H1N1 Vaccine Approved by FDA for Children and Infants

CSL Limited’s 2009 H1NI flu vaccine was approved for children aged six months and older by the United States Food and Drug Administration (FDA) on November 12, 2009.

The vaccine received approval through the FDA’s accelerated approval regulation program, implemented to help a medication receive prompt approval to be available to treat life-threatening or serious illnesses.

Previously approved for use by those 18 years of age and older, the vaccine received approval for use by infants and children following a study that demonstrated the medication’s safety and efficacy.

“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 FDA Commissioner Dr. Margaret Hamburg.

According to the FDA, side effects associated with the use of the vaccine in children include pain, redness, swelling at the injection site, irritability, loss of appetite and drowsiness.  

Those allergic to eggs or egg products should not receive the vaccine as it contains a small amount of egg protein.