European Commission has reached a first agreement with AstraZeneca to purchase a potential vaccine against coronavirus as well as to donate to lower and middle income countries or redirect to other European countries
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Once the vaccine has proven to be safe and effective against coronavirus, the Commission now has agreed the basis for a contractual framework for the purchase of 300 million doses of the AstraZeneca vaccine, with an option to purchase 100 million more, on behalf of EU Member States.
The Commission continues discussing similar agreements with other vaccine manufacturers.
The agreement approved will be financed with the Emergency Support Instrument, which has funds dedicated to the creation of a portfolio of potential vaccines with different profiles and produced by different companies.
AstraZeneca's vaccine candidate is already in large-scale Phase II/III Clinical Trials after promising results in Phase I/II concerning safety and immunogenicity.
The decision to support the vaccine proposed by AstraZeneca is based on a sound scientific approach and the technology used (a non-replicative recombinant chimpanzee adenovirus-based vaccine ChAdOx1), speed at delivery at scale, cost, risk sharing, liability and the production capacity able to supply the whole of the EU, among others.
The regulatory processes will be flexible but remain robust. Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities in the EU's regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19. This includes an accelerated procedure for authorisation and flexibility in relation to labelling and packaging. ■
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