New Data Show Merck's Rotateq Helped Reduce Hospitalizations and Emergency Room Visits Due to Rotavirus Gastroenteritis for up to Three Years after Vaccination
WHITEHOUSE STATION, N.J., June 20, 2008 – Merck & Co., Inc. announced today that Rotateq (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine to help prevent rotavirus gastroenteritis (RGE), reduced the number of rotavirus gastroenteritis-associated hospitalizations and emergency room visits by 94 percent in healthy infants for up to three years after vaccination. These data from the Finnish Extension Study (FES), which extended the follow-up period of a subset of the Finnish participants (approximately 21,000 children) from the Rotavirus Efficacy and Safety Trial (REST), were presented today at the 13th International Congress on Infectious Diseases (ICID) in Kuala Lumpur, Malaysia. REST included over 70,000 infants and remains one of the largest pre-licensure vaccine clinical trials ever conducted.
As presented today, the data from the FES was combined with data from REST, for an overall 94 percent reduction of RGE-associated hospitalizations and emergency room visits by ROTATEQ compared to placebo, for up to three years post vaccination (33 cases in the vaccine group versus 546 in the placebo group, 95 percent CI [confidence interval]: 91, 96; n=57,054). In the first year post-vaccination, ROTATEQ reduced RGE-associated hospitalizations and emergency room visits, regardless of serotype, by 94 percent (27 cases in the vaccine group versus 447 in placebo group; 95 percent CI 91, 96; n=57,054). In the second year post-vaccination ROTATEQ reduced RGE-associated hospitalizations and emergency room visits, regardless of serotype, by 94 percent (6 cases in the vaccine group versus 98 in the placebo group; 95 percent CI 86, 98; n=17,041). In the third year post-vaccination, ROTATEQ reduced RGE-associated hospitalizations or emergency room visits, regardless of serotype, by
100 percent (one case in the placebo group while zero cases were reported in the vaccine group, 95 percent CI <0, 100; n=6099). The year three data alone were not statistically significant because only one case was reported.
"The data from FES when combined with REST, were consistent with the results from REST, and demonstrated an overall efficacy of ROTATEQ up to three years post-vaccination," said lead study investigator Timo Vesikari, M.D., of the University of Tampere, Finland. "The data demonstrated that vaccination with ROTATEQ helps protect children in the first years of life, the time when they are most susceptible to rotavirus disease." Dr. Vesikari conducted the FES to evaluate the efficacy of ROTATEQ, as measured by reduction in hospitalizations and emergency room visits, beyond the two years of follow-up in REST.
In REST, the majority of infants were followed for one year after their first dose of vaccine, and a subset was followed for up to a maximum of two years after the third dose. In the FES, infants continued to be followed for up to three years following the third dose to determine the protection provided by the vaccine against RGE-associated hospitalizations and emergency department visits. No safety data were collected during the FES.
ROTATEQ is an oral vaccine that helps prevent rotavirus gastroenteritis 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. In the U.S. ROTATEQ is recommended by the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP). In the U.S. the first dose of ROTATEQ should be administered between 6 and 12 weeks of age, with the subsequent doses administered at four to 10 week intervals. The third dose should not be given after 32 weeks of age.
In REST, ROTATEQ demonstrated 98 percent efficacy against severe cases of rotavirus gastroenteritis and 74 percent efficacy against all rotavirus gastroenteritis cases caused by serotypes G1, G2, G3 and G4 through the first rotavirus season post-vaccination (n=5,673). Additionally, ROTATEQ reduced hospitalizations by 96 percent (n=68,038) and reduced emergency room visits by 94 percent (n=57,134) caused by these same serotypes up to two years following the third dose. ROTATEQ may not protect all vaccine recipients against rotavirus.
Rotavirus is a leading cause of severe acute gastroenteritis in infants and young children worldwide, infecting nearly all children by the age of 5, many more than once. While many cases of rotavirus gastroenteritis are mild, some can be severe. In the U.S. it is estimated that rotavirus diarrhea is responsible for 55,000 to 70,000 hospitalizations, more than 200,000 emergency room visits, approximately 400,000 physician visits annually, and approximately20 to 60 deaths per year among children under age 5. Rotavirus infection represents a significant burden in terms of resource use, with estimates of more than one billion (2006) U.S. dollars in direct and indirect costs, including lost work time for parents, in the U.S. alone.
ROTATEQ was approved by the U.S. FDA on Feb. 3, 2006. Through May 2008, Merck has distributed more than 17 million doses of ROTATEQ worldwide. ROTATEQ has been approved in 85 countries around the world.
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.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures 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 www.merck.com.
Forward Looking Statement
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 risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
# # #
Prescribing information and patient product information for ROTATEQ® is attached and is also available at www.rotateq.com.
Media Contact:
Nalini Saligram
215-652-9232
