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CVMP reflection paper on the risks that should be considered prior to the use of unauthorised vaccin

Due to the epidemiological situation of major infectious diseases in neighbouring European countries as well as worldwide, there is a continuous risk of outbreaks of new diseases, many of them exotic, in EU Countries. Depending on the level of emergency, the use of vaccines as one of the most effective methods to prevent and manage infectious diseases can be of crucial relevance for the control of outbreaks or the eradication of diseases in livestock animals. Recent experiences have demonstrated the lack of any available authorised vaccines (vaccines with a marketing authorisation (MA) granted by a medicines regulatory authority in accordance with article 5 of Directive 2001/82/EC), when emergency vaccination may be required in the event of serious epizootic disease as stated in Article 8 of Directive 2001/82/EC. In the absence of such authorised products, the use of vaccines without a MA (hereafter referred to as unauthorised vaccines) can be provisionally allowed by Member States and should be considered in advance.

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