Stefan De Keersmaecker: Building trust in vaccines is fundamental

Where our health is in danger, our economies are in danger

A strong European Health Union will protect our health, but also our ways of living, our economies and societies. Where our health is in danger, our economies are in danger. The close relation between saving lives and saving livelihoods has never been so clear, Stefan De Keersmaecker, European Commission Spokesperson, says in an interview to EUROPOST.

Mr De Keersmaecker, an unprecedented in EU history vaccination campaign has been launched. The European citizens expect from the EC to ensure full transparency and safety. How will these expectations be met?

In our 15 October Communication on the preparedness for Covid-19 vaccination and vaccines deployment, we called for the development and implementation of clear communication campaigns, in order to tackle misinformation and to build citizens' trust in our vaccines. These campaigns, at Member State and Commission level, are rolled out and should help tackling vaccines hesitancy.

It is important to explain to citizens that, before being made available for purchase and use, any Covid-19 vaccine candidate has to meet the requirements and evidence thresholds of the European Medicines Agency's (EMA) scientific assessment to receive market authorisation.

Building citizens' trust also requires transparency of the safety assessment process. This is why the clinical data submitted by the vaccine developer in the marketing authorisation for every vaccine will be published after marketing authorisation. This includes the clinical trial reports, whether they were conducted in the EU or in third countries.

In addition, EMA will publish the product information (in English) as soon as it has prepared its opinion on the request for market authorisation. It will also publish the European Public Assessment Report - the report containing public information on the vaccine, including how it was assessed by EMA - within three days after the European Commission granted the EU marketing authorisation.

The full Risk Management Plans (RMP) - plans that the companies have to submit on the vaccine's safety profile and explaining how its risks will be prevented or minimised in patients - will also be made public for every vaccine.

The Commission has been negotiating tirelessly with vaccine manufacturers having promising vaccine candidates, and we have concluded six Advance Purchase Agreements to secure access to vaccines for EU citizens, whilst negotiations with others are still ongoing.

Is the financing fully secured?

The joint objective is to obtain a broad portfolio of vaccine candidates that contain different technological approaches to achieve the highest possible chances of a successful Covid-19 vaccine. A uniform EU approach on the portfolio is of capital importance, allowing at the same time to achieve better deals and conditions than would otherwise be possible for any individual country.

The Commission made about €2.15 billion ESI funding available for this purpose, in return for the right or obligation for Member States to buy a specified number of vaccine doses in a given timeframe and at a given price. Moreover, Member States have agreed to contribute with additional €750 million.

 Are you ready to prevent the expected misuse through counterfeit deliveries, for which warnings have been raised?

Interpol issued a global warning alerting that organised crime networks could try to sell counterfeit Covid-19 vaccines or attempt to steal vaccines. The distribution chain is safe in the European Union thanks to several controls carried out by all actors in the supply chain, such as manufacturers, distributors of vaccines and healthcare professionals. Moreover, all prescription medicines shall bear safety features composed of a unique identifier and an anti-tampering device.

The European Union has also a network of competent authorities who can react very quickly in case a falsified or counterfeit medicine is discovered in the supply chain.

Scientists say that vaccines will not stop the coronavirus pandemic if the people who get them are not sufficient in number. Do you have already data on how many European citizens do not want to be vaccinated, and how will you persuade them to do it?

Confidence in vaccines is a complex matter and has been challenged for years, in Europe and the rest of the world. Building trust and public confidence is fundamental. We have seen this with new outbreaks of vaccine-preventable diseases, such as measles, in many countries. It should be stressed that a new Covid-19 vaccine could be our only real exit from the pandemic, and that no corners will be cut in terms of safety, despite the current speed of vaccine development. As I already said, before being made available for purchase and use, any Covid-19 vaccine candidate needs to meet the strict requirements and evidence thresholds of the European Medicines Agency's scientific assessment to receive market authorisation. Information and communication efforts should involve health professionals as trusted sources in vaccination matters.

In addition, such efforts should effectively address vaccine hesitancy, often fuelled by mis- or disinformation online. They should be targeted and take the needs of different population groups into account.

Again, vaccines don't save lives. Vaccinations save lives.

Can the Covid-19 vaccination campaign be considered as a step forward in the process of building a European Health Union?

The experience of the current pandemic shows that coordination and cooperation between Member States and the Commission are crucial. The pandemic is both an EU wide and global problem that can only be tackled if we work together. The EU Vaccines Strategy clearly demonstrated the added value of EU level cooperation.

With the support of the European Parliament and the Council, the EU must therefore be better equipped to prevent, prepare for and manage health crises. Only a stronger Health Union, with all the societal and economic benefits it brings, is up to the task.

A strong European Health Union will protect our health, but also our ways of living, our economies and societies. Where our health is in danger, our economies are in danger. The close relation between saving lives and saving livelihoods has never been so clear. By building a stronger Health Union, the proposals put forward today will contribute to a more resilient EU internal market and sustained economic recovery.

The Commission's ambitions for a Health Union are presented in the midst of a widespread resurgence of Covid-19 cases across Europe and the world. At the same time, improving preparedness and response for future outbreaks of communicable diseases is more pressing as such outbreaks become more likely. Indeed, long-term trends such as antimicrobial resistance, pressures on biodiversity and climate change, all associated with increasing communicable disease threats worldwide and in Europe, keep rising.

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Stefan de Keersmaecker is European Commission Spokesperson for Health, Food Safety and Transport. Before joining the EU institutions 19 years ago, he worked as a lawyer in international law firms.

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