Regulatory Roundup: FDA Expands Use of CSL's H1N1 Vaccine to Children, Approves Fifth H1N1 Vaccine...

The US Food and Drug Administration announced on Nov. 12, 2009, that it approved the use of the CSL’s (Melbourne, Australia) seasonal and influenza A (H1N1) vaccines to include children ages 6 months and older. These vaccines were previously approved for use in adults ages 18 years and older. “Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of vaccines available for use in children is an important step in responding to the H1N1 outbreak,” Margaret A. Hamburg, commissioner of FDA, said in a press release. The vaccines will be available both in single-dose, preservative-free, prefilled syringes and in multidose vials that contain thimerosal, a mercury derivative, as a preservative.

In related news, FDA approved a fifth vaccine for protection against the influenza A (H1N1) virus. Manufactured by ID Biomedical (Quebec), which is owned by GlaxoSmithKline, the vaccine uses the “established, licensed egg-based manufacturing process used for producing seasonal flu vaccine,” according to an FDA release. ID Biomedical’s monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.