Childhood Vaccine Contaminated, Recalled

Med Headlines - Merck & Co., makers of a common childhood vaccine, has recently recalled about a million doses of Haemophilus influenzae type b (Hib) because it may have become contaminated during manufacture. Infants as young as two months routinely receive Hib vaccinations to prevent pneumonia and meningitis. Hib is administered as a three-dose course of vaccination and is recommended for children under the age of 5.

A small portion of the recalled vaccines include vaccination against hepatitis B also.

Officials from Merck notified the Centers for Disease Control and Prevention (CDC) that the vaccine, marketed as PedvaxHIB, “was unavailable for shipment” until the first quarter of 2008. The interruption in shipments is attributed to a manufacturing issue.

Both the CDC and the US Food and Drug Administration (FDA) stress that the recall of the vaccines distributed before the manufacturing issue was discovered is a precautionary measure and that the vaccines in distribution pose no immediate threat to children’s health.

No contamination of the vaccine itself has been found, according to Merck, and there is no way to estimate how many doses of the recalled vaccine might have already been administered.

Health officials expect side effects no more serious than skin irritation around the site of the vaccine in healthy children, with symptoms appearing within a week of vaccination. More serious effects might be seen in children with impaired immune function.

The safety and efficacy of childhood vaccinations are the subject of growing debate across the country, with many parents and physicians expressing concerns that too many of them are now being required.

Filed under: Children's Health, Drugs, FDA, Recalls, Vaccinations