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Le Bonheur Children's Medical Center wants to ensure that all parents have access to information pertaining to the health and wellbeing of their children. Today, Merck & Co., Inc. announced that the Company is issuing a voluntary recall of 11 lots of its Haemophilus Influenzae type B vaccine, PEDVAXHIB Vaccine, and two lots of its combination Haemophilus Influenzae type B/hepatitis B vaccine, COMVAX Conjugate. The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of PEDVAXHIB and COMVAX were distributed in April, 2007. Merck is conducting this recall because it cannot assure the sterility of these specific vaccine lots. The potential contamination of these specific lots was identified as part of the Company's standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine. What are the risks to children who received vaccine from affected lots?
Sterility tests of the vaccine lots themselves have not found any contamination. Merck has not received any reports of abscesses or infection in children who received vaccines from affected lots. In addition, no problems have been detected by the Vaccine Adverse Event Reporting System (VAERS) related to the Hib vaccine affected by this recall. However, since sterility of the vaccine cannot be assured, if a child was vaccinated with a vial of PedvaxHIB that contained B. cereus or other microorganisms, there may be a risk of developing localized or disseminated infections. Immunocompromised children may be at greater risk for these infections. These infections are most likely to occur within one week after vaccination.
VAERS will continue to monitor adverse events following vaccination as they are reported. Merck and the Centers for Disease Control have information and further explanation of the recall posted on their websites. Parents can visit the following for more information.
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