Merck issues voluntary recall of pediatric vaccine

ATLANTA Merck is recalling about 1.2 million doses of a pediatric vaccine used to protect against meningitis, pneumonia and other serious illnesses after the company discovered the equipment used to make the vaccine was contaminated with bacteria, according to published reports.

Julie Gerberding, the director of the Centers for Disease Control and Prevention, said there was no health threat to children who may have received the recalled vaccine, known as the Hib vaccine. The recall involves vaccines that were shipped starting in April 2007.

Merck is one of two providers of the Hib vaccine, which is given to children in three doses, typically at the ages of two months, four months and 12 months. The vaccine is designed to protect against illnesses caused by the bacterium Haemophilus influenzae type B, and is unrelated to seasonal influenza, health officials said.

The recall involves 11 lots of a Hib vaccine, Pedvaxhib, and two lots of a combination vaccine for both Hib and hepatitis B sold under the brand name Comvax, Merck said.

Federal health officials said the recall is precautionary and there’s currently no evidence the vaccine itself was contaminated. However, Merck said because it could not assure the sterility of the vaccine it was recalling lots shipped from April through November. Sanofi Aventis is the other Hib vaccine provider. Anne Schuchat, the director of CDC’s immunization center, said Sanofi has agreed to increase its production of the Hib vaccine.

Merck likely won’t resume production until the third quarter of 2008 and shipments until the fourth quarter, most likely resulting in a temporary shortage of the widely used vaccine.