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Mississippi State Department of Health Responds to Voluntary Recall of PedvaxHIB® and COMVAX® Vaccines

From: MSDH News Release   Filed 12/13/07  GCN

Jackson, Miss. - Merck & Co. has voluntarily recalled approximately one million doses of its PedvaxHIB® and COMVAX® vaccines due to the possibility of bacterial contamination during manufacturing.  These vaccines are commonly used to protect children against Hemophilus influenzae b, which, before the vaccine was available, was a common cause of sometimes fatal meningitis among young children.  The vaccine is usually given to babies in their first 15 months of life.

The Mississippi State Department of Health (MSDH) is working with the manufacturer and the Centers for Disease Control and Prevention (CDC) to expedite this recall. MSDH distributed 20,870 doses of the affected lots to Health Department clinics and Vaccines for Children (VFC) providers throughout the state from August through November 2007. Of these doses, 7,030 went to health department clinics and 13,840 doses went to VFC providers.  The number of doses distributed through private sector channels in Mississippi is not known at this time.

Only vaccine from 12 lots is being recalled.  Vaccine from other lots can continue to be used.

“At this time, no vaccine has been found to be contaminated,” said State Health Officer Dr. Ed Thompson. “We have pulled all affected lots from our health department clinics and are joining the CDC and the manufacturer in advising all physicians who have received any affected lots to do the same.”

Children who have already received the vaccination do not need to be revaccinated; the potency of the vaccine in the recalled lots is not affected.  

According to State Epidemiologist Dr. Mary Currier, the worst case scenario for a child who received a possibly contaminated dose is redness, swelling or infection at the injection site.

“Any infection should occur within one week of receiving the vaccination. This means that if your child received a PedvaxHIB® or COMVAX® shot on or before December 6, and has had no infection to date, there is little cause for concern,” said Dr. Currier.

Children with the highest risk are those with compromised immune systems, such as those with sickle cell disease, leukemia or HIV.

Parents of recently vaccinated children who are concerned that their child may have an infection resulting from this vaccination should contact their physician.

While the recalled vaccine presents little or no risk to children who have been vaccinated, the recall signals a potentially serious problem with Hib vaccine supply. Merck has stopped production to sterilize its equipment and this closure presents significant problem for the national vaccine supply.

“There will likely be at least some degree of shortage of this vaccine in the coming months,” said Dr. Currier. “However, we will not know how severe the shortage will be until the CDC provides more information that will help us determine how to prioritize the distribution of available vaccine.”

Merck has a toll-free hotline, 1-800-672-6372, for questions and concerns about this recall.

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