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Merck Recalls Children's Vaccines

Possible sterilization problems with 1.2 million doses

December 13, 2007    Spanish

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Merck & Co. is recalling about 1.2 million doses of its widely-used children's vaccines because of concerns that production equipment may not have been properly sterilized.

The recalled vaccines protect against a form of Influenza Type B, commonly known as Hib disease, which was once the leading cause of bacterial meningitis in young children, the U.S. Centers for Disease Control and Prevention said.

Merck said that 11 lots of PedvaxHIB vaccine and two lots of its Comvax vaccine were included in the recall. Both protect against Hib. Comvax also prevents hepatitis B.

The vaccines were manufactured in West Point, Pennsylvania, and distributed starting in April 2007. All but one lot was distributed in the United States, the company said.

Sterility tests found no contamination, Merck said, but quality-control tests found that some of the production equipment at the West Point plant may not have been properly sterilized.

"The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," Merck said.

Children who have received the affected vaccine do not need to be revaccinated because efficacy was not compromised, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

She advised parents to look for signs of infection at the site of the inoculation in the days following the injection.

Here is a complete list of the vaccines being recalled:

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