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Centers for Disease Control and Prevention


Vaccines & Immunizations

Hib Vaccine Recall and Shortage:
What Parents Need to Know

January 15, 2008

 

There has been a recall in the United States of over 1 million doses of “Hib” vaccine (Hib is short for Haemophilus influenzae type b). The recalled vaccines were made by Merck & Co., Inc. and distributed throughout the U.S. starting in April, 2007. Doctors have been told to stop using the recalled vaccines.

  • This vaccine recall is a precautionary step. The equipment used to make the vaccine is regularly sterilized before it is used. Merck recalled these doses of Hib vaccine because there was a possibility that some of the equipment was not fully sterilized before it was used. No contamination was found in the vaccine itself- the recall was a precautionary step.
  • All of the recalled vaccine passed all routine safety tests before being sent to doctors’ offices. Bacteria were not found in the vaccines themselves. No children have gotten sick as a result of receiving recalled vaccine.
  • The recall has caused a shortage of Hib vaccine in the U.S. Babies normally receive three or four doses of Hib vaccine between 2 months and 15 months of age (the number of doses depends on which brand of vaccine is used). In order to protect as many children as possible, CDC and its partners are asking all doctors to stop giving healthy children the booster dose of Hib vaccine at 12-15 months of age until this shortage is over. We do not think delaying this booster dose will put children at risk of getting Hib disease.
For parents of children who were given recalled Hib vaccine

We want to reassure parents that the recalled Hib vaccines passed all routine safety tests. No children have gotten sick as a result of possible bacterial contamination of these vaccines. If an infection were to occur, we would expect it to happen soon after vaccination (within about one week). Since the vaccine recall happened several weeks ago, we do not expect anyone to get sick.

If your child received recalled Hib vaccine, you do not need to have him or her vaccinated again. The strength and effectiveness of the recalled vaccines were fine, and gave your child the same amount of protection against Hib disease as the non-recalled vaccines.

For parents of children who are due for a Hib vaccine

CDC and its partners are asking all doctors to temporarily stop giving healthy children the booster dose of Hib vaccine at 12-15 months of age. We do not believe this will put your child at risk of getting Hib disease. Hib disease is a serious type of bacterial infection that can cause meningitis (an infection of the fluid around the brain and spinal cord), pneumonia (lung infection), and other serious infections. Because the current immunization rates in the U.S. for Hib disease are very high, the risk of this disease spreading is very low.

The diseases caused by Hib can be serious in children under age 1, so babies 6 months of age and younger need to get their first two or three doses of Hib vaccine. Once the shortage is over, these children should return to their doctors to get the booster dose as well.

Some children, including Native American and Alaskan Native children and children with certain medical conditions are at higher risk for Hib disease. Even during the shortage, these children should continue to receive all the recommended doses of Hib vaccine, including a booster dose.

 

For more questions and answers about the Hib vaccine recall, or questions and answers specifically for parents, visit http://www.cdc.gov/vaccines, or call (800) CDC-INFO (English and Español) or (888) 232-6348 (TTY).

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This page last modified on January 15, 2008
Content last reviewed on January 15, 2008
Content Source: National Center for Immunization and Respiratory Diseases

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