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Information about the Hib Vaccine Recall

North Carolina’s Haemophilus influenzae type B (Hib) vaccine supply has been affected by the recent voluntary recall of 10 lots of Hib vaccine and two lots of a combination Hib and Hepatitis B vaccine. While the recall does affect the state’s vaccine supply, it will not require reimmunization of children who have received the affected vaccine.

The State’s Universal Vaccine Program received and shipped 86,610 doses from the affected lots of Hib vaccine. The State program does not distribute the combination vaccine. Providers who have received recalled vaccines are in the process of being contacted and are being asked to immediately discontinue use of any of the affected lots and to return the recalled vaccine to the manufacturer.

CDC is not recommending revaccination of children in this situation. There is no evidence that the effectiveness of this vaccine has been compromised. As a precautionary measure, parents whose children have recently received a dose of the recalled vaccine should watch for any signs of infection such as redness and swelling at the injection site within seven days of receiving the vaccine. If an unusual reaction is noticed, parents should contact their doctor or health care provider.

There has been no increase in reported adverse events nationally or in North Carolina associated with this recalled vaccine. If you are aware of any adverse events, please report them through the VAERS website at www.vaers.hhs.gov.

The vaccine is being recalled as a preventative measure because the manufacturing company, Merck, cannot assure sterility of the ten lots. Sterility tests of samples from the recalled lots have not found any contamination and the potential of contamination of any individual dose of vaccine is very low.

 


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Link: N.C. Women's and Children's Health Web Site

North Carolina’s vaccine supply of Hib has been significantly reduced. The nationwide Hib vaccine recall is expected to cause a shortage in North Carolina. The extent to which this recall will impact our vaccine supply is being determined and is dependent upon the availability from the other manufacturer.

Current immunization rates in the U.S. for Hib vaccine are high. In 2006, about 94% of U.S. children 19-35 months of age were vaccinated against Hib. For North Carolina, the immunization rate is even higher, at 99.7% for the same age group. This has resulted in a dramatic decline in transmission of this disease; however, it has not gone away completely.

The letter from Merck below provides more information about this recall and instruction on the return process for vaccine involved. Providers are asked to compare their current vaccine supply against the list of recalled lot numbers, and remove any affected lots from your supply. Any recalled vaccine should be prominently marked “DO NOT USE – RECALLED VACCINE.” It is not necessary to keep recalled vaccine refrigerated. Lots involved in the recall include:

PRODUCT DESCRIPTION
LOT #
EXP. DATE
PedvaxHIB®
0677U
11 January 2010
PedvaxHIB®
0820U
12 January 2010
PedvaxHIB®
0995U
16 January 2010
PedvaxHIB®
1164U
18 January 2010
PedvaxHIB®
0259U
17 October 2009
PedvaxHIB®
0435U
18 October 2009
PedvaxHIB®
0436U
19 October 2009
PedvaxHIB®
0437U
19 October 2009
PedvaxHIB®
0819U
09 January 2010
PedvaxHIB®
1167U
10 January 2010
COMVAX®
0376U
05 January 2010
COMVAX®
0377U
08 January 2010

If people have questions or concerns about this vaccine recall, please contact your physician, your local health department, or the State’s Universal Vaccine Program at 919-707-5550.

Additional Information on Hib and the vaccine recall:

 

 


Last Updated: January 14, 2008

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Personal medical advice should be sought from your local health department or physician.

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