Europe's main medical regulator said it has adopted a positive opinion recommending the granting of a marketing authorization for Focetria, from Novartis AG (NVS) Vaccines and Diagnostics unit.
Focetria is a mock-up pandemic influenza vaccine, intended for the prevention of influenza during an officially declared pandemic situation, once the pandemic viral strain has been included. It is the second mock-up pandemic influenza vaccine to receive a positive opinion from the Committee.
Mock-up pandemic influenza vaccines are approved only for use in a declared pandemic influenza situation. The objective is to have a marketing authorization in place that can be changed quickly in the event of a pandemic to include the virus strain responsible, once it has been identified.
Source: Bio-Bio Technology