LONDON: A European medical regulator has recommended marketing rights for Swiss drug maker Novartis AG's bird flu vaccine for humans.
The Committee for Medicinal Products for Human Use, which reviews applications from drug makers for the 27-country bloc, has recommended to the European Commission approval for Novartis' Focetria as a vaccine in case of a pandemic flu caused by H5N1 avian flu virus.
The regulator had earlier given a similar approval to GlaxoSmithKline Plc's Daronrix.
The vaccines are described as "mock-up" vaccines, which have to be used as the base to produce the actual shot that will be given to people to protect themselves from the flu epidemic. These have to be further developed to include the correct virus strain that causes the infection, when it is officially declared as a pandemic. It cannot thus be stocked in large quantities.
Drug companies are now working on vaccines that can be readily used in the case of an outbreak caused by the H5N1 virus.
The recommendation will now be considered by the European Commission, which grants the license for vaccines. Normally, such recommendations are approved by the commission in a period of two to three months.
Novartis claimed in a press statement Focetria contains an additive that is meant to improve the body's immune response. It also facilitates use of smaller amount of viral antigens in each dose.
The H5N1 avian flu virus has so far killed more than 160 people since first reported in 2003.
