Merck Anticipates Shortage of Hepatitis B Vaccine

Merck expects an interruption of U.S. supplies this month for Recombivax HB, the adult formulation of its hepatitis B vaccine, including vials, syringes and dialysis formulations.

The vaccine supply for adults probably will be depleted during the first quarter of this year, but the company does not foresee any effect on the pediatric formulation, according to a Centers for Disease Control and Prevention (CDC) website on vaccine shortages.

The supply interruption “is a result of the need to upgrade some of the equipment used for bulk antigen manufacturing and a decision to prioritize the supply of the bulk for the pediatric formulation,” Amy Rose, a Merck spokeswoman, said. “The quality and safety of any of the Recombivax currently on the market is not affected.”
Drug GMP Report