Baby vaccine recall may cause shortages

ByABC News
December 13, 2007, 2:02 AM

— -- More than 1 million doses of a commonly used vaccine for infants have been recalled because of contamination at the plant where the shots are made, federal health officials said Wednesday.

The recall doesn't pose a health risk but may result in shortages, officials said, because vaccine maker Merck has stopped production and does not expect to be able to resume shipments before October 2008. The vaccine protects against Hemophilis influenzae type b, or Hib, which can cause meningitis, pneumonia and other illnesses. It is usually given to babies at 2 and 4 months old, with a booster at 12-15 months.

"This is not a health threat in the short run, but it is an inconvenience," said Julie Gerberding, director of the Centers for Disease Control and Prevention. About 14 million doses of the vaccine are made each year in the USA, half by Merck and half by Sanofi Pasteur, said Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases. To help meet demand, she said, the CDC will dip into its stockpile of 750,000 doses of Hib vaccine and, with the Food and Drug Administration, is talking with Sanofi Pasteur about increasing its production.

The recall involves 10 lots of its Hib vaccine, PedvaxHIB, and two of a Hib-hepatitis B combination vaccine, COMVAX, produced at its plant in West Point, Penn. Michael Thomas, Merck's vice president for vaccines, said that during routine testing, the company found the equipment used to make the vaccine was not fully sterilized. "We've not found any contamination in the vaccine," he said, and no reports of children harmed.

Children who already have received the recalled vaccine won't need follow-up care, Schuchat said. If the vaccine were to cause health problems, there probably would be swelling or an abscess at the injection site within a week of immunization.

Contributing: Rita Rubin, USA TODAY