Merck's ROTATEQ® Reduced Hospitalizations And Emergency Department Visits Due To G9P1A[8] Rotavirus By 100 Percent

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 10 Dec 2007 - 0:00 PDT

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The prescribing information for Merck & Co., Inc.'s ROTATEQ® (rotavirus vaccine, live, oral pentavalent), the only vaccine in the U.S. to help prevent rotavirus gastroenteritis in infants and children caused by G1-G4 serotypes, now includes data showing that ROTATEQ reduced hospitalizations and emergency department visits caused by the G9P1A[8] rotavirus serotype, by 100 percent (zero cases were seen in those who received ROTATEQ compared with 14 cases in placebo recipients). These data are from a post-hoc analysis of healthcare utilization data from more than 68,000 infants in the Rotavirus Efficacy and Safety Trial (REST), one of the largest pre-licensure vaccine clinical trials ever conducted.

ROTATEQ is an oral vaccine and 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.

G1, G2, G3 and G4 are four common circulating serotypes of rotavirus, and have been responsible for approximately 90 percent of rotavirus disease in recent years in the U.S. The post-hoc analysis evaluated healthcare utilization data from rotavirus gastroenteritis caused by a fifth serotype, G9P1A[8].

Studies have shown that G9 strains (which include G9P1A[8] and G9P2[6]) appear to have changed in prevalence over time and are now considered to be one of the globally important strains. G9P1A[8] is also recognized as one of the common circulating serotypes of rotavirus historically in the U.S. "Because serotype distribution has been shown to vary between geographical settings and from one rotavirus season to another, it is important to help protect infants and children from many of the common circulating serotypes of rotavirus," said David Matson, M.D., Ph.D., Professor of Pediatrics and Director of the Graduate Program in Public Health at Eastern Virginia Medical School and Old Dominion University. "Merck's pentavalent rotavirus vaccine's prescribing information has now been updated to include post-hoc analysis data on another circulating rotavirus serotype of clinical and epidemiologic importance."

In REST, ROTATEQ demonstrated 98 percent efficacy against severe cases of rotavirus gastroenteritis and 74 percent of all rotavirus gastroenteritis cases caused by rotavirus serotypes G1, G2, G3 and G4 through the first rotavirus season post-vaccination (n=5673). Additionally, ROTATEQ reduced hospitalizations by 96 percent (n=68,038) and reduced emergency department visits by 94 percent (n=57,134) for rotavirus gastroenteritis caused by the G serotypes targeted by the vaccine (G1-G4), through 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. It is highly common and contagious, infecting nearly all children by the age of five, many more than once, in both developed and developing countries. 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).

Among children under five in the United States, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, with an estimated 205,000 - 272,000 emergency room visits and up to 70,000 hospitalizations.

Select safety and additional 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% vs. 42.8%). 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% vs. 21.3%), vomiting (15.2% vs. 13.6%), otitis media (14.5% vs. 13.0%), nasopharyngitis (6.9% vs. 5.8%), and bronchospasm (1.1% vs. 0.7%).

In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.

In the United States, 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. 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.

ROTATEQ was approved by the FDA on Feb. 3, 2006. Through Sept. 30, 2007, Merck has distributed more than nine million doses of ROTATEQ and ROTATEQ has been approved in 69 countries around the world.

ROTATEQ is a live, oral pentavalent vaccine that contains five live reassortant rotaviruses (G1, G2, G3, G4, and P1A[8]).

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.

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, 2006, 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.

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