Closer to a Sustainable solution of the pandemic: Authorisation of COVID-19 Vaccines for Europeans

European Commission’s authorisation for a new contract with CureVac will be the fifth contract to secure another COVID-19 vaccine. The Commission recently approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States.





On 16 November, Commission President von der Leyen made a statement on CureVac which states that a new contract to secure another COVID-19 vaccine for Europeans will be authorised. This will be the fifth contract with pharmaceutical companies regarding the COVID-19 vaccine.


The highlights of President von der Leyen’s statement are as follows:

“The coronavirus continues to spread rapidly across Europe. We need a safe and effective vaccine to end this pandemic. A few days after our contract with BioNTech and Pfizer, I am happy to announce a new agreement. Tomorrow (17 November), we will authorise a new contract to secure another COVID-19 vaccine for Europeans. This contract allows us to buy up to 405 million doses of a vaccine produced by the European company CureVac.


Earlier this year, we have provided funding to CureVac, together with the European Investment Bank. We did that to support the development of this vaccine. And now, progress is tangible. If the vaccine has proven safe and effective against COVID-19, every Member State will receive the vaccine at the same time, on a pro-rata basis, and under the same conditions.


This is the fifth contract with a pharmaceutical company for our COVID-19 vaccine portfolio. And we are working on a sixth one, with Moderna. We have already concluded exploratory talks with Moderna. We hope to finalise the contract soon.”

On 11 November, the European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

The contract with the BioNTech-Pfizer alliance builds upon the broad portfolio of vaccines to be produced in Europe, including the already signed a contracts with AstraZeneca, Sanofi-GSK and Janssen Pharmaceutica NV and the concluded successful exploratory talks with CureVac and Moderna. This diversified vaccines portfolio will ensure Europe is well prepared for vaccination, once the vaccines have been proven to be safe and effective.


President of the European Commission, Ursula von der Leyen, said:

“In the wake of Monday's (9 November) promising announcement by BioNTech and Pfizer on the prospects for their vaccine, I'm very happy to announce today's (11 November) agreement with the European company BioNTech and Pfizer to purchase 300 million doses of the vaccine. With this fourth contract we are now consolidating an extremely solid vaccine candidate portfolio, most of them in advanced trials phase. Once authorised, they will be quickly deployed and bring us closer to a sustainable solution of the pandemic.”


BioNTech is a German company working with US-based Pfizer to develop a new vaccine based on messenger RNA (mRNA). mRNA plays a fundamental role in biology, transferring instructions from DNA to cells' protein making machinery. In an mRNA vaccine, these instructions make harmless fragments of the virus which the human body uses to build an immune response to prevent or fight disease.

The Commission has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, the companies' experience in vaccine development and their production capacity to supply the whole of the EU.


Background

In June, the European Investment Bank (EIB) and BioNTech concluded a € 100 million debt financing agreement to allow the company to expand its manufacturing capacity in order to supply their vaccine quickly worldwide. The financing is backed by the European Fund for Strategic Investments and also benefits from InnovFin Risk Sharing for Corporate Research backed by Horizon 2020.


The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements. Funding provided is considered as a down-payment on the vaccines that will actually be purchased by Member States.


Since the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers, these agreements will therefore allow investments to be made that otherwise might not happen.


Once vaccines have been proven to be safe and effective and have been granted market authorisation by the European Medicines Agency, they need to be quickly distributed and deployed across Europe. On 15 October, the Commission set out the key steps that Member States need to take to be fully prepared, which includes the development of national vaccination strategies. The Commission is putting in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies.

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 and has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere. As part of a Team Europe effort, the Commission announced is contributing with €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.