Today, the first contract the European Commission has negotiated
on behalf of the EU 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 re-direction to other European countries.
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 31 July,
Johnson & Johnson
on 13 August, CureVac on 18 August
and Moderna on 24 August.
Ursula von der Leyen, President of the European
Commission, said: “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.”
Stella Kyriakides, Commissioner for Health and Food
Safety, said: “Our negotiations have now delivered clear
results: a first contract signed delivering on our commitment to
ensure a diversified vaccine portfolio to protect the public
health of our citizens. Today's signature - made
possible by the important groundwork undertaken by France,
Germany, Italy, and the Netherlands - will ensure that
doses of a vaccine which, if proven effective and safe, will be
delivered across Member States. We expect to announce additional
agreements with other vaccine manufacturers very swiftly. “
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 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.
Background
Today's contract with AstraZeneca is an important step in the
implementation of the European Vaccines
Strategy, adopted by the Commission on 17 June 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 since 4 May 2020
under the Coronavirus Global
Response, the global action for universal access to tests,
treatments and vaccines against coronavirus and for the global
recovery.
