The European Commission has presented its strategy in relation to COVID-19 vaccines

The European Union (EU) is challenged to succeed in the race to find a vaccine against Covid-19. On 17 June, the EU Commission presented its coronavirus vaccination strategy. Investments in research and development as well as in the expansion of production capacities must be made at an early stage. A centralised approach will prevent competition between Member States to find a vaccine. They have called for European solidarity.

Agreement within the Council

At the EPSCO Council on 12 June 2020, the health ministers of the federal states had previously signalled strong support for a uniform, European approach. In relation to this, sympathy was also expressed for the German, French, Italian and Dutch initiative to establish the "Inclusive Vaccine Alliance". For Germany, Federal Minister of Health Jens Spahn welcomed a determined and rapid action by the EU. He said that the Commission should play a leading role in the negotiations on a vaccine and conclude contracts with the industry quickly and pragmatically. Vaccine manufacturers can already take advantage of favourable financing offers from the European Investment Bank (EIB) to finance development and production. But a vaccine is not yet in sight.

Strategic objectives

The EU's vaccination strategy has three objectives: First, to ensure the quality, safety and efficacy of vaccines. Secondly, to ensure that the vaccine is quickly available to Member States. And thirdly, there should be equal access to vaccines in the EU and this should be at affordable prices.

Purchase guarantees are intended to secure production

On the one hand, the production of a sufficient quantity of vaccine is to be secured through Advanced Purchase Agreements (APA). The necessary financial resources are to come from the European Emergency Support Instrument (ESI). According to the Commission, a large proportion of the approximately 2.7 billion euros available in the ESI would be allocated for this purpose. In addition, funds will flow through Member States that wish to purchase specific quotas of vaccines. The Commission acts on behalf of the countries concerned. These countries are granted the right to purchase vaccine doses on the basis of the terms of the APA. A draft vaccine option contract has already been sent to the Member States and is currently under discussion.

Using the legal framework flexibly

On the other hand, the legal framework should be used in a flexible way to accelerate the development, authorisation and availability of vaccines, while maintaining standards of quality, safety and efficacy of vaccines. This includes, for example, initially imposing fewer requirements on the data situation in the initial approval process for drugs at the European Medicines Agency (EMA) and having these supplemented later. By involving a task force (ETF) at the EMA, the approval process can also be optimised in dialogue with the manufacturers through an early exchange of the scientific findings already collected. In addition, the periods for consultation of the Member States can be shortened or the labelling and packaging requirements can be applied flexibly.

Global action is required

The European initiative is in the context of global efforts to find a vaccine against COVID-19. Europe is involved in global organisations and alliances such as CEPI (Coalition for Epidemic Preparedness) or GAVI (Global Alliance for Vaccines and Immunisation). At the beginning of May this year, the Commission had already initiated a donor conference, the billions of euros of which are available for the research and development of a vaccine (see also Newsletter 5-2020). There is still no guarantee that a vaccine will be found anytime soon. Therefore, according to the Commission, the development of tests and treatments remains important.