Afluria, a vaccine against seasonal influenza types A and B for people ages 18 and older, was approved using FDA’s accelerated approval pathway for serious or life-threatening diseases, which reduces the time for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination. CSL Limited is aiming to manufacture 2 million doses of Afluria this year for US distribution. Afluria is already marketed in 22 other countries.
