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FOR IMMEDIATE RELEASE Thursday, Dec. 13, 2007
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CONTACT Mark W. Salley |
Children’s Hib Vaccine Recalled by ProducerDENVER-Yesterday, pharmaceutical company Merck & Co.
recalled approximately 1 million doses of a children’s Haemophilus b
Conjugate (Hib) vaccine as a preventative measure due to “lack of
assurance of product sterility.” Providers are advised not to administer
any additional doses of the recalled vaccine. The U.S. Centers for
Disease Children who received the vaccine do not need to be revaccinated, according to CDC recommendations. Doses from the recalled lots were distributed in Colorado to private physicians and public clinics through the Vaccines for Children (VFC) program. Hib disease is a serious bacteria that is the leading cause of bacterial meningitis. The recalled vaccines are
Ned Calonge, chief medical officer at the Colorado Department of Public Health and Environment, said, “There is no safety or health concern for children who have received the vaccine. The recall is a precautionary measure due to manufacturing conditions that could have allowed contamination to occur. Importantly, no adverse events have been reported following vaccination with the recalled vaccine.” Calonge added, “Thankfully, the Hib vaccine has been very successful in decreasing the prevalence of this disease in the community, so we have at least a little time to address the vaccine shortage and get children adequately immunized.” According to the CDC, if a child received contaminated vaccine, adverse reactions would include localized reactions around the site of vaccination and likely would be identified within one week after vaccination. As a result of this recall, providers who use only Merck Hib vaccines may have none, some or all of their vaccine recalled. There are two U.S. Hib vaccine manufacturers: Merck & Co., Inc. and sanofi pasteur. In the past, each manufacturer has produced about half of the nation’s Hib vaccine supply. The CDC is assessing availability of Hib vaccine and timing of future supply and will make appropriate recommendations soon. Children at increased risk for Hib include: children with sickle cell disease, leukemia and malignant neoplasms; HIV and certain other immunocompromising conditions; asplenia; as well as American Indian and Alaska Native children. Vaccinating these children according to the recommended schedule is a high priority. According to Joni Reynolds, immunization program director at the Colorado Department of Public Health and Environment, “This vaccine recall will be especially inconvenient for providers as there will be an inadequate vaccine supply. While the two vaccines are completely interchangeable, there are different administration schedules. The Colorado Immunization Program is available to assist clinicians with questions or concerns at 303-692-2650.” Providers who have recalled vaccine should return their product to Merck & Co. For information, the public and providers can visit the U.S. Food and Drug Administration Web site http://www.fda.gov/cber/recalls/merckhib121107.htm or the Merck & Co. Web site http://www.merck.com. ---30--- |
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