CDC Advisory Committee Unanimously Votes To Add Rotateq(R), New Rotavirus Vaccine, To The Childhood Immunization Schedule

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Immune System / Vaccines;  Pediatrics / Children's Health
Article Date: 23 Feb 2006 - 0:00 PDT

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Merck & Co., Inc. announced that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend that all infants, starting at six to 12 weeks of age, be vaccinated with ROTATEQ(R) (rotavirus vaccine, live, oral, pentavalent) to prevent rotavirus gastroenteritis, a leading cause of severe dehydrating diarrhea in infants and young children. The ACIP recommended that the oral, ready-to-use, three-dose vaccine be given during the current routine well baby visits at two, four, and six months of age. On February 3, the U.S. Food and Drug Administration (FDA) approved ROTATEQ, now the only vaccine available in the U.S. to prevent this serious and unpredictable disease, for use in infants between the ages of six to 32 weeks.

By the time children in the U.S. are five years old, approximately one out of every 17 will visit the emergency room, and one out of every 65 will be hospitalized for rotavirus gastroenteritis. "With about 2.7 million episodes of rotavirus occurring each year among children under age five in the U.S., this ACIP decision highlights the importance of rotavirus disease prevention and adds this needed vaccine to the current pediatric immunization schedule," said Mark Feinberg, M.D., Ph.D., vice president of Policy, Public Health and Medical Affairs, Merck Vaccines. "Merck is proud that its 15 years of research and development resulted in the availability of this vaccine. For the past several years we have been producing ROTATEQ and plan to meet the anticipated demand for the vaccine following this recommendation from the ACIP."

In addition to filing for licensure in more than 50 countries in 2005, Merck is working with PATH to conduct clinical studies of ROTATEQ in Africa and Asia. The trials are an important step in the process of making a rotavirus vaccine available in these regions.

Since 1964, the ACIP, a panel of 15 immunization experts, has provided recommendations to the CDC regarding vaccine use among the pediatric population. The ACIP now recommends vaccines for routine use in children to prevent diphtheria, Haemophilus influenza type b, hepatitis A, hepatitis B, influenza, measles, meningococcal disease, mumps, pertussis, pneumococcal disease, polio, rotavirus, rubella, tetanus and varicella. Merck makes vaccines to help protect against eight of these 15 diseases.

ROTATEQ Prevented Rotavirus Disease and Greatly Reduced Hospitalizations and Emergency Room (ER) Visits Caused by Rotavirus Gastroenteritis

Among infants observed in Phase III clinical trials, ROTATEQ prevented 98 percent of severe cases of rotavirus gastroenteritis and prevented 74 percent of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to placebo through the first full rotavirus season after vaccination. ROTATEQ reduced hospitalizations by 96 percent and ER visits by 94 percent for rotavirus gastroenteritis caused by serotypes targeted by the vaccine through the first two years after the third dose. As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients. The vaccine will also not help protect those children who already have the virus. ROTATEQ should not be used in infants that are allergic to any component of the vaccine.

In the large-scale Rotavirus Efficacy and Safety Trial, ROTATEQ did not increase the risk of intussusception compared to placebo. Within one year after the first dose, there were 13 cases of intussusception in the vaccine group and 15 in the placebo group. Among vaccine recipients, there were no confirmed cases of intussusception within the six week period after the first dose.

The most common adverse events reported after taking ROTATEQ in clinical trials were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection. The incidence of serious adverse events within six weeks of a dose of ROTATEQ was comparable among vaccine and placebo recipients. The most frequently reported serious adverse events were bronchiolitis, gastroenteritis, pneumonia, fever, and urinary tract infection.

Selected Important 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 six to 32 weeks. The vaccination series consists of three ready-to-use liquid doses of ROTATEQ administered orally starting at six to 12 weeks of age, with the subsequent doses administered at four to ten-week intervals. The third dose should not be given after 32 weeks of age.

The efficacy of ROTATEQ beyond the second season after vaccination was not evaluated. 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. No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including: those with certain disorders of the bone marrow or lymphatic system, those on immunosuppressive therapy or with an immunodeficient condition, or those who received blood products within six weeks of vaccination. In more than 11,000 infants in clinical trials, a Vaccination Report Card was used to report the presence of adverse events for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients. Adverse events that occurred at a statistically higher incidence within six weeks of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea, vomiting, otitis media (ear infection), nasopharyngitis (inflammation of the nasal passages and the pharynx) and bronchospasm.

Two Additional Merck Vaccines Under Review with FDA Merck has two other vaccines currently under review by the FDA. The FDA and other regulatory agencies around the world are reviewing applications for ZOSTAVAX(R), Merck's investigational vaccine to prevent shingles and shingles-associated pain in adults, and GARDASIL(R), Merck's investigational HPV and cervical cancer vaccine.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufacturers 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 http://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 cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

ROTATEQ(R) is a registered trademark of Merck & Co., Inc.

http://www.merck.com

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