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Vaccine Given To Babies Recalled Over Plant Sterility

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The Associated Press

Published: December 13, 2007

ATLANTA - More than a million doses of a common vaccine given to babies as young as 2 months were being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat.

The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children younger than 5 and usually is given in a three-shot series, starting at 2 months old.

Drug maker Merck & Co., which announced the recall after testing this week showed a sterility problem in a Pennsylvania factory, said concerned parents should contact their child's doctor.

"The potential for contamination of any individual vaccine is low," said Merck spokeswoman Kelley Dougherty.

Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.

"This is not a health threat in the short run, but it is an inconvenience," she said.

Merck produces about half of the nation's annual supply of 14 million doses of Hib vaccine.

Barbara Kuter, executive director of pediatric medical affairs for Merck, said that because of the contamination, the company's production line has been shut down for at least nine months.

"Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production in the fourth quarter of 2008, she said.

The effect on the public is unclear because the other company making the vaccine in the United States, Sanofi Pasteur, may be able to produce more, Kuter said.

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