The United States Food and Drug Administration (FDA) has approved the 2009 H1N1 vaccine for use in children 6 months and older, according to an FDA news release. This H1N1 vaccine, manufacturer by CSL Ltd. of Australia, was previously approved only for use in adults aged 18 years and over.

According to Margaret A. Hamburg, M.D., commissioner of food and drugs, “….having a broader range of [H1N1 vaccines] available for use in children is an important step in responding to the H1N1 outbreak.”

H1N1 vaccine was manufactured and tested using the same licensing processes that have been in place for many years for the company’s seasonal flu vaccines. The approval for this H1N1 vaccine was based on a study of the company’s seasonal flu vaccine in children. The study showed that the vaccine is safe and able to induce protective antibodies against influenza. In cases of serious or life-threatening disease, the FDA has a process of accelerated approval in order to make safe and effective medical products, such as this H1N1 vaccine, available to the public more quickly than usual.

Common side effects of the H1N1 vaccine in children include pain, redness, and swelling at the injection site and, in some cases, irritability, drowsiness, and poor appetite. And, like CSL’s seasonal flu vaccine, the H1N1 vaccine contains a small amount of egg protein, so it should not be given to anyone who is allergic to eggs or egg products.

Source:

U.S. Food and Drug Administration News Release, 12 November 2009.