“We underestimated the difficulties of vaccination”

La Croix: The contracts signed by the Commission on behalf of the 27 Member States of the European Union (EU) are the subject of much criticism. What lessons do you take from it and what would you do differently today?

Ursula von der Leyen: If I look back, the central question has been whether we are going to have a vaccine. Normally it takes five to ten years to find a vaccine, so all the attention was focused on developing it. I remember that more than 100 companies or researchers applied to benefit from European support in this race. What I realize, looking in the rearview mirror, is that we should have thought more, in parallel, about mass production and the challenges it poses. The industry has never suddenly embarked on such a gamble …

→ EXPLANATION. Delays in vaccine delivery: what has the European Union obtained from laboratories?

To increase volumes, to set up new supply chains sufficiently upstream, we could have done it earlier. Now, we are working with industry to prepare for the possibility of variants of the coronavirus that can resist vaccines. We must immediately support science, so that vaccines are adapted as soon as possible. Because the best lesson learned in recent months is that you never know what will happen in a year. We must be prepared for all eventualities.

Is solidarity at 27 to the detriment of agility in decision-making in an emergency situation?

U. V. D. L. : Alone, a country can be a speedboat, while the EU is more like a ship. Before concluding a contract with a pharmaceutical company, the 27 Member States had five full days to say whether they agreed or not. This naturally delays the process. Indeed, we must constantly put pressure on ourselves so that each step of the decision-making process is as fast and efficient as possible.

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But I am absolutely convinced that the European approach is the right one. On these vaccines, we worked faster than usual. I can’t even imagine what it would have meant for Europe, in terms of unity, if one or more Member States had access to vaccines and the others did not… From an economic point of view too, we had to work on 27, because otherwise restarting the economy would have been impossible. Our economies, our production chains depend so much on each other!

If there were delays, they can be explained primarily by the approach to vaccine safety and efficacy: the conditional marketing authorization procedure, in conjunction with the European Agency medication (EMA), takes three to four weeks. This approach is based on the control and knowledge of experts and scientists at the EMA. This is necessary, because the responsibility is enormous when it comes to injecting a biologically active substance into a healthy person.

The UK has chosen the route of emergency marketing authorizations, we have chosen another, and we believe it is the right one. Israel is also often cited as a model of success. The country is highly digitalized – and that’s good – but personal health data is given to companies there. This is not something we would want to do in the EU.

Shouldn’t we publish contracts with pharmaceutical companies?

U. V. D. L. : The rules are clear: when a contract is signed between us and a private company, both parties must give their consent before publication. We are now discussing with companies, because we believe that more transparency is needed.

→ DEBATE. Should European vaccine manufacturing contracts be made public?

I understand that some data is sensitive and cannot be published, such as the address of a production site. It must be said that there is no public interest in publishing this kind of information either. For the rest, we try to convince companies that it is in their interests, as in ours, to create a climate of trust by making these contracts public.

Have you not given European citizens false hope by promising them vaccines quickly?

U. V. D. L. : Vaccination campaigns in Europe almost all started on December 27. It took enormous effort to get there. But we have certainly underestimated the difficulties we are experiencing. We should have warned, explaining that at first the process would not be smooth, that there would be ups and downs.

In total, this makes around 100 million doses for the first quarter in the EU. In Europe, we aim for 70% of the adult population to be vaccinated before the end of the summer. This is no small feat, we are heading in the right direction. There will certainly be other obstacles, other problems in production, and we must also be prepared for possible shortages of raw materials or certain components of these vaccines.

The Commission tried on Friday January 29 to use Article 16 of the Northern Irish Protocol, which allows certain provisions of Brexit to be overridden, to ensure that the region is not a gateway for vaccines to Great Britain. Brittany. This was seen as a weakening of the peace on the island of Ireland. Is it a regret?

U. V. D. L. : We shouldn’t even have thought about section 16! I regret. The Commission took around 1,500 decisions in a short period of time and almost 900 emergency decisions under very high pressure. I admit it: it’s a never-ending task to communicate with all parties.

→ EXPLANATION. Northern Ireland’s first post-Brexit scramble over vaccines

And whatever the Commission does or decides, I have full responsibility, and I know that I can count on 26 Commissioners, our Vice-Presidents, our Executive Vice-Presidents, and this College has grown together.

Will the Russian Sputnik V vaccine be available in Europe?

U. V. D. L. : We have safe and effective vaccines on the European market. The decision to turn to EMA for possible marketing authorization depends on each company. For us, having the scientific opinion of the EMA is a prerequisite. In particular, we need to know what clinical trials have been conducted. Company data must be transparent. The same is true in the United States with the Food and drug administration (FDA).

→ READ. Covid-19: Russian vaccine Sputnik V is demonized

So, whether it is Russian, Chinese or other vaccines, the only way to get clearance is to look to the EMA and be as transparent as the rest.

You pleaded for a mechanism for sharing European doses with third countries. Is an agreement between the 27 possible to implement this solidarity?

U. V. D. L. : The 27 believe that we must also be concerned about our neighbors. But we are in a difficult situation, which makes progress in this area difficult. We are working on it, we are in contact with the Member States to see if they can give doses. We must not forget the Covax mechanism, for which Europe has invested no less than 870 million euros so that high-income countries can finance the purchase of vaccines for low- and middle-income countries. We must support Covax as much as possible, so that this mechanism works as quickly as possible.

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Three out of six vaccines authorized, two more ordered

The European Commission has signed six contracts with manufacturers of anti-Covid vaccines. Three have been authorized (the German-American BioNTech-Pfizer since the end of December, the American Moderna since January 6, the Swedish-British AstraZeneca since January 29) but they have suffered significant production delays.

By early February, the EU had received 18.5 million doses, including 17.6 million from BioNTech-Pfizer and 854,000 doses from Moderna. The EU expects 100 million doses in the 1st quarter, then 300 million in the 2nd quarter, or 200 million Europeans vaccinated by the end of June.

The American Johnson & Johnson vaccine (up to 400 million doses) could be approved in late February, followed in May by the German CureVac (up to 405 million doses). Sanofi-GSK (up to 300 million doses) is not expected to arrive until the fall. The European executive has just reserved 100 million additional doses of the American Novavax, and 60 million of the Franco-Austrian biotech Valneva.

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