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DHS news release

Dec. 13, 2007

General contact: Patricia Feeny, 503-945-9073
Program contact: Lorraine Duncan, 971-673-0283

Health officials advise of partial Hib vaccine recall, no revaccinations required

Public health officials are advising Oregonians that the voluntary Haemophilus influenzae Type b (Hib) vaccine recall announced yesterday by Merck & Co., Inc., was taken as a precautionary measure.


Oregon received many of the recalled lots, according to the Oregon Department of Human Services Public Health Division. Providers were notified by DHS December 12 of the limited Hib vaccine recall.

"Children who may have received the vaccine are not at a serious health risk nor do they need to be revaccinated," said Lorraine Duncan, immunization manager in the DHS Public Health Division.

"The risk to people who received this vaccine is still theoretical, but the concern is the possibility of developing localized infection," Duncan said. "Any infection would occur within a week of vaccination, and people with low immune systems may be at the greatest risk of infection."

Duncan said if a child has received one of the recalled vaccines within the last week, parents should watch for any sign of localized infection around the injection site. If the area appears unusually red, painful or swollen, parents should call their child's health care provider. Otherwise, no action need be taken.

Merck has recalled 10 lots of PedvaxHIB (Haemophilus b Conjugate) Vaccine and two lots of COMVAX (Haemophilus b Conjugate), both of which contain Hib conjugate vaccine. The affected doses were distributed in the U.S. starting in April 2007. No other vaccine lots and no other Merck products are affected by this recall. These vaccines are given to children ages 2 months to 5 years to protect against meningitis, pneumonia and throat infections.

The recall stems from a standard evaluation that detected Bacillus cereus bacteria as part of its testing of the vaccine manufacturing process. Tests have not revealed any contamination in the vaccine itself, but Merck is recalling the product because they cannot ensure sterility of the specific lots in question.

Duncan said that health officials do not anticipate any reports of serious health effects to children who received the vaccine. The national Vaccine Adverse Event Reporting system (VAERS) will continue to monitor adverse events following vaccination as they are reported. No VAERS reports related to this recall have been received to date. Any potentially vaccine-related adverse events should be reported to VAERS at 1-800-822-7967 or at the VAERS Web site.

Providers should continue to use Hib vaccine not affected by this recall, according to current ACIP recommendations.

Providers who have recalled vaccine should return their product per the instructions in the Merck letter at the DHS Immunization Program Web site.

More information is available at the DHS Immunization Program Web site.