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FDA & CDC Advise Public on Childhood Vaccine Recall

Two lots of Haemophilus influenzae vaccine recalled due to potential for contamination

THURSDAY, Dec. 13 (HealthDay News) -- Merck & Co. has voluntarily recalled 1.2 million doses of the Haemophilus influenzae type B (Hib) vaccine due to an error in manufacturing that could allow the potential for contamination. But the vaccine does not pose a health threat to children, announced officials from the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) this week.

Merck initiated the vaccine recall when it identified an error in a sterilization step during routine testing at a manufacturing plant in Pennsylvania. However, no examples of actual contamination have been found, health officials report. According to Anne Schuchat, M.D., the CDC's director of the National Center for Immunization and Respiratory Diseases, parents of recently vaccinated children can monitor the injection site for abscesses or red bumps, which may indicate a problem.

The Hib vaccine, which confers immunity against infections caused by the Haemophilus influenzae bacteria, is usually given in a three-shot series, starting at age 2 months. Because the recall has reduced the supply of available vaccine, the CDC is taking steps to alleviate any vaccine shortage.

Julie Gerberding, M.D., director of the CDC, reassured the public in a statement. "There have been no reported cases of adverse effects with the Hib vaccine," she said. "The recall has nothing to do with the potency of the vaccine, so children who have received the vaccine are protected," she said.

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