FDA approves CSL H1N1 vaccines for use by infants and children
The US Food and Drug Administration (FDA) has approved the use of CSL's 2009 H1N1 influenza vaccine to include children aged six months and older. The vaccine was previously approved only for use in adults aged 18 years and older.
The US Food and Drug Administration (FDA) has approved the use of CSL's 2009 H1N1 influenza vaccine to include children aged six months and older. The vaccine was previously approved only for use in adults aged 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 Margaret Hamburg, FDA commissioner of food and drugs.
The Australian company's 2009 H1N1 vaccine is manufactured and tested using the same licensing processes that have been in place for many years for the company's seasonal flu vaccine. The expanded approval also covers the company's seasonal flu vaccine.
The FDA says approval was based on a study of CLT's seasonal flu vaccine in children, which showed the vaccine's safety and efficacy in protecting against influenza.
Because CSL's seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.
The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.
CSL said last month that it would donate three million doses of pandemic H1N1 2009 vaccine to the World Health Organisation for use in priority low-income countries in the South Pacific and South East Asia.