FDA, CDC Announce Recall of Merck’s Hib Vaccine

Many people have debated the validity of childhood immunizations. But, what happens when those who do choose to vaccinate their children are faced with a vaccine recall? On December 11, 2007 the FDA and CDC initiated a recall of certain lots of the Hib vaccine due to bacterial contamination. Merck and Co., the drug company that produced the recalled vaccine, has issued a recall for 11 lots of PEDVAXHib and two lots of COMVAX. Specific information for the lots is below:

Product/Lot Number/Expiration Date

PedvaxHIB/0677U/01.11.2010
PedvaxHIB/0820U/01.12.2010
PedvaxHIB/0995U/01.16.2010
PedvaxHIB/1164U/01.18.2010
PedvaxHIB/0259U/10.17.2009
PedvaxHIB/0435U/10.18.2009
PedvaxHIB/0436U/10. 19.2009
PedvaxHIB/0437U/10.19.2009
PedvaxHIB/0819U/01.09.2010
PedvaxHIB/1167U/01.10.2010
COMVAX/0376U/01.05. 2010
COMVAX/0377U/01. 08.2010

Who is affected by Merck’s Hib Vaccine Recall?

The recall affects doses of the Hib vaccine that were first given to children in April 2007. At this time, no health problems or adverse effects have been reported due to the recall of the Hib vaccine. Should a child show symptoms within a few days of receiving the vaccine, parents should consult their doctor for further instruction. Symptoms of a contaminated vaccine include an abscess or bump near the area were the needle was injected. These symptoms differ from those normally associated with a Hib vaccination, like fever or warmth where the shot was given. If after a week your child does not show any symptoms, he or she is likely to be in the clear. Any child who has received one of the lots of vaccines listed above does not need to get revaccinated. The effectiveness of the vaccine has not been altered by the potential contamination.

Why is the Hib Vaccine important for children?

The Hib vaccine is meant to prevent Haemophilus influenza type b disease, which is a bacteria-caused disease that strikes children under the age of five. Bacteria are spread through germs to a child and, if spread to the bloodstream or lungs, can cause serious illnesses like bacterial meningitis and pneumonia. The U.S. Department of Health recommends that children should get Hib vaccine at two months, four months, six months, and 12 months of age. The Hib vaccine can be given in conjunction with other vaccines. Anyone who is younger than six weeks of age, who has ever had a serious or life-threatening allergic reaction to the Hib vaccine, or who are ill at the scheduled shot time. Children older than five years of age also do not need Hib vaccine, although anyone with sickle cell disease, HIV/AIDs, or other special health conditions should ask their doctor for it.

Sources:

FDA; Recall: Certain Lots of PedvaxHIB® [Haemophilus Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX® [Haemophilus Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
http://www.fda.gov/cber/recalls/merckhib121107.htm

CDC; Haemophilus Influenzae Type b (Hib) Vaccine: What You Need to Know
http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hib.pdf

Merck & Co., Inc.; Merck Announces Voluntary Recall of Certain Lots of PEDVAXHIB® and COMVAX®
http://www.merck.com/newsroom/press_releases/product/2007_1212.html