(Agencies)
Updated: 2007-12-13 20:07

Trenton, New Jersey - The recall of a routine vaccine for babies due to contamination risks could trigger a shortage and likely will alarm parents, but officials said there is no known health threat.

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

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

Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots.

"The potential for contamination of any individual vaccine is low," said Kelley Dougherty, a spokeswoman for the Whitehouse Station-based company.

Dr. 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.

Barbara Kuter, Merck's head of pediatric medical affairs, told The Associated Press that the company will not be able to supply any vaccine 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 next fall, she said.

"It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear.

Donna Cary, spokeswoman for Sanofi Pasteur, the only other company making the vaccine for the US, said it was too soon to say whether it can boost production. The company, a unit of Paris-based drugmaker Sanofi-Aventis SA, makes an Hib vaccine in France that is distributed both to the US and other countries.

"We're looking at what we can add and we're working closely with the CDC on this," to see whether some vaccine could be shifted to the US from other countries, Cary said.

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