European Union and safe vaccines against COVID-19

Ursula con der Leyen

Rome [ENA] 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. The COVID-19 pandemic is inflicting huge human and economic costs on the European Union and the world. A permanent solution to this crisis is most likely to be brought about by the development and deployment of an effective and safe vaccine

against the virus. The scale of the crisis means that time pressure is unparalleled : every month gained in the deployment of a vaccine will save many lives, many jobs and many billions of euros. In whatever way, the quest for a vaccine against COVID-19 is particularly challenging due to the urgency of the issue. Vaccine development usually takes more than 10 years. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission would finance part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements. Funding provided would be 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 would simply probably not happen. On 31st July the European Commission has concluded exploratory talks with a pharmaceutical company to purchase a potential vaccine against COVID-19. The envisaged contract with Sanofi-GSK* would provide for an option for all EU Member States to purchase the vaccine. It is expected that, once a vaccine has proven to be safe and effective against COVID-19, the Commission would have an established contractual framework for the purchase of 300 million doses, on behalf of all EU Member States.

Sanofi-GSK's vaccine candidate is planning to seek marketing authorisation from EMA in June 2021, following Phase III clinical trials yielding the induction of a promising immune response. The Commission continues intensive discussions with other vaccine manufacturers. President von der Leyen said: “The European Commission does all in its power to ensure that Europeans have rapid access to a vaccine that is safe and protects them from coronavirus. Today's step with Sanofi-GSK is a first important cornerstone of a much broader European Vaccines Strategy. More will follow soon. We are in advanced discussions with several other companies.

While we do not know today which vaccine will work best in the end, Europe is investing in a diversified portfolio of promising vaccines, based on various types of technologies. This increases our chances to obtain rapidly an effective remedy against the virus. A vaccine would be a truly global good. We are committed to help secure access also for more vulnerable countries to find their way out of this crisis.” Stella Kyriakides, Commissioner for Health and Food Safety, said: “A safe and effective COVID-19 vaccine is the surest exit strategy from the crisis. For that reason, we have been negotiating a united EU approach to secure doses of promising vaccine candidates in recent weeks. Today's announcement of the conclusion of exploratory

talks with Sanofi-GSK is the first important step in this direction, to provide equal access to the vaccine for our citizens.” The exploratory talks concluded on 31st July are meant to result in an Advance Purchase Agreement to be financed with the Emergency Support Instrument, which has funds for the creation of a portfolio of potential vaccines with different profiles and produced by different companies.    The European Commission is also bound to the policy of 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.  The Commission is also exploring with international partners if a significant number of countries would agree to pool resources for jointly reserving future vaccines from companies for themselves as well as for low and middle-income countries at the same time.

The high-income countries could act as an inclusive international buyers' group, thus speeding up the development of safe and effective vaccines and maximise access to them for all who need it across the world. Only very swift and unified action by the EU and its Member States will ensure sufficient and speedy supplies of a safe and effective vaccine.