“Today, September 18, a second contract with a pharmaceutical company entered into force, following its official signing by Sanofi-GSK and the Commission. The contract will allow all EU member states to purchase up to 300 million doses of the vaccine produced by Sanofi-GSK. In addition, Member States may donate reserved doses to low- and middle-income countries. Sanofi and GSK will also strive to provide a significant share of their vaccine supply in a timely manner through a collaboration with the Global Access to Vaccines Mechanism against COVID-19 (COVAX) – the vaccine pillar in the access to tools to combat COVID-19 for low- and middle-income countries, ”the EC announced.
The Commission has already signed a contract with AstraZeneca and continues to discuss similar agreements with other vaccine manufacturers (Johnson & Johnson, CureVac, Moderna and BioNTech), with which it has concluded exploratory talks.
“Through today’s contract with Sanofi-GSK, the European Commission reiterates 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 will soon be reached with other companies and a diversified portfolio of promising vaccines will be developed, based on several types of technologies, which will increase our chances of finding an effective remedy against the virus “, says EC President Ursula von der Leyen.
Friday’s contract is funded by the Emergency Support Instrument, which dedicates funds to creating a portfolio of potential vaccines with different profiles, produced by different companies.
“Given that a number of European countries are facing new outbreaks after the summer, a safe and effective vaccine is more important than ever to overcome this pandemic and its devastating effects on our economies and societies. This second agreement is another important step in the EU Vaccination Strategy. Today, we are expanding our opportunities to ensure that EU citizens and citizens around the world can gradually resume their daily lives and begin to feel safe again, “said Stella Kyriakides, Commissioner for Health and Food Safety.
Sanofi and GSK are developing a recombinant vaccine against COVID-19, using innovative technologies from both companies. Sanofi will contribute the COVID-19 protein S antigen, which is based on recombinant DNA technology. GSK will contribute with its adjuvant technology, which is particularly important in a pandemic situation, as it can reduce the amount of protein needed per dose, allowing more doses of vaccine to be produced and thus helping to protect more people.
The combination of a protein antigen and an adjuvant is well documented and used in a number of currently available vaccines to enhance the immune response. It can also improve the likelihood of developing an effective vaccine that can be manufactured on a large scale.
The companies started a phase 1/2 study in September, which will be followed by a phase 3 study by the end of 2020. If these steps are successful and subject to regulatory considerations, companies aim to put the vaccine at risk. available to the public until the second half of 2021.
“Together with the Member States and the European Medicines Agency, the Commission will use existing flexibility mechanisms to accelerate the authorization and availability of effective vaccines against COVID-19. Regulatory processes will be flexible, but will remain robust. Any vaccine placed on the market will have to meet the necessary safety requirements and be subject to scientific evaluation by the European Medicines Agency as part of the authorization procedure in the EU market, ”the EC said.
On 17 June, the European Commission presented a European strategy to accelerate the development, manufacture and distribution of effective and safe vaccines against COVID-19. In return for the right to purchase a certain number of doses of vaccine in a given period of time, the Commission finances part of the initial costs incurred by vaccine manufacturers in the form of pre-purchase commitments. The funding provided is considered as an advance for vaccines that will actually be purchased by Member States.
“As the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers, this agreement will allow for investments that would otherwise not be possible. be carried out “, say the EC representatives.
The European Commission is also committed to ensuring that anyone who needs a vaccine can get it, anywhere in the world and not just at home. No one will be safe until we are all safe. That is why, since 4 May 2020, the Commission has raised almost € 16 billion in the global response to the coronavirus crisis, global action for universal access to coronavirus testing, treatment and vaccines, and for global economic recovery and confirmed its interest in participating in the COVAX mechanism for equitable access to affordable COVID-19 vaccines worldwide. Also as part of a Team Europe effort, the Commission announced on 31 August a € 400 million contribution in the form of guarantees to support the COVAX mechanism and its objectives in the context of the global response to the coronavirus crisis.