Merck Recalls More Than a Million Doses of Hib Vaccine

Although top U.S. health official say it is not a health threat, Merck & Co. has recalled 1.2 million doses of the vaccine for Hib. The vaccine protects children against pneumonia, meningitis, and other serious infections. It is a three-shot series usually given to children younger than 5 years old, starting when they are 2 months old.

The recall was issued after a sterility problem was discovered in a Pennsylvania factory. Sterility testing performed on equipment in the plant showed that it was contaminated with a bacteria called Bacillus cereus, or B. cereus. Merck spokeswoman Kelley Dougherty said that parents should contact their doctor if they are concerned that their child might have been given the vaccine. However, said Dougherty, "the potential for contamination of any individual vaccine is low."

Health officials do not know how many of the recalled doses were administered to children before the recall was announced. But the doses are considered to be viable and any children who were vaccinated from the recalled doses will not have to be revaccinated.

Merck produces about half the annual supply of Hib vaccine doses for the United States, so the impact on the public cannot be determined yet. The company’s production line has been shut down for nine months.

"It’s likely that there’s going to be a shortage of this product," said Barbara Kuter, executive director of pediatric medical affairs for Merck. The only other company producing the vaccine in the United States is Sanofi Pasteur.

If the vaccine is proven to have been contaminated, health officials say the worst side effect for most children will be a skin irritation around the site of the vaccination. Children with compromised immune systems may have more severe problems.