Vaccine: Afluria
Company: CSL Limited
Approval Date: July 20
Protects Against: Influenza

The FDA green-lighted Afluria, an inactivated influenza virus vaccine manufactured by CSL Limited, July 20. Like many flu vaccines, Afluria protects against influenza virus subtypes A and B and is reformulated every season to match circulating strains of the flu. Back in 2009, Merck ($MRK) entered into an exclusive agreement with CSL Biotherapies, a subsidiary of CSL Limited, to market and distribute Afluria in the United States through the 2015-2016 flu season. The two companies have been partnered in the vaccine development and marketing business since 1980. CSL still holds rights to marketing the flu vaccine outside the U.S., where Afluria is sold as Fluvax. The FDA approved Afluria for the first time in 2007.

But not everything has been coming up roses for CSL and its influenza vaccine; a two-year study into the company's manufacturing process determined that excessive viral components in Fluvax triggered convulsions in some children in the 2010 dose. The FDA had sent a warning letter to the company in 2011 and confirmed results of the study in June 2012. Sales of Fluvax in 2010 were reported at $130 million, including $56 million in the U.S.

For more:
CSL confirms Fluvax manufacturing tied to convulsions in children
Vax maker CSL hit with FDA warning
CSL execs called to FDA over plant violations

Special Report: Major FDA vaccine approvals of 2012