As Flu Season Approaches, Vaccines Ship to Distributors

Drug makers are responding to a greater anticipated need for flu vaccines by delivering shipments well in advance of the start of the 2010-2011 flu season.

Ahead of schedule, several drug manufacturers have already begun shipping lots of flu vaccines to vaccine distributors in anticipation of the 2010-2011 flu season. The vaccines were approved by the FDA and will protect against 3 strains of influenza, including the 2009 H1N1 pandemic flu, according to an announcement issued July 30, 2010.

The combination vaccine eliminates the need for the 2 vaccines that were required last year, when the 2009 H1N1 virus arrived after production of seasonal vaccine had already begun. In February, a panel of immunization experts from the Centers for Disease Control and Prevention (CDC) recommended annual influenza vaccination for all patients aged 6 months and older.

Based on projections by the FDA, World Health Organization, CDC, and other health organizations, this year’s vaccine will protect against strains most likely to cause illness, including:

• A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
• A/Perth/16/2009 (H3N2)-like virus
• B/Brisbane/60/2008-like virus

GlaxoSmithKline, Sanofi Pasteur, and Novartis are among the first drug companies to initiate distribution of flu vaccines following the FDA’s clearance. GlaxoSmithKline began with shipments of FluLaval, indicated for patients aged 18 and older, and will proceed with distribution of Fluarix—approved for use in adults and children aged 3 and older—in the coming weeks. The company expects to supply more than 30 million doses of the 2 vaccines this season.

Sanofi Pasteur’s first doses were shipped straight to the CDC for use by Vaccines for Children, a federal program that provides free vaccines to children aged 18 and younger whose parents are unable to pay for them. Sanofi Pasteur’s Fluzone is approved for use in children aged 6 months and older through adulthood, and is available for the first time in a high dose, indicated for adults aged 65 and older.

Novartis adjusted its manufacturing schedule to ensure early availability of its vaccine, Fluviron, which is safe for use in patients aged 4 and older. “Early vaccine delivery will ensure health care providers can protect as many individuals as possible against influenza, including those most at risk,” said Andrin Oswald, division head of Novartis vaccines and diagnostics.

For other articles in this issue, see:

• Drug Shortages the Worst in 30 Years, ISMP Reports
• FDA Finalizes Guidance for OTC Label Comprehension Studies
• Senate Measure Recognizes Value of Convenient Care