The CHMP has recommended the granting of a conditional marketing authorisation for a fourth pandemic vaccine, Arepanrix from GlaxoSmithKline Biologicals.
The recommendation was made using an emergency procedure that fast-tracks evaluation of new vaccines developed during a pandemic.
Further clinical studies in children, adolescents and adults are ongoing and results will become available from March 2010 onwards.
The Committee also reviewed further data on the three centrally-authorised pandemic influenza vaccines Celvapan, Focetria and Pandemrix and the antiviral Tamiflu.
Following a review of Celvapan studies in both children and adults, the Committee agreed that the studies did not support a change to a single-dose vaccination schedule. The Committee will continue to discuss this issue with experts and has requested further data from the manufacturer.
The Committee supported an update to the product information of Pandemrix to include additional data on the immunogenicity and safety in three- to nine-year-old children. Data is still being assessed on Focetria.
The Committee also recommended that safety data in immunocompromised subjects be added to the product information for Tamiflu.