Photo © European Union
(BRUSSELS) – The EU Commission reached first agreement with pharmaceutical company AstraZeneca Friday to buy a potential vaccine against COVID-19 as well as to donate to lower and middle income countries.
This follows positive steps regarding conclusion of exploratory talks with Sanofi-GSK announced on 31 July and with Johnson & Johnson on 13 August.
Once the vaccine has proven to be safe and effective against COVID-19, the Commission says it 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 Health Commissioner Stella Kyriakides said:”Today, after weeks of negotiations, we have the first EU advance purchase agreement for a vaccine candidate. I would like to thank AstraZeneca for its constructive engagement on this important agreement for our citizens. We will continue to work tirelessly to bring more candidates into a broad EU vaccines portfolio. A safe and effective vaccine remains the surest exit strategy to protect our citizens and the rest of the world from the coronavirus.”
The agreement is to be financed with the EU’s ‘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 EU executive says its 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.
