The Centers for Disease Control and Prevention (CDC) has announced a non-safety-related recall of certain lots of Sanofi Pasteur H1N1 pediatric (0.25 mL, for 6-35 month olds) vaccine in pre-filled syringes. The physician practices of St. Joseph Hospital have received limited amounts of these doses.
There are no safety concerns with these doses of H1N1 vaccine. The vaccines successfully passed pre-release testing for purity, potency and safety. The recall was announced because some of the doses tested after release were slightly below the "specified" range of potency.
The CDC is recommending that the shots do not need to be re-administered to those who received the vaccine from this supply. It is recommended that all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still plan to receive a second dose of 2009 H1N1 vaccine.
For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials has not experienced this drop in potency and meets all standards of safety, purity and potency. As with all multidose vials of vaccines, these multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened.
For more information on the CDC recall click here.