Childhood vaccine is recalled over contamination risks

More than 1 million doses of a common vaccine given to babies as young as 2 months were being recalled Wednesday because of contamination risks, but the nation’s top health official said it was not a threat.

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

The recall is for 1.2 million doses of the vaccine for Hib, or Haemophilus influenza type b, 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.

Drug maker 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,” Merck spokeswoman Kelley Dougherty said.

Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, echoed that point 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 would 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 effect on the public was unclear because the other company that makes the vaccine for the U.S., Sanofi Pasteur, may be able to produce more.

Health officials said they were talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases.

The officials said they did not know how many of the 1.2 million doses had been administered to children.

The recalled doses, which were distributed beginning in April, are considered potent, so children who got the vaccine from the recalled lots will not have to be revaccinated, Schuchat said.