Dec. 12, 2007 -- The CDC and FDA today announced the recall of 1.2 million doses of children's Haemophilus influenzae type b vaccine (Hib vaccine) due to concerns of product sterility.
No health problems have been reported, and no tainted vaccines have been found, says CDC Director Julie Gerberding, MD, MPH.
"Right now, this is not a health-threatening situation for children," Gerberding said at a news conference this afternoon. "We have had no cases of reported injury or adverse events with the Hib vaccine involved in this recall."
Advice for Parents
The recalled vaccines, made by the drug company Merck, are fully potent. Children who received the vaccines don't need to be revaccinated.
The concern is that the vaccine may be contaminated with bacteria, said Anne Schuchat, MD, director of the CDC's immunization center.
"No product has been found to have bacteria in it, but it is theoretically possible something slipped through," Schuchat said at the news conference.
Children who recently received the Hib vaccine may show symptoms at the injection site. Things to look for include local skin bumps or abscesses. Any problems would appear within a few days; after a week, problems are unlikely, says Schuchat.
Should symptoms appear, parents should contact a doctor.
About the Hib Vaccine
Every year, 14 million doses of the Hib vaccine are given in the U.S.
The Haemophilus influenzae type b vaccine (Hib vaccine) prevents serious bacterial infections, including:
The CDC recommends the Hib vaccine for all children under 5 years old in the U.S., with doses starting when children are 2 months old.
The Hib vaccine isn't related to the flu vaccine.
The CDC also recommends the Hib vaccine for some older children or adults with special health conditions including sickle cell disease, HIV/AIDS, spleen removal, bone marrow transplant, or cancer treatment with certain drugs.
Hib Vaccine Recall
The Hib vaccine recall involves 12 lots of PedvaxHIB and COMVAX.
"These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility," states the FDA's recall notice.
All of the recalled vaccines are made by Merck. Hib vaccines made by other companies aren't being recalled.
In a news release, Merck states that "the potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low." Merck states that it is conducting the recall because it "cannot assure the sterility of these specific lots of vaccine."
With additional reporting by Daniel J. DeNoon.