Common Children's Vaccine Recalled

By Mike Stobbe and Linda A. Johnson for the Associated Press.
http://www.theledger.com/article/20071212/APF/712120846

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.
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.
Drug maker Merck & Co., which announced the recall after testing this week showed 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.
Barbara Kuter, executive director of pediatric medical affairs for Merck, told The Associated Press that because of the contamination, the company's production line has been shut down 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 in the U.S., Sanofi Pasteur, may be able to produce more.
Health officials said they already are 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.
Health officials said they did not know how many of the 1.2 million doses were administered to children.
The recalled doses are considered potent, so children who got vaccine from the recalled lots will not have to be revaccinated, Schuchat said.
Parents will probably be concerned, CDC officials acknowledged. Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, a skin irritation around the vaccination site.
Problems could be worse for children with compromised immune systems.
Such problems would have appeared within one week of the vaccination, Schuchat said, adding that there have been no reports suggesting vaccine contamination so far.
The contamination involved unspecified equipment used in making the vaccine, which involves taking concentrated Hib virus, diluting it and combining it with other agents. Kuter said that during a routine evaluation of Merck's West Point, Pa., vaccine plant, a sterility test determined that the equipment was contaminated with a bacteria called Bacillus cereus, or B.
cereus.
It is a spore-making microorganism commonly associated with food poisoning and has caused diarrhea and vomiting in people who eat contaminated foods.
"It's one of the most common organisms" around, Kuter said.
The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.
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