Media Release

For: Immediate Release
Date: December 13, 2007

Merck Announces Voluntary Recall of Hib Vaccine
HEALTH Quickly Notifies Pediatric Providers

Merck & Co., Inc. announced last night that the company has initiated a voluntary recall in the United States of twelve lots of its pediatric Hib vaccine. The recall is a precautionary measure due to manufacturing conditions that could have allowed contamination of the vaccine to occur. However, routine testing was performed before the lots were released and no contamination was found. The Centers for Disease Control and Prevention (CDC) does not believe that this situation presents any health threat to children. No reports of illness or infection have been reported in Rhode Island or anywhere in the United States.

About 6000 doses of the recalled vaccine were distributed to health care providers in Rhode Island through HEALTH. “We have an excellent system in Rhode Island, not only for tracking where vaccine is distributed, but also for informing our health care providers quickly about events like this,” said Director of Health, David R.Gifford, MD, MPH. “All pediatric providers have been notified of the recall and are returning all unused vaccine to the manufacturer.” HEALTH is working with health care providers to remove and replace affected Hib vaccine.

While there is no risk of serious health threats to children, there may be a risk that children who received the recalled vaccine could develop localized infection at the site of the injection. These infections are most likely to occur within one week after vaccination.  Parents of children who were recently vaccinated should look for redness and swelling and contact their providers if such reactions occur.  Children who were vaccinated with recalled vaccine will not need to be revaccinated, as the recall is not related to the efficacy of the vaccine in preventing Hib.

Hib vaccine is routinely given to infants starting at two months of age to prevent meningitis, pneumonia, and other infections throughout the body caused by a type of bacteria called Haemophilus. Because Hib can cause such serious illnesses and complications for children, routine recommendations for Hib vaccine administration will continue to be followed. CDC is still working to better understand how the recall will affect the vaccine supply.

Prior to the development of Hib vaccine in 1985, there were an estimated 20,000 cases of Hib disease annually in the US and 1,000 children died each year.  Today there are fewer than 100 documented cases of Hib disease annually. In the United States, vaccination coverage rates in young children are high---94% of toddlers nationwide are immunized.  In Rhode Island, Hib vaccination coverage rates among children are even higher than the national rates, exceeding 96% in 2006.
                       
For more information about the recall go to: www.cdc.gov/vaccines/recs/recalls/hib-recall-faqs-12-12-07.htm Merck also has a National Service Center that will answer questions about medical and other issues related to this recall, 1-800-672-6372.