The EU Commission published its strategy for Covid-19 vaccines in June 2020, to ensure that vaccines are available to all EU citizens soon. To this end, the EU Commission has entered into Advanced Purchase Agreements with some vaccine manufacturers which allow the Member States to purchase a specified number of vaccine doses at a certain price, when a vaccine is available. The EU Commission has recently concluded talks with BioNTech-Pfizer to purchase a future vaccine against Covid-19. This envisaged contract would provide for the possibility for all EU Member States to purchase the vaccine, as well as to donate to lower and middle-income countries or re-direct to European countries.
To foster the development of Covid-19 vaccines, the European Union (EU) also considers easing some rules applicable to the package leaflet of future vaccines: Covid-19 vaccines could be exempted from the rule pursuant to which medicinal products distributed in the EU must have a patient leaflet in 24 languages (as complying with this rule may slow down the distribution of the vaccine doses). Discussions are also taking place in order to set up a specific compensation system in the event of adverse events after vaccination.
All these steps will make regulatory processes more flexible, but still strong. The EU Commission will take advantage of the flexibility already provided by the EU regulatory framework to speed up the authorization and availability of successful vaccines against Covid-19. However, manufacturers are very conscious of the importance to respect high standards of quality, safety and efficacy and already indicated that they would not botch up clinical trials.
The envisaged contract with BioNTech-Pfizer would provide for the possibility for all EU Member States to purchase the vaccine, as well as to donate to lower and middle income countries or re-direct to European countries