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Today, after its official signature between Sanofi-GSK and the Commission, the second contract with a pharmaceutical company entered into force. The treaty will allow all EU member states to buy up to 300 million doses of the vaccine developed by Sanofi-GSK. In addition, Member States can donate a series of doses to low- and middle-income countries.
Sanofi and GSK will also seek to provide a significant portion of their vaccine supply in a timely manner through cooperation with the Global Vaccine Access Mechanism for COVID-19 (COVAX), the vaccine-linked pillar of the Access Tool. COVID. 19 for low- and middle-income countries. 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), ending exploratory talks, the EC press office said.
Commission President Ursula von der Leyen said: “With today’s agreement with SanofiGSK, the European Commission reaffirms its commitment to ensuring equal access to safe, effective and affordable vaccines not only for European citizens but also for the poorest and most vulnerable people in the world. . Agreements with other companies will be reached shortly and a diversified portfolio of promising vaccines based on different types of technology will be built, increasing our chances of finding effective means of protection against the virus. “
Stella Kiriakidou, Commissioner for Health and Food Safety, said: “As several countries in Europe are facing new outbreaks after the summer holidays, a safe and effective vaccine is considered more than ever the best way to overcome this pandemic and its devastating consequences for our economies and societies. This second agreement is another cornerstone of the EU vaccines strategy. Today we are expanding our capacity to ensure that EU citizens and people around the world can gradually return to their everyday life and feel safe. “
Today’s contract is financed by the emergency support instrument, which allocates funds for the creation of a portfolio of possible vaccines with different profiles, prepared by different companies. Sanofi and GSK are developing a recombinant vaccine for COVID-19 using innovative technologies from both companies. Sanofi will contribute the protein S antigen of the COVID-19 virus, which is based on recombinant DNA technology.
GSK will participate with its adjuvant technology, which is particularly important in the event of a pandemic as it can reduce the amount of protein in a single dose of vaccine, allowing more doses of vaccine to be produced and thus helping to protect more. persons. Combining a protein-based antigen with an adjuvant is well-established practice and is used in several currently available vaccines to enhance the immune response. It can also improve the likelihood of creating an effective vaccine that can be produced on a larger scale. The companies began stage 1/2 of their studies in September, followed by Stage 3 of the studies in late 2020. If these studies are successful and take regulatory considerations into account, the companies intend to make the vaccine available. available for the second half of 2021
Together with Member States and the European Medicines Agency, the Commission will use existing flexibility options to accelerate the authorization and availability of successful vaccines against COVID-19. Regulatory processes will be flexible, but will remain robust. Each vaccine marketed must meet the necessary safety requirements and be subject to scientific evaluation by the European Medicines Agency as part of the authorization procedure within the EU internal market.
On June 17, the European Commission presented a European strategy to accelerate the development, production and introduction of effective and safe vaccines against COVID19. In exchange for the right to buy a certain quantity of vaccine doses in a certain period, the Commission finances part of the initial costs of the vaccine manufacturers in the form of preliminary purchase agreements. The funding provided is seen as an advance on the vaccines that will actually be purchased by EU countries. Since the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk option for vaccine developers, these deals will allow investments that simply would not be possible under other circumstances.
The European Commission is also committed to ensuring that the vaccine is given to all people in need around the world, not just people at home. No one will be safe until we are all protected. Therefore, on May 4, 2020, the Commission raised nearly € 16 billion in global actions against the coronavirus for universal access to coronavirus testing, treatment and vaccines and global recovery, and reaffirmed its interest in participating in the COVAX mechanism for fair access to affordable COVID-19 vaccines around the world. As part of Team Europe’s efforts, the Commission announced on August 31 that it would provide € 400 million in guarantees in support of COVAX and its objectives in the context of global action against the coronavirus.
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