WHITEHOUSE STATION, N.J., June 25, 2008 -
Merck & Co., Inc., maker of ROTATEQ® (rotavirus vaccine, live, oral, pentavalent), is pleased that the U.S. Centers for Disease Control and Prevention's (CDC) report shows that rotavirus disease was dramatically reduced in the U.S. from November 2007 through May 2008 compared to previous years. Further monitoring and investigation are needed to assess whether the observed reduction in rotavirus disease reported by the CDC is related to the use of ROTATEQ®.
Data from two different surveillance systems showed that in this ongoing rotavirus season, compared to previous years, there was a marked reduction in the number of positive laboratory tests for rotavirus gastroenteritis and associated medical care (hospitalizations, emergency room and clinic visits). ROTATEQ is currently the only rotavirus vaccine used widely in the U.S. The findings were published in this week's (June 26) edition of the CDC's Morbidity and Mortality Weekly Report.
"We are pleased to participate in the CDC's efforts to monitor the prevalence of rotavirus gastroenteritis and assess the impact of rotavirus vaccination," said Mary Allen Staat, M.D., M.P.H., professor of Pediatrics at the University of Cincinnati, and a member of the Infectious Disease Division at Cincinnati Children's Hospital Medical Center, one of the primary CDC rotavirus surveillance sites. "Although these data are preliminary, as a pediatrician I am excited about the marked reduction in rotavirus disease we saw this season which coincided with increasing uptake of ROTATEQ."
"The opportunity to make substantive contributions to advancing public health goals is what motivates us at Merck," said Mark Feinberg, M.D., Ph.D., vice president of medical affairs and policy, Merck Vaccines and Infectious Diseases. "We look forward to continuing to work with public health partners around the world to accelerate global access to ROTATEQ, and to ensure that it is used to its fullest potential to limit the significant global burden of rotavirus gastroenteritis."
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 55,000-70,000 hospitalizations, more than 200,000 emergency room visits, approximately 400,000 physician visits annually, and approximately 20-60 deaths per year among children under age 5. Rotavirus infection represents a significant burden in terms of resource use, with estimates of more than $1 billion (2006) in direct and indirect costs, including lost work time for parents, in the U.S. alone. Worldwide, nearly 600,000 children under age 5, approximately one child per minute, die from rotavirus every year, with 80 percent of deaths occurring in low-income countries.
In one analysis in the CDC report, the percentage of tests positive for rotavirus in the 2007-2008 rotavirus season was lower than in the previous 15 years. Only 18 percent of samples tested were positive during the peak of rotavirus season in April 2008 compared with a median of 41 percent (range 31-46 percent) for the previous seasons combined (July 1991 through June 2006). These results were based on data from the National Respiratory and Enteric Virus Surveillance System, a network of U.S. laboratories of which 70 were included in the 2007-2008 analysis.
In the second analysis in the CDC report, the data showed a marked reduction in hospitalizations and emergency room and clinic visits due to rotavirus gastroenteritis during 2008 compared with 2006 and 2007. Among those children who presented to hospitals, emergency rooms or outpatient clinics with acute gastroenteritis, 207 patients had rotavirus gastroenteritis in 2006, 259 in 2007, and only 18 in 2008. The overall proportion of fecal samples from these children that tested positive for rotavirus was approximately 51 percent in 2006, 54 percent in 2007 and only 6 percent in 2008. These results were based on data from the New Vaccine Surveillance Network, which conducts population-based surveillance for rotavirus gastroenteritis among children less than 3 years of age in three counties in the U.S.
ROTATEQ was approved by the U.S. Food and Drug Administration (FDA) in February 2006 for the prevention of rotavirus gastroenteritis in infants and young children, caused by serotypes G1, G2, G3, and G4 when administered as a three-dose series to infants between the ages of 6 to 32 weeks. More than 15 million doses of ROTATEQ have been distributed in the U.S. to date though the number of doses administered is not known. In the U.S., ROTATEQ is recommended by the CDC'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 six 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 the Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted, 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.
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 infants who have received 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.
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