December 13, 2007 Vaccine Recall Includes Over 3,000 Doses in Louisiana

BATON ROUGE, Dec 13, 2007 - Louisiana’s vaccine supply has been affected by the recent voluntary recall of 10 lots of Haemophilus influenzae type B (Hib) vaccine and two lots of a combination Hib and Hepatitis B vaccine.  The children’s vaccine is being recalled as a preventive measure because the manufacturing company, Merck, cannot assure sterility for the lots involved.

“We want to stress that this is not a health threat for the children of Louisiana,” said Dr. Roxane Townsend, LDH Secretary.  “Tests of the recalled vaccine lots have not found any contamination and there have been no reports of adverse reactions due to the vaccine.  Children who received the vaccine from affected lots do not need to be revaccinated.”

About one million doses nationwide are believed to be affected by the recall.  The Department of Health – Office of Public Health has identified one of the affected lot numbers in Louisiana, from which a total of 3,360 doses were distributed to Vaccines For Children (VFC) providers.  It is PedvaxHIB vaccine lot number 0677-U, expiration date January 11, 2010. 

VFC providers who have received the recalled vaccine are being contacted and asked to immediately discontinue use of the affected lot, and return the vaccine to the VFC Program.

“As a precautionary measure, parents whose children have recently received a dose of the recalled vaccine should watch for any signs of redness, swelling or an abscess at the injection site within a week of vaccination,” said Dr. Frank Welch, medical director of the Immunization Program.  “If they notice an unusual reaction, they should contact their doctor.”

As a result of this recall, providers who only use Merck’s Hib vaccines may have none, some or all of their vaccine recalled, and about half of the Hib vaccine in the CDC’s stockpile is being recalled.  Immunization Program Director Ruben Tapia said, “Many states are anticipating shortages of Hib vaccine because of this recall.  In Louisiana, we’re expecting similar challenges.” 

The Hib vaccine is recommended for all children under five years old in the U.S. and is usually given to infants starting at two months old.  It prevents meningitis and other serious bacterial infections.