AS the fight against Covid-19 continues in Ireland and around the world, the focus is firmly on finding a vaccine.
Now is a moment for science and solidarity, where we come together across Europe to pool our resources, capabilities and to face this challenge. It is not just a European one, but a global one.
None of us are safe until this virus has been completely eliminated and high-income countries have a responsibility to accelerate the development and production of a safe and effective vaccine and make it accessible for all the regions of the world. The EU recognises this task as its responsibility and Ireland must play its part too.
In June the Commission presented its EU Vaccines Strategy which has the following objectives:
Ensuring the quality, safety and efficacy of vaccines.
Securing swift access to vaccines for Member States and their populations while leading the global solidarity effort.
Ensuring equitable access to an affordable vaccine as early as possible.
The EU’s strategy is to mobilise the resources to find a vaccine to beat this virus once and for all. This means making sure we are ready to manufacture and deploy a vaccine, once it has been proven to work. It also means combining our purchasing power to ensure advance funding is available to develop the vaccine.
A complex and lengthy process
Vaccine development is a complex and lengthy process, which normally takes up to 10 years. It involves repeated rounds of clinical trials and serious investment is needed. This normally happens when there is a good chance of success, when the company carrying out the trial has weighed up the risks and is willing to run them. The failure rate in vaccine development is high and there is a very real risk that none of the supported candidates will be successful.
In this case however the urgency is too great; the time pressure is unprecedented. Every day gained could mean a life saved. So we are looking at a time frame of between 12 and 18 months. We need a safe and effective vaccine and that means running clinical trials in parallel with investing in production capacity and securing raw materials so that production can start as soon as those trials are concluded.
The EU entered exploratory talks with a number of pharmaceutical manufacturers over the course of the last few months. It has so far concluded talks to purchase a potential vaccine with 5 manufacturers. Moderna being the most recent with talks concluding on August 24. In July talks were concluded with Sanofi-GSK, in August with Johnson & Johnson and CureVac. The initial list of companies was determined by a series of factors including things like cost, speed, risk, capacity and soundness of scientific approach, it will be updated as additional information becomes available, in particular from the clinical trials.
The Commission will enter into agreements on behalf of Member States, including Ireland. In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price. This will be done in the form of advance purchase agreements (APAs). In August an Advance Purchase Agreement was signed with AstraZeneca, this is like a down-payment on the vaccines that will actually be purchased by Member States, to support companies in the swift development and production of a vaccine advance funding is provided.
The Irish government will take part in this EU scheme by paying several million euro as a deposit to give the country advance access to the Covid-19 vaccine being developed by the AstraZeneca and Oxford University.
Purchasing power, support and investment
The funding will come from the Emergency Support Instrument. The budgetary authorities, the European Parliament and the Council, have made EUR2.7 billion available. If additional funds are needed, Member States will have the possibility to top-up the ESI. The Commission is also providing guarantees to the European Investment Bank (EIB) under its financial instruments, such as Horizon 2020 InnovFin, the European Fund for Strategic Investments (EFSI) and the forthcoming InvestEU to support vaccine development.
Flexible but robust regulation
Developing a vaccine within short deadlines creates a challenge for the authorisation process but the system is flexible, which helps speed up the process. The regulatory process will need some flexibility whilst remaining robust, The focus will still be on producing a tested, safe and secure vaccine. Ensuring the highest quality and safety standards for citizens is always at the fore of EU research.
A testament to what partners can achieve
The circumstances we face require a bold response and joint action at EU level is the surest, quickest and most efficient way of achieving success. Though steps will be taken to mitigate the risk for example, by investing in a portfolio of companies covering different technologies, the risk of failure remains. However, the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided. This makes it a risk worth taking. This is the EU at its best: pooling resources, joining efforts, striving to bring tangible results to the everyday lives of people.