The Utah Department of Health (UDOH) today announced more than 2,000 doses of the recently recalled Haemophilus influenzae type B (Hib) vaccine were received and shipped in Utah since April 2007. The vaccine's manufacturer, Merck, voluntarily recalled 11 lots of the Hib vaccine and two lots of a combination Hib and Hepatitis B vaccine.

"The recalled vaccine does not have a negative effect on our children's health, nor will it require revaccination of children who have received the affected vaccine," said Karen Tsuyuki, vaccine management coordinator, Utah Immunization Program. "Further, the nationwide recall is not expected to significantly impact Utah's supply of Hib vaccine."

The Utah Immunization Program is in the process of contacting providers who have received recalled vaccines and are asking them to immediately discontinue use of any of the affected lots and to return the recalled vaccine to the distributor or manufacturer.

Merck initiated the voluntary recall due to the potential for bacterial contamination in these specific lots. The problem was identified during standard evaluation of their manufacturing processes. The vaccine is being recalled as a preventive measure because Merck cannot assure sterility for the 11 lots. However, sterility tests of samples from the recalled lots have not found any contamination and the potential for contamination of any individual dose of vaccine is very low.

"The important thing to understand is that this is not a health threat for the children of Utah," said David Sundwall, executive director, Utah Department of Health. "Also, we can assure parents that children who received vaccine from affected lots do not need to be revaccinated."

As a precautionary measure, health officials recommend parents whose children have recently received a dose of the recalled vaccine watch for any signs of infection, such as redness and swelling at the injection site within seven days of receiving the vaccine. If parents notice an unusual reaction, they should contact their doctor or health care provider.

Hib vaccine protects against meningitis (an infection of the covering of the brain and spinal cord), pneumonia (lung infection), epiglottitis (a severe throat infection) and other serious infections caused by a type of bacteria called Haemophilus influenzae type b. The vaccine is recommended for all children under five years of age in the United States and is usually given to infants starting at two months of age.

The Hib bacterium is commonly present in the nose and throat. Bacteria are spread from person to person through sneezing and coughing. Infected children may carry Hib bacteria without showing any signs or symptoms of illness, but they can still infect others. The risk of disease is highest for children between six months and two years of age. Before Hib vaccine, about 20,000 children in the United States under five years of age contracted severe Hib disease each year and nearly 1,000 died.

Merck's voluntary recall covers lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine].

The affected doses were distributed starting in April 2007. No other lots of PedvaxHIB® or COMVAX® and no other Merck products are affected by this recall.

For more information, contact your health care provider, local health department or the Utah Immunization Program at 1-800-275-0659.

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