WHO Prequalifies Three Influenza Vaccines From Novartis

Novartis has announced that the World Health Organization (WHO) has granted prequalification for all three of its influenza A(H1N1) 2009 monovalent vaccines for supply to the UN agencies.

The vaccines include the cell culture-based and MF59 adjuvanted vaccine, Celtura, the egg-based and MF59 adjuvanted vaccine, Focetria as well as the egg-based A(H1N1) vaccine manufactured using the seasonal Fluvirin platform. In addition to granting prequalified status for Novartis’ three influenza A(H1N1) 2009 vaccines, WHO has also granted prequalification for the company’s trivalent seasonal Fluvirin vaccine.

Celtura is an adjuvanted, cell culture-based, inactivated subunit influenza vaccine indicated for active immunization of persons six months of age and older, against influenza disease caused by the new A(H1N1) 2009 influenza virus. Celtura was approved for use in both Germany and Switzerland in November 2009, and Novartis is also seeking approval in a number of other countries.

Focetria is an adjuvanted, egg-based, inactivated subunit influenza vaccine indicated for active immunization of persons six months of age and older, against influenza disease caused by the new A(H1N1) 2009 influenza virus. Focetria was approved by the EU on September 29, 2009, for use in all 27 member states of the EU, plus, by extension, in Iceland, Norway and Liechtenstein through the European Economic Area (EEA) agreement. It is also licensed in a variety of other countries including Turkey, Switzerland, Tunisia and Croatia.

Novartis’ A(H1N1) vaccine from the Fluvirin platform is an unadjuvanted, egg-based, inactivated subunit influenza vaccine indicated for active immunization of persons four years of age and older against influenza disease caused by the new A(H1N1) 2009 influenza virus. The vaccine was approved for use in the US by the FDA on September 15, 2009.