FDA approves 2010-2011 influenza vaccines; offers updates on Afluria

The FDA recently announced its approval of the seasonal influenza vaccines for 2010-2011 in the United States.

The brand names and manufacturers for the 2010-2011 influenza vaccine are:

Afluria (CSL Limited);
Agriflu (Novartis);
Fluarix (GlaxoSmithKline);
FluLaval (ID Biomedical Corp.);
FluMist (MedImmune);
Fluvirin (Novartis); and
Fluzone and Fluzone High-Dose (Sanofi-Pasteur).

CSL Limited’s Afluria has recently undergone labeling changes to notify health care providers about increased rates of fever and febrile seizure in young children, especially in those aged younger than 5 years. Labeling modifications were prompted by events observed after the vaccine’s introduction in the Southern Hemisphere.

Current data indicate higher incidence of these adverse outcomes are only associated with the Southern Hemisphere’s formulation of Afluria, and the FDA is requiring CSL Limited to conduct a study of Afluria in children to further investigate the cause of these febrile events. The agency is also working with Australia’s regulatory authority, other international regulatory counterparts and CSL to gather more information.

The FDA also announced that CSL Limited will not be providing the U.S. with the 0.25 mL single-dose, prefilled syringes that are used in very young children. However, the 0.5 mL single-dose, prefilled syringes and 5 mL multi-dose vials will be available.

In keeping with recommendations made by the Vaccines and Related Biological Products Advisory Committee’s meeting in February, all vaccine brands will contain three strains — A/California/7/09 (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus and B/Brisbane/60/2008-like virus — including the 2009 pandemic H1N1 influenza A virus.

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