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|  |  FDA Approves Vaccine to Help Protect Children Against Measles, Mumps, Rubella and Chickenpox in One ShotPress Release September 7, 2005 PROQUAD(R) Combines Two Well-Established Merck Vaccines, M-M-R(R)II and VARIVAX(R) WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Sept. 6, 2005--Merck & Co., Inc. today announced that the U.S . Food and Drug Administration has approved the Company's combination vaccine PROQUAD(R) (Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live) for simultaneous vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age. PROQUAD is the first and only vaccine approved in the United States to help protect against these four diseases in a single shot. PROQUAD is also approved for use in children 12 months to 12 years of age if a second dose of measles, mumps, and rubella vaccine is to be administered. PROQUAD, which reflects more than 20 years of Merck research, combines two well-established Merck vaccines - M-M-R(R)II (Measles, Mumps and Rubella Virus Vaccine Live) and VARIVAX(R) (Varicella Virus Vaccine Live (Oka/Merck)). Vaccination with M-M-R II has contributed to a greater than 99 percent reduction in the United States in the incidence of measles, mumps and rubella -- diseases that have been associated with serious complications and once claimed tens of thousands of lives each year in this country alone. Since its licensure in 1995, VARIVAX has contributed to a significant reduction in the number of chickenpox cases in the United States. Chickenpox-related hospitalizations and deaths have also declined over the past decade in the United States. PROQUAD builds on the tradition of these Merck vaccines in helping to protect children against these four potentially serious diseases. "Until now, a young child had to undergo two separate vaccinations against these diseases. The approval of PROQUAD makes it more likely that more children can gain protection against these four diseases because fewer shots can potentially mean better compliance," said Henry Shinefield, M.D., clinical professor of pediatrics and dermatology, University of California School of Medicine at San Francisco, clinical investigator for PROQUAD and author of more than 150 published articles related to vaccination. "By allowing vaccination against chickenpox to occur simultaneously with vaccination against measles, mumps and rubella, PROQUAD can help increase the number of children vaccinated against chickenpox at the earliest recommended time -- upon a baby's first birthday." Preference for Combination Vaccines Leading U.S. authorities on vaccination -- such as the American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP) and the Center for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) -- recommend routine vaccination against measles, mumps, rubella and varicella. As a combination vaccine indicated for simultaneous vaccination against all four of these diseases in children 12 months to 12 years of age, PROQUAD can help physicians meet these vaccination recommendations. Moreover, according to the report "Combination Vaccines for Childhood Immunization," issued by the ACIP in 1999, "the use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines." Potential advantages of combination vaccines include reducing multiple injections, improving timely vaccination coverage, reducing the costs of stocking and administration of separate vaccines for health care providers and reducing health care costs for extra health visits, according to the report. "Based on the public health benefits realized following the introduction of other combination vaccines, such as M-M-R II, we expect PROQUAD to become a primary option for prevention of measles, mumps, rubella and chickenpox," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccine Division. "PROQUAD can help reduce the gap that exists in the United States between vaccination rates for chickenpox -- which were an estimated 87.5 percent in 2004 -- and rates for measles, mumps and rubella -- which were an estimated 93 percent in 2004. The main goal for any vaccine is to help eliminate disease and this is possible when very high vaccination rates are achieved in the community." PROQUAD Provided Immunogenicity Similar to its Component Vaccines Merck's Biologics License Application for PROQUAD included results from studies that evaluated the immunogenicity, antibody persistence and safety of PROQUAD compared to its component vaccines. Immunogenicity was studied in 5,835 healthy children 12 months to six years of age with a negative clinical history of measles, mumps, rubella and varicella who participated in five randomized trials. In these trials, the immunogenicity of PROQUAD was similar to that of its individual component vaccines, M-M-R II and VARIVAX. In four randomized trials in which 5,446 healthy children aged 12 to 23 months received PROQUAD, vaccine response rates for PROQUAD were similar to the rates induced by the concomitant administration of single doses of M-M-R II and VARIVAX at separate injection sites in 2,038 children. Results showed that following a single dose of PROQUAD, the immune response rates were 97.4 percent for measles, 95.8 to 98.8 percent for mumps, 98.5 percent for rubella and 91.2 percent for chickenpox. The duration of protection from measles, mumps, rubella and chickenpox infections after vaccination with PROQUAD is unknown. In two of the four trials, 1,035 of the 5,446 children administered a single dose of PROQUAD received a second dose of PROQUAD approximately three months after the first dose. The proportion of initially seronegative vaccinees with positive serological responses following two doses were 99.4 percent for measles, 99.9 percent for mumps, 98.3 percent for rubella and 99.4 percent for chickenpox. The rates of adverse experiences after the second dose were generally similar to, or lower than, those seen with the first dose. The fever rate was lower after the second dose of PROQUAD than after the first dose. The immunogenicity of PROQUAD was also evaluated in a clinical trial of 799 healthy children four to six years of age who had received M-M-R II and VARIVAX as primary vaccination against measles, mumps, rubella and chickenpox at least one month prior to study entry. In this study, 399 children received PROQUAD and placebo, 205 received M-M-R II and placebo concomitantly at separate injection sites and 195 children received M-M-R II and VARIVAX concomitantly at separate injection sites. Following the dose of PROQUAD, seropositivity rates were 99.2 percent for measles, 99.5 percent for mumps, 100 percent for rubella and 98.9 for varicella. The rates of adverse experiences, including the most commonly reported adverse experiences of injection site reactions, nasopharyngitis and cough, were generally similar among the three treatment groups. Formal studies to evaluate the clinical efficacy of PROQUAD have not been performed. Efficacy of the measles, mumps, rubella and chickenpox components of PROQUAD was previously established in a series of clinical studies with the monovalent vaccines. A high degree of protection from infection was demonstrated in these studies.
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