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

Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical.

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.