Merck & Co Inc. on Wednesday voluntarily recalled about
1.2 million doses of its widely used children's vaccines after quality-control
checks found production equipment may not have been properly sterilized.
The vaccines protect against Hib disease (Haemophilus
influenzae type b), which used to be the leading cause of bacterial meningitis
in children less than 5 years old, according to the U.S. Centers for Disease
Control and Prevention.
Merck said it recalled 11 lots of PedvaxHIB vaccine and two
lots of its Comvax vaccine due to lack of assurance of product sterility. Both
of the recalled vaccines protect against Hib and other conditions. 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 of the vaccine lots subjected to recall did
not turn up any contamination, said Merck, which added that the recall does not
affect any other vaccines it manufactures.
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.
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