.

International organizations, such as the WHO, GAVI Alliance, the Gates Foundation and PATH, have recognized the importance of rotavirus vaccination. The Strategic Advisory Group of Experts, the principle advisory group to the WHO for vaccines and immunization, has recommended the inclusion of rotavirus vaccination in all national immunization programs since 2009 and GAVI Alliance and other stakeholders are working to make rotavirus vaccines available in the poorest countries of the world.

Other access efforts with ROTATEQ

With the introduction of ROTATEQ to Rwanda, Merck continues its tradition of making vaccines that address important medical needs available in resource-limited countries where the disease burden is high.

In 2006, Merck introduced ROTATEQ in Nicaragua through the Merck-Nicaraguan Ministry of Health ROTATEQ Partnership. This initiative marked the first time there was access to a vaccine in the public sector of a developing country in the same year it was first licensed in a developed country. This program completed in 2009 and achieved an estimated 92 percent vaccine coverage (percent receiving third dose of ROTATEQ) among Nicaraguan infants. In March 2010, the immunization program transitioned to GAVI funding.

Additionally, Merck has partnered with PATH and other organizations to better understand the safety and efficacy of ROTATEQ in Bangladesh, Ghana, Kenya, Mali and Vietnam. A clinical trial at these sites in Africa and Asia involved more than 7,500 infants and the data were published in August 2010 in the Lancet.

Since 2006, ROTATEQ® (rotavirus vaccine, live, oral, pentavalent) has been registered and approved in more than 100 countries with more than 71 million doses distributed worldwide. ROTATEQ targets the strains of rotavirus responsible for approximately 90 percent of rotavirus disease worldwide.

Information about ROTATEQ

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 3-dose series to infants between the ages of 6 to 32 weeks. The vaccination series consists of 3 ready-to-use liquid doses of ROTATEQ administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

Selected Safety Information about ROTATEQ

ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive ROTATEQ. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered ROTATEQ and later identified as having SCID.

Infants with a history of intussusception should not receive ROTATEQ.

No safety or efficacy data are available from clinical trials regarding the administration of ROTATEQ to infants who are potentially immunocompromised. No safety or efficacy data are available for administration of ROTATEQ to infants with a history of gastrointestinal disorders.

Vaccine virus transmission from vaccine recipient to non-vaccinated contacts has been reported. Caution is advised when considering whether to administer ROTATEQ to individuals with immunodeficient contacts.

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received ROTATEQ.

ROTATEQ may not protect all vaccine recipients against rotavirus.

Please see Prescribing Information for RotaTeq® at http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf and Patient Information for RotaTeq® at http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_ppi.pdf.

ROTATEQ® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.