NATIONS POSITION ON MENB VACCINE MARKET AUTHORIZATION
European position
The European Commission (EMA) granted a marketing authorization valid throughout the European Union for Bexsero on 14 January 2013.
United Kingdom interim position
The Joint Committee on Vaccination and Immunisation (JCVI) interim position statement sets out on July 2013 the outcome of the considerations of JCVI and its meningococcal sub-committee on the use of meningococcal B vaccine, in the UK. They concluded that, on the basis of the available evidence, routine infant or toddler immunisation using this new vaccine is highly unlikely to be cost effective at any vaccine price based on the accepted threshold for cost effectiveness used in the UK and could not be recommended.
Australian interim position
The Australian Therapeutic Goods Administration (TGA) has added on August 2013 the multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0,5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older.
Italian intermin position
The Italian Drug Agency (AIFA) on July 2013 stated the approval on market authorization.