Vaccine recalled over contamination concerns

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. A shortage of the widely used vaccine appeared possible, though.

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 under 5 and is usually given in a three-shot series, starting at 2 months old.

Drugmaker Merck & Co., which announced the recall after this week identifying 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.

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.

Merck produces about half of the nation's annual supply of 14 million doses of Hib vaccine. It said sample vials from the recalled lots, tested before shipment, were not found to be contaminated but the company was unable to assure sterility of the entire lots.

Barbara Kuter, executive director of pediatric medical affairs for Merck, told The Associated Press that because of the contamination, 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 in the fourth quarter of 2008, 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 because the other company making the vaccine for the U.S., Sanofi Pasteur, may be able to produce more.

However, Sanofi Pasteur spokeswoman Donna Cary said Wednesday night that it was too soon to say whether that is possible. The company, a unit of Paris-based drugmaker Sanofi-Aventis SA, makes an Hib vaccine in France that is distributed both to the U.S. and other countries.