Agriflu, a new vaccine to guard against the influenza virus subtypes A and B, has been granted approval by the US Food and Drug Administration (FDA).
The vaccine, manufactured by Novartis Vaccines and Diagnostics in Italy, was approved under the FDA’s accelerated approval process, which is dedicated to speeding up the availability of new drugs for serious or life-threatening diseases.
FDA Centre for Biologics Evaluation and Research’s Karen Midthun said that the approval is an important step in adding to the production capacity to enhance the vaccine supply for future US influenza seasons.
Accelerated approval was based on clinical studies that demonstrated the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.
Novartis is still required to conduct further studies to verify that the vaccine is effective.
Agriflu is administered as a single injection in the upper arm and is available in single-dose, pre-filled syringes that do not contain preservatives.