Stella Kyriakides – Photo EC
(BRUSSELS) – The first pharmaceutical contract negotiated by the EU Commission on behalf of EU Member States entered into force Thursday following the formal signature between AstraZeneca and the Commission.
The contract will allow the purchase of a vaccine against COVID-19 for all the Member States of the EU as well as the donation to lower and middle income countries or the re-direction to other European countries.
Through the contract, all EU Member States will be able to purchase 300 million doses of the AstraZeneca vaccine, with an option for further 100 million doses, to be distributed on a population-based pro-rata basis.
Ongoing discussions continue over similar agreements with other vaccine manufacturers, with successful exploratory talks concluded with Sanofi-GSK on 31 July, Johnson & Johnson on 13 August, CureVac on 18 August and Moderna on 24 August.
AstraZeneca and the University of Oxford joined forces to develop and distribute the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.
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.
Today’s contract is based on the Advanced Purchase Agreement approved on 14 August with AstraZeneca, which will be financed with the Emergency Support Instrument. The “Inclusive Vaccine Alliance” countries (Germany, France, Italy, the Netherlands) who started negotiations with AstraZeneca asked the Commission to take over through an agreement signed on behalf of all Member States.
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 Commission says 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, while maintaining the standards for vaccine quality, safety and efficacy.
The necessary safety requirements and specific assessment by the European Medicines Agency as part of the EU market authorisation procedure guarantee that citizens’ rights will remain fully protected.
In order to compensate for such high risks taken by manufacturers, the Advanced Purchase Agreements provide for Member States to indemnify the manufacturer for liabilities incurred under certain conditions. Liability still remains with the companies.
