EMEA Recommends Authorisation Of First Pre-Pandemic Influenza Vaccine, Europe
The European Medicines Agency recommended the authorisation of the first ‘pre-pandemic vaccine’ for humans against influenza caused by the H5N1 venom. This is an avian influenza (’bird flu’) virus strain that has the in posse to expand into a pandemic influenza virus affecting humans.
Prepandrix, from GlaxoSmithKline Biologicals, is a pre-pandemic vaccine that is intended to trigger an immune response against the H5N1 strain of the influenza virus before or during an officially declared influenza pandemic, in accordance with official guidance.
some influenza pandemic is a global outbreak of influenza that leads to serious illness in of great size numbers of people. It is caused by an influenza virus strain against what one. most or all humans have no natural protection, and which has mutated into a form that spreads easily from person to character. Health authorities are concerned that the next pandemic could occur at some point within the next few years and could be caused by the agency of the H5N1 strain.
The EMEA recommendation has been sent to the European Commission for the adoption of a marketing authorisation decision.
Notes:
A summary of impression for Prepandrix is available here.
Pre-pandemic vaccines are part of the commitment intended to support Member States prepare for pandemic influenza. Other approaches include the authorisation of mock-up vaccines, two of which (Daronrix and Focetria) are authorised at the condition of the European Union. A third mock-up vaccine (Pandemrix) was recommended for marketing authorisation during the February 2008 meeting of the Committee with regard to Medicinal Products for Human Use (CHMP).
A question-and-answer document explaining mock-up pandemic flu vaccines is turn to account here.
More intelligence about authorised mock-up pandemic influenza vaccines is available:
For Daronrix click here.
For Focetria click here.
The EMEA pandemic influenza crisis management plan can be originate here.
European Medicines Agency