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January 2008 Merck officials recalled 11 lots of their Haemophilus influenzae type b vaccine and two lots of their combination Haemophilus influenzae type b/hepatitis B vaccine last month. The manufacturer elected to conduct a recall of lots of the Hib conjugate (PedvaxHIB) and Hib combination (Comvax) vaccines that were distributed starting in April because it could not assure their sterility. Officials said that although sterility tests have not found any contamination, some of the lots could potentially have become contaminated during manufacturing processes. “This is right now not a health-threatening situation for children. We have had no cases of reported injuries or adverse events associated with the Hib vaccine that’s involved in this recall,” Julie Gerberding, MD, MPH, director of the CDC, said during a CDC/FDA media advisory teleconference addressing the recall. “It’s also important to understand that this recall has nothing to do with the potency of the vaccine, so children who receive this vaccine are protected against Hib,” she added. “We do recognize, unfortunately, that this is going to cause a great inconvenience. This vaccine is currently in physicians’ offices … so it will be a lot of checking and some inconveniences, at best, in terms of sustaining our successful immunization program.” The recall will also affect the CDC’s vaccine stockpile for public use, and flexibility for future ability to backfill for vaccine shortages has been lost, according to Gerberding. Overall, approximately 14 million doses of the nation’s supply will be affected by the recall, according to Anne Schuchat, MD, director of the National Center for Immunization and Respiratory Disease. “Although this is not a health threat, it certainly poses some challenges for parents and for doctors,” Schuchat said. “We are working closely together with Merck and Sanofi [Pasteur], the company that also makes Hib vaccine that is not affected by the recall. We’re also working closely with public health and providers to decrease the interruptions in practice that might occur.” On Dec. 19, the CDC issued a Morbidity and Mortality Weekly Report Dispatch with a set of interim recommendations in response to the expected shortage. Physicians are now recommended to temporarily defer the routine Hib booster vaccine typically given to children aged between 12 and 15 months, except in children at high risk for invasive Hib disease. The recommendations also encourage physicians to track those patients for whom vaccination was deferred so that they can continue the vaccine series in these children once the shortage is resolved. Pediatricians should report any adverse events to the Vaccine Adverse Events Reporting System. For more information: |
