Government of Rwanda Introduces Merck’s ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent) to Help Protect Children Against Rotavirus


May 25, 2012 6:18 am ET

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

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

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

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

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.

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Please see Prescribing Information for RotaTeq®

and Patient Information for RotaTeq® at

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

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