SAVANNAH, GA – The Coastal Health District received some doses of the 2009 H1N1 vaccine from the lots that were voluntarily recalled today by vaccine manufacturer, Sanofi Pasteur. Less than 100 of the recalled single-dose, pre-filled pediatric syringes meant for children ages six to 35 months were distributed to health departments in the District’s eight counties including Bryan, Camden, Chatham, Effingham, Glynn, Liberty, Long, and McIntosh. Some of the vaccine has already been administered. Unused vaccine from the recalled lots will be returned to the manufacturer as requested.
There are no safety concerns with the recalled vaccine. According to the Centers for Disease Control and Prevention (CDC), all of the recalled lots successfully passed pre-release testing for purity, potency, and safety. The vaccine was recalled because testing by the manufacturer revealed that the antigen content in four lots of the vaccine had lower than required potency levels. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus“The vaccine that has been voluntarily recalled is perfectly safe,” said Dr. Diane Weems, Chief Medical Officer for the Coastal Health District. “The potency of the recalled vaccine is only slightly below the specified range and the vaccine in these lots is still expected to be effective.”
The CDC and U.S. Food and Drug Administration (FDA) are in agreement that because the recalled vaccine is still expected to provoke an immune response to the H1N1 flu, there is no need to revaccinate anyone who has received vaccine from the recalled lots. All children under 10 should receive two doses of H1N1 vaccine approximately one month apart. Therefore, children less than 10 years old who have only received one dose of vaccine thus far (whether it came from one of the recalled lots or not), should still receive a second dose of 2009 H1N1 vaccine.