Flu Vaccine for Young Children Recalled December 16
Eight hundred thousand doses of H1N1 flu vaccine intended for young children aged 6 months to 35 months have been recalled, as periodic tests from early this month indicated that the vaccine was “not as potent as it should be”. It was stressed, though, that the recall does not mean that there should be concerns among parents regarding the safety of these vaccines.
The vaccines were produced by Sanofi Pasteur, which also tested the vaccines. According to company spokesman Len Lavenda, it takes between three to four months to make flu vaccine and most of that time is spent on testing. Sanofi Pasteur subjects the vaccine that it produces to a series of tests, both within the production process and after the process is completed. The vaccine has to pass end-of-phase tests before moving on to the next phase, and is again sent through a series of tests before it finally gets shipped out.
On top of these steps, Sanofi Pasteur keeps samples of each batch of vaccine that it produces and periodically tests these samples. The 800,000 doses of vaccine that is being recalled constitute four batches of vaccines that were shipped out from the Sanofi Pasteur manufacturing facility in Swiftwater, Pennsylvania in early November. At the time that the vaccines were shipped out, these had past all tests that had be done on them; however, in early December, tests conducted by Sanofi Pasteur indicated that the potency of these batches were 12% below the ideal potency level.
Sanofi Pasteur promptly informed the Centers for Disease Control and Prevention as well as the Food and Drug Administration about their findings. Sanofi Pasteur has been asked to retest their samples; it will reportedly take about a week to complete the tests.
Doctors are advised, though, to check their supply of vaccines and return vaccines that belong to the following lots to Sanofi Pasteur:
- 0.25 mL pre-filled syringes, 10-packs (NDC . 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB
- 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.