The Coronavirus pandemic continues to exert a strong grip on the world. The second wave is now rolling over Europe and, although we are better prepared, it appears at least as challenging as the first. A return to pre-pandemic life will only be possible with a vaccine. There has been promising news in recent weeks; BioNTech-Pfizer, AstraZeneca and Moderna have already published positive and promising Phase 3 data.
These are now being analysed in a rolling review by the European Medicines Agency (EMA), and I hope one to three of these vaccines can be authorised by the end of this year. From what we hear, other parts of the world could go for so-called emergency authorisations, meaning vaccines would be on the market earlier in those countries than here in the EU. This possibility would also exist for each EU Member State, but I believe that the right way is conditional market authorisation for the whole EU, even if this briefly delays market access.
As a conditional marketing authorisation requires higher standards of evidence submitted and necessary checks, we should take this time to ensure greater security and a closer examination. Other promising vaccines are not yet ready, but I am optimistic that CureVac, GSK-Sanofi and J&J will be completed in the first or second quarter of 2021 and hopefully ready to apply for market authorisation.
“The second wave is now rolling over Europe and, although we are better prepared, it appears at least as challenging as the first”
The European Commission, in cooperation with the German Presidency, has already conducted intensive negotiations in the summer with the various companies, even before it was even possible to foresee how this research would progress.
Talks have been held and contracts concluded with the current most promising producers - BioNTech/Pfizer, AstraZeneca and Moderna - enabling us to obtain 860 million vaccine doses for the citizens of the European Union next year, 400 million doses from AstraZeneca, 300 million from BioNTech/Pfizer and 160 million from Moderna.
Assuming EMA authorisation, we can thus vaccinate 430 million Europeans (two doses are needed per person). This means that almost every EU citizen would have an opportunity to get vaccinated, something we would not have believed possible. The Commission has also concluded contracts with the manufacturers Curevac, J&J and Sanofi /GSK.
If all projects are successful, we will have a surplus, but this is not a problem, as the contracts explicitly state that we can also give the vaccine to third countries, for example in the Western Balkans or Africa. If projects fail or are delayed, other vaccines would still be available. Of course, just like other medicines and vaccines, these must be meticulously tested by the EMA; only then can and will a marketing authorisation be granted.
All vaccines authorised by EMA in Europe are safe, and this must - and will - be the case with Coronavirus vaccines. However, the Commission’s strategy, together with the German Council Presidency, was spot on in concluding contracts with various manufacturers at an early stage, even if the prospects of success were unclear at the time. The fact that taxpayer’s money was used to create, for example, production facilities in order to be able to produce on a large scale was essential to allow taxpayers to benefit quickly from the vaccines.
The costs that are and have been necessary are far below those that would be incurred were the pandemic to continue. One thing is clear: a vaccine will not end the Coronavirus pandemic overnight. It will take many months before the necessary 60-70 percent of people in Europe are vaccinated following authorisation.
“The Commission’s strategy, together with the German Council Presidency, was spot on in concluding contracts with various manufacturers at an early stage”
However, if we vaccinate risk groups and medical staff first, as planned, as early as March it will be possible to give them such a high level of protection that the pandemic will lose its fear factor, as far fewer infected people will also have a serious course of disease. Until then, we need to hold out for the coming weeks and months to prevent a further increase in the death toll as far as possible.
Finally, yet importantly, I would like to conclude by clearly expressing my confidence in our European authorisation authority. If a vaccine is authorised in Europe, I will of course also try to be vaccinated, and I will do so as soon as the rules of my country allow. For all I know, I am not in the risk group, so I will certainly not be vaccinated first.
However, that will change when working as a doctor, which I plan to do to in order to support the vaccinations, and when it is the turn of medical staff to vaccinate. I recommend the same approach to my family members, young and old.