PedvaxHIB and COMVAX vaccines recalledMerck has voluntarily recalled ten lots of PedvaxHIB [Haemophilus b conjugate vaccine (meningococcal protein conjugate)] and two lots of COMVAX [Haemophilus b conjugate (meningococcal protein conjugate) and Hepatitis B (recombinant) vaccine]. Merck is conducting this recall because it can not assure the sterility of these specific vaccine lots. The twelve recalled lots were distributed starting in April 2007. This recall does not affect any other vaccines manufactured by Merck.
PedvaxHIB is indicated for vaccination against disease caused by Haemophilus influenzae type b in infants and children two to 71 months of age. COMVAX is indicated for vaccination against disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age born to HBsAg-negative mothers.
Physicians are advised not to administer any vaccine from the lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall. Furthermore, these patients do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected.
For more information call (800)672-6372 or visit www.merckvaccines.com.