On December 13, Merck initiated a voluntary recall in the United States (US) for 11 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) and stated that the return to market would be delayed.  This recall does not apply to any sanofi pasteur products.

To help manage this situation, the Centers for Disease Control and Prevention (CDC) in concert with other governing bodies, is recommending that providers temporarily defer the routine Haemophilus influenzae type b (Hib) vaccine booster dose typically administered at 12-15 months for healthy children. They also recommend that providers track children for whom the booster dose is deferred.  This will facilitate recalling them for vaccination when supply improves.  This temporary change in recommendations will help alleviate the market shortage situation.

The CDC does mention in their communication that sanofi pasteur Hib vaccines are unaffected in this recall.  They additionally point out that, alone, sanofi pasteur will be unable to meet the full market demand for the primary series plus a booster. 

Sanofi Pasteur is working closely with the CDC to assess inventory levels and production plans to use sanofi pasteur’s Hib vaccine, ActHIB^® (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), to maximize the benefit of the vaccine for the greatest number of children.  As the CDC evaluates inventory levels, they are also developing a distribution plan for the Vaccines for Children (VFC) program.