Hib vaccine for children recalled

January 1, 2008

On December 12, Merck voluntarily recalled approximately one million doses of its vaccines that help protect children from meningitis and other illnesses.

Eleven lots of the haemophilus b conjugate (PedvaxHIB) and two lots of the combination haemophilus b and Hepatitis B conjugate (Comvax) distributed in the US, as well as vaccine lots within the Centers for Disease Control and Prevention's (CDC) stockpile, are affected by this recall. Sanofi Pasteur also manufactures the vaccine, and has agreed to increase its production to compensate.

The presence of the bacteria B cereus was found during routine testing of Merck's manufacturing equipment. However, tests of the vaccine lots have not discovered any contamination. There have not been any vaccine-related problems reported through the Vaccine Adverse Event Reporting System. The affected doses were distributed in the US beginning in April 2007.

The CDC's press release, including a listing of the affected lots and instructions for returns, can be found at http://www.cdc.gov/vaccines/recs/recalls/hib-recall-faqs-12-12-07.htm.