Coronavirus: the Commission signs second contract to ensure access to a potential vaccine
Today, a second contract with a pharmaceutical company entered into force following the contract’s formal signature between Sanofi-GSK and the Commission. The contract will allow all EU Member States to purchase up to 300 million doses of the Sanofi-GSK vaccine. Moreover, Member States may donate reserved doses to lower- and middle-income countries. Sanofi and GSK will also endeavour to provide a significant portion of their vaccine supply through a collaboration with the COVID-19 Vaccines Global Access (COVAX) facility – the vaccine pillar of the Access to COVID-19 Tools Accelerator for lower and middle income countries – in a timely manner.
The Commission has already signed a contract with AstraZeneca and continues discussing similar agreements with other vaccine manufacturers (Johnson & Johnson, CureVac, Moderna and BioNTech) with which it has concluded exploratory talks.
President von der Leyen said: “With today’s contract with Sanofi-GSK, the European Commission shows once again its commitment to ensuring equitable access to safe, effective and affordable vaccines not only for its citizens but also for the world’s poorest and most vulnerable people. Agreements with other companies will be concluded soon and build a diversified portfolio of promising vaccines, based on various types of technologies, increasing our chances to find an effective remedy against the virus.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “With several countries in Europe experiencing new outbreaks after the summer period, a safe and effective vaccine is more instrumental than ever to overcome this pandemic and its devastating effects on our economies and societies. This second agreement is yet another milestone in our EU Vaccine Strategy. Today we are expanding our possibilities to ensure that EU citizens and citizens around the world can gradually resume daily life and feel safe again.”
Today’s contract is financed by the Emergency Support Instrument, which dedicates funds to the creation of a portfolio of potential vaccines with different profiles and produced by different companies.
Sanofi and GSK are developing a recombinant vaccine for COVID-19, using innovative technology from both companies. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. GSK will contribute its adjuvant technology, of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore helping to protect more people. The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today to enhance the immune response. It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale.
The companies started a Phase 1/ 2 study in September, followed by a Phase 3 study by the end of 2020. If successful, and subject to regulatory considerations, the companies aim to have the vaccine available by the second half of 2021.
Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities to accelerate the authorisation and availability of successful vaccines against COVID-19. The regulatory processes will be flexible but remain robust. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.
Background
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 agreement will therefore allow investments to be made that otherwise would simply probably not happen.
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 on 31 August a contribution of €400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.
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