FDA approves H1N1 child, infants vaccine

November 16, 2009 - 0 comments

Washington -- The U.S. Food and Drug Administration says it has approved an Australian drug manufacture's H1N1 flu vaccine to include children ages 6 months and older.

The CSL Ltd. vaccine was previously approved only 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 children's vaccines available is an important step in responding to the H1N1 outbreak," said Dr. Margaret Hamburg, FDA commissioner.

The federal agency said the vaccine's approval was based on a study of the company's seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza.
Those efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Because CSL's seasonal and H1N1 vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products, the FDA said.

Both vaccines are manufactured by CSL Ltd. of Melbourne, Australia.