Negotiated Call for Tender for the Production and Supply of Pandemic Influenza Vaccines Surface Antigen, Inactivated, Adjuvanted with MF59, Propagated in Eggs, Monodoses

Description

A negotiated procedure for the production and supply of Pandemic Influenza Vaccines (PIV) was launched in April 2018. The pandemic influenza vaccines differ inter alia, by their biological/chemical composition, technical characteristics, manufacturing process, way of administration and primary packaging. Furthermore, they are recommended for specific groups of patients (depending on age and personal medical conditions) and therefore cannot be substitutes or reasonable alternatives for each other (in the meaning of Article 134 (3) of the Rules of Application of the Financial Regulation). Technical and market research conducted by the members of the SPPSC, with the support from experts from the Commission, the EMA and the ECDC showed that, for pandemic influenza vaccines surface antigen, inactivated, adjuvanted with MF59, propagated in eggs, monodoses there is only one manufacturer holding an EU-wide marketing authorisation. A negotiated procedure for the production and supply of Pandemic Influenza Vaccines (PIV) was launched in April 2018. The pandemic influenza vaccines differ inter alia, by their biological/chemical composition, technical characteristics, manufacturing process, way of administration and primary packaging. Furthermore, they are recommended for specific groups of patients (depending on age and personal medical conditions) and therefore cannot be substitutes or reasonable alternatives for each other (in the meaning of Article 134 (3) of the Rules of Application of the Financial Regulation). Technical and market research conducted by the members of the SPPSC, with the support from experts from the Commission, the EMA and the ECDC showed that, for pandemic influenza vaccines surface antigen, inactivated, adjuvanted with MF59, propagated in eggs, monodoses there is only one manufacturer holding an EU-wide marketing authorisation.