For Immediate Release
KDHE Office of Communications
The active ingredient in four lots of pediatric H1N1 vaccine is below the recommended level, but is still able to protect against infection with the pandemic flu virus, the Kansas Department of Health and Environment (KDHE) learned today from the Centers for Disease Control and Prevention (CDC). The active ingredient in the vaccine, also called an antigen, is what stimulates an immune response in an individual.
Manufacturer Sanofi Pasteur is conducting a non-safety related voluntary recall of the affected vaccine. The recalled vaccine comes in pre-filled syringes and is intended only for children 6 months through 35 months of age. A total of 3,700 doses of the recalled vaccine were distributed to 25 Kansas counties between November 9 and December 6. This comprises nine percent of the state’s total allocation of pediatric vaccine to date.
“There are no safety concerns with the recalled lots of the 2009 H1N1 vaccine. All lots successfully passed safety testing,” stated Dr. Jason Eberhart-Phillips, Kansas State Health Officer and Director of the KDHE Division of Health. “Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series, if this has not already been completed.”
The vaccine potency in the affected lots is still expected to be fully effective in preventing H1N1 flu. Children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine, about one month after the first dose.
The Kansas Immunization Program at KDHE has identified the local health departments and private providers that received H1N1 pediatric syringes from the four lots included in the voluntary recall, and is KDHE staff is currently following up with each of them.
Kansans who have questions about the recall can contact the CDC public response hotline at 1-800-CDC-INFO (1-800-232-4636) or the KDHE H1N1 hotline at 1-877-427-7317, or visit www.kdheks.gov/h1n1 and click on “Individuals, Families and Communities.”
Recalled vaccine was shipped to 50 providers in the following Kansas counties:
Allen, Brown, Butler, Chase, Chautauqua, Cherokee, Cowley, Crawford, Doniphan, Douglas, Elk, Greenwood, Jackson, Jefferson, Labette, Marshall, Montgomery, Morris, Nemaha, Neosho, Reno, Sedgwick, Shawnee, Sumner and Wilson.