Merck Recalls Hib Vaccine

Hib Vaccine Recall
Georgia is among a number of states whose vaccine supply has been affected by the recent voluntary recall of 10 lots of Haemophilus influenzae type B (Hib) vaccine and two lots of a combination of Hib and Hepatitis B vaccine. The recall does affect the state’s vaccine supply but it does not have a negative impact on the health of Georgia’s children.

Revaccination of children who have received the affected Hib vaccine is not required at this time. No concerns have been raised about the effectiveness of the recalled vaccines. The vaccine is being recalled as a precautionary measure because the manufacturing company, Merck & Co., cannot assure sterility for the 10 lots. Sterility tests of samples from the recalled lots have not found any contamination. The potential for contamination of any individual doses of the Hib vaccine is very low.

Georgia received 66,430 doses of the affected Hib vaccine lots. However, only 32,990 doses were actually distributed. The Georgia Department of Human Resources, Division of Public Health has notified and distributed information to the Vaccines for Children program, Medicaid providers and the Georgia Chapter of the American Academy of Pediatrics about the recall. DHR has also placed an announcement about the recalled vaccine on the Georgia Registry of Immunization Transaction and Services (GRITS).

"We want people to know that this recall is not in response to any health threat for Georgia’s children," said Dr. Stuart Brown, Director of the Division of Public Health. "This recall is a preventive action Merck & Co. is taking to ensure the safety and health of the nation’s children. And kids who received the affected vaccine do not need to be revaccinated."

Merck & Co. initiated a voluntary recall on Wednesday in the United States for ten lots of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and two lots of COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]. The affected doses were distributed throughout the U.S. starting in April 2007.

Hib is a serious disease caused by bacteria that is commonly present in the nose and throat. It can be transmitted from person to person in droplets through sneezing and coughing. Infected children may carry Hib without showing any signs or symptoms of the illness; however, they can still spread the bacteria to others. Before the Hib vaccine, the disease was the leading cause of bacterial meningitis among children under 5 years old in the United States.