Europe's CHMP updates on pandemic vaccines, backs use extensions for Reyataz and RoActemra, concludes Seroquel XR arbitration

At its meetings last week, the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) reviewed further results from clinical studies and post-marketing experience for the centrally authorised pandemic influenza vaccines Celvapan (Baxter International), Focetria (Novartis) and Pandemrix (GlaxoSmithKline), as well as providing opinions on additional indications for several current drugs.

With regard to the vaccines, the CHMP said that marketing authorizations for these had been given under specific conditions. The Committee concluded that the additional data from clinical and non-clinical studies, from post-marketing surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area since September 2009 was sufficient to allow these vaccines to be given full marketing authorizations for their use outside a declared influenza pandemic. Under the terms of their current authorizations (exceptional circumstances) they can only be used in the context of a World Health Organization-declared pandemic. The Committee will continue to keep the vaccines under close surveillance. The product information of the three vaccines has been updated accordingly.

For Focetria, the CHMP recommended further changes to the product information to include data on the immunogenicity and safety in children aged six to 35 months and in those aged three to seven years. The available data indicate that a single full dose of Focetria vaccine triggered a good immune response in the younger age group, but that the second dose further increased the immune response. Furthermore, immunogenicity data in children aged three to seven years old suggests that a single dose may be sufficient.