Merck has said that the recall was issued because it can not assure 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. The affected doses of PedvaxHIB and Comvax were distributed starting in April 2007.
Mark Feinberg, vice president, medical and policy affairs, Merck vaccines and infectious diseases, said: “We are taking this action because we are committed to ensuring the quality of our vaccines. We know that our vaccines can play an important role in the nation’s public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available.”