Merck recalls childhood vaccine

WASHINGTON (Dow Jones)–Merck & Co. is recalling about 1.2 million doses of a childhood vaccine used to protect against meningitis, pneumonia and other serious illnesses after the company found the equipment used to make the vaccine was contaminated with bacteria. The Whitehouse Station, N.J., firm has halted production of the vaccine and likely won’t resume production until the third quarter of 2008 and shipments until the fourth quarter, probably causing a temporary shortage of the widely used vaccine.

Julie Gerberding, the Centers for Disease Control and Prevention director, said there’s no health threat to children who may have received the recalled vaccine, known as the Hib vaccine. The recall involves vaccine 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. The Merck vaccine is made at a manufacturing plant in West Point, Pa.

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 SA is the other Hib vaccine provider. Anne Schuchat, the director of CDC’s immunization center, said Sanofi has agreed to step up its production of the Hib vaccine.

Donna Cary, a spokeswoman for Sanofi’s U.S. vaccine unit, said the company was working closely with the CDC but could not yet give estimates of how much additional vaccine the company could provide to the U.S. market.

The CDC said about 14 million Hib doses are needed annually to vaccinate children, which on average is supplied about equally by Merck and Sanofi.

Merck last year had a manufacturing problem related to its chickenpox vaccine that continues to hamper production of two other vaccines containing the same ingredient. A Merck spokeswoman said the Hib-vaccine issue involved the same Pennsylvania production facility, but different buildings within the facility, and that “the issues are completely different.”

(The reason this is listed on Retard News is that Merck was making a vaccine to help children, which wound up being something very unhealthy for children)