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 Approximately 1 million doses of 2 childhood vaccines have been recalled by Merck & Company, Inc, because of potential contamination, the US Food and Drug Administration (FDA) advised healthcare professionals this week.
The voluntary recall involves 11 lots of Haemophilus influenzae type b (Hib) vaccine (Pedvax Hib) and 2 lots of Hib/hepatitis B vaccine (Comvax) that were shipped after April 2007. The same products manufactured by Sanofi Pasteur are not affected.
According to Merck, routine testing of equipment used to make the vaccine identified the presence of a pathogen (Bacillus cereus). Although subsequent testing revealed no contamination of individual doses, their sterility cannot be ensured, and healthcare professionals are advised not to administer any vaccine from these lots.
"The kinds of things that parents who have recently had their children immunized with either the PedvaxHIB or Comvax [vaccines] might look for are local skin bumps or abscesses at the site of injection; those kinds of things might emerge...up to about a week after vaccination," said Anne Schuchat, MD, director of the Centers for Disease Control and Prevention's (CDC's) National Center for Immunization and Respiratory Diseases in a December 12 news conference.
"[T]his is right now not a health-threatening situation for children; we have had no cases of reported injuries or adverse events associated with the Hib vaccine that's involved in this recall," noted CDC Director Julie Gerberding, MD.
Because vaccine potency is not affected, children who have already received the vaccine do not need to be reimmunized, Dr. Gerberding said, adding that overall Hib coverage is estimated to be 92%, and meningitis outbreaks are not anticipated.
However, the recall will cause "a great inconvenience," because doses currently in physicians' offices will have to be returned. In addition, the CDC stockpile will lose some of the 750,000 doses set aside for shortages.
"I think we do expect there to be a shortage in terms of a mismatch between supply and demand," said Dr. Schuchat. "The extent of that is what we are trying to sort out."
In the interim, healthcare professionals are urged to continue following current recommendations for routine childhood vaccination. Doses will be available from the CDC stockpile, and Sanofi Pasteur has committed to increase vaccine production.
Additional information regarding the recall may be obtained by contacting the Merck National Service Center at 1-800-672-6372.
Hib vaccine is indicated for routine vaccination of infants and children aged 2 to 71 months against invasive disease caused by H influenzae type b, such as meningitis, pneumonia, and severe throat infections. Hib/hepatitis B vaccine is indicated for vaccination against invasive disease caused by H influenzae type b and against infection caused by all known subtypes of hepatitis B in infants aged 6 weeks to 15 months born to HBsAg-negative mothers.
Adverse events potentially related to these vaccines should be reported to the Vaccine Adverse Event Reporting System by telephone at 1-800-822-7967 or online at http://www.vaers.hhs.gov, and to Merck by telephone at 1-800-672-6372.
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