The end of the clinical trials of the most advanced Covid-19 vaccine projects on the planet is approaching and the European Union (EU) is finalizing negotiations to ensure access to the first available.
César Hernández, head of the Department of Medicines for Human Use of the Spanish Agency for Medicines and Health Products (AEMPS), is part of the negotiating team of the European Commission.
Is there a lot of international competition to buy these first vaccines?
Yes, but the EU is the largest market in the world and there is an interest on the part of all. Furthermore, the EU has committed itself to ensuring that, from here, vaccines reach places where they normally would not: throughout Europe and in high, middle and low income countries around the world.
We are all aware that this is not a national problem, it is a global problem and no one will be safe until everyone is safe.
What criteria does the EU follow to choose between the different projects that are underway?
Right now, what you are looking for is to have a wide portfolio of vaccines. We do not know which vaccines will end up having authorization or if all the vaccines will succeed or if they will have production problems. For all this, we work on a wide portfolio that includes several platforms.
What projects are they?
We are negotiating with two groups. Right now, there are closed contracts with AstraZeneca / University of Oxford, Sanofi / GSK and Johnson & Johnson and negotiations continue with Pfizer / BionTech, Novavax, Moderna and Curevac.
That is the first group and then negotiations continue with other companies whose vaccines will arrive later.
If that first group worked, would there be enough to vaccinate the entire population?
If all of them work, indeed, there are a number of doses that I would give to vaccinate the entire European population and more. In that case, the second group may not be necessary or it may not be necessary for the general population, but it may be necessary for those over 80 years of age, for example.
How many doses will be necessary per person?
We know that almost all vaccines are given in two doses, but we do not know if additional doses will be necessary. Maybe there are vaccines that require every few months to be reinforced with a booster.
The AstraZeneca vaccine and the University of Oxford is supposedly the most advanced, is it still confident that it will be available this year?
It is very difficult to talk about dates although we understand the interest. Now all clinical trials are waiting for a sufficient number of cases to be positive.
When that number is reached, the data will be published and we will see. We can find vaccines that seem to be coming very soon, but that can be delayed and the opposite, others that seem to be slow and can be advanced.
All seven of the first group with which we are negotiating will be distributed from December of this year, according to AstraZeneca’s plans, until the middle of next year, in the case of Sanofi.
With AstraZeneca a clause was signed that made states jointly responsible for possible side effects.
It is one thing that, in a situation like the one we are experiencing in a pandemic and with prices that are far from commercial, all companies put it ahead.
What European legislation says is that someone who puts something on the market, whatever it is, has to be responsible for what happens with it. That doesn’t change at all. A company is responsible for the effects that the vaccine produces.
What has been agreed is that if there were any side effects that could not have been found in the trials due to their very low frequency, the responsibility would fall on the company, but there would have to be a solidarity compensation from the states.
This is generating a certain fear in some part of society.
The risk of side effects always exists. Any vaccine that has a safety problem is not going to be licensed. What remains are those things that could arise and that no one could have foreseen would happen. This happens with all vaccines.
What happens if there is not a sufficient percentage of the population willing to be vaccinated?
You have to work to avoid it and for people to understand it. I believe that, if there is an effective vaccine and a percentage of the population is vaccinated and can begin to lead a normal life, the rest of the people will not take long to think that this is something worthwhile.
There is a false belief that we are going to have licensed vaccinations out the back door and this is not going to happen. It is true that many atrocities are heard even from well-informed people, such as that the first vaccines are not going to be good. The first vaccines, if they are bad, will not be authorized.