TALLINN - On Thursday, the first contract the European Commission has negotiated on behalf of the European Union member states with a pharmaceutical company entered into force 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 redirection to other European countries, the Commission said in a press release.
Through the contract, all 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.
The Commission continues discussing similar agreements with other vaccine manufacturers and has concluded successful exploratory talks with Sanofi-GSK on July 31, Johnson & Johnson on August 13, CureVac on August 18 and Moderna on August 24.
"The Commission is working non-stop to provide EU citizens with a safe and effective vaccine against COVID-19 as quickly as possible. The entry into force of the contract with AstraZeneca is an important step forward in this respect. I am looking forward to enriching our portfolio of potential vaccines thanks to contracts with other pharmaceutical companies and engaging with international partners for universal and equitable access to vaccination," President of the European Commission Ursula von der Leyen said.
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.
Thursday's contract is based on the Advanced Purchase Agreement approved on August 14 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 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 authorization 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 authorization 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.
Thursday's contract with AstraZeneca is an important step in the implementation of the European Vaccines Strategy, adopted by the Commission on June 17, 2020. This strategy aims to secure for all European citizens high-quality, safe, effective and affordable vaccines within 12 to 18 months.
To do so, and together with the member states, the Commission is agreeing Advance Purchase Agreements with vaccine producers reserving or giving the member states the right to buy a given number of vaccine doses for a certain price, as and when a vaccine becomes available.
Advanced Purchase Agreements are 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.
The European Commission is also committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it has raised almost 16 billion euros since May 4, 2020, under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery.