"Authorizing the emergency vaccine is taking a risk that does not seem justified"

César Hernández, head of the Department of Medicines for Human Use of the AEMPS.AEMPS

The authorization granted by the United Kingdom to the first vaccine against covid-19 is not as complete as the one that the European Medicines Agency will give in less than a month, explains César Hernández (Madrid, 1963), head of the Department of Medicines for Human Use of the Spanish Agency for Medicines and Health Products (Aemps).

The expert explains how the two procedures differ and believes that it is not worth speeding up the European authorization, scheduled for the end of December.

Question.

Why has the British agency been faster than the European one, the EMA?

Answer.

Because it authorizes something different, a kind of compassionate use, with different requirements of a full authorization, which is what the rest of European countries propose.

The British and the one that appears to be given by the FDA [the US agency] are emergency use authorizations, not marketing, with lower requirements.

It's like a compassionate but collective use, like what they did initially with hydroxychloroquine or remdesivir.

Q.

In practice, what is the difference?

Does the authorization allow everyone to be vaccinated?

R.

The authorization will be directed to some groups specifically but the most different thing is the quality support of the product.

The English agency has announced that it is going to authorize batch by batch, that is, it will have to give more authorizations, while a full authorization - which is why it takes more time - allows the usual flow of the rest of vaccines and medicines to be followed.

• The European Medicines Agency defends its slower evaluation of the vaccine: "It is the most appropriate mechanism"

• The UK is ahead of the US and the EU and authorizes the use of the Pfizer and BioNTech vaccine

Q.

Does this affect quality?

A.

One of the most important things about vaccines and biological drugs is to ensure that the batches are the same, that when you manufacture them they always have, for example, the same amount of antigen.

And in these very complex molecules, where it is so easy for messenger RNA to degrade, small variations could lead to changes in effects.

Q.

What other differences are there?

R.

In emergency use you still do not have all the data on the medicine, but you do have partial data and since you are in a serious situation, in this case in a pandemic, even lacking data it is worth authorizing.

The legislation that allows it is common to the rest of European countries.

Another difference is that with a marketing authorization the responsibility for the product rests with the company, while with compassionate use these are exempted because it is not an authorized drug but one that is allowed to be distributed due to the pandemic situation and analyzing the risk-benefit.

Q.

Could other European countries give emergency authorization?

R.

I don't think they will because that would break the current harmonization and consensus.

Q.

Why does the EMA prefer to respect its deadlines?

A.

In a situation in which epidemiologically it does not seem that we are going to get worse, to advance vaccination by a week or two there would have to be a very large potential benefit for the risk that is run.

All drug decisions are based on that relationship.

A very large risk can be accepted if you are going to have a profit that exceeds it.

In the same way, with a very small benefit and no risk you can also take it, but with an uncertain benefit, and with two weeks to a full authorization, taking that risk does not seem very justified.

And an authorization granted in the same way as other medicines helps to generate more confidence in people.

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