The European Union has ordered up to 300 million additional doses of the vaccine from Pfizer / BioNTech, double what had already been negotiated. In addition, this January 6, Brussels validated a ...

Anti-Covid vaccine: "very, very difficult" to assess production capacity

A dose of the vaccine from the American laboratory Moderna, which is authorized in France.

AP - Elise Amendola

Text by: Pauline Gleize Follow

6 min

The European Union has ordered up to 300 million additional doses of the vaccine from Pfizer / BioNTech, double what had already been negotiated.

In addition, this January 6, Brussels validated a second vaccine to fight against Covid-19, the vaccine from the American laboratory Moderna.

In total, the 27 have therefore ordered up to 760 million doses of these authorized vaccines.

After the research race, the production race began.

Frédéric Thomas, Partner in charge of the health and life sciences sectors at KPMG-France, answered our questions.

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RFI: What is the production capacity of these anti-Covid vaccines?

Frédéric Thomas

It is very, very difficult to answer this question

In production, there are always two stages to consider

primary production which concerns the 'Drug substance' or the active principle, even if it is a little different for a vaccine than for a drug

;

then there is the part which consists in putting in pharmaceutical form, in injectable form for example. Of these two capacities, it is the smallest which will be determining.

In addition, often these two productions are not produced by the same actors.

Numbers are thrown away, but they are often theoretical capacities.

For example, we say 'I have a chain capable of bottling X thousand doses'.

But in real life, it will depend on supplies of the active principle, possibly adjuvants.

So there is a strong risk that official capacities will not be reached.

What is the biggest challenge for these anti-Covid vaccines

There are several types of challenges.

The first was overcome, it was to succeed in designing the vaccine effective on severe forms, even if there are still uncertainties.

Afterwards, for the moment everyone thinks that vaccines are interchangeable.

But the most likely is that they are not, that is to say that some will be effective in reducing severe forms, others in reducing contamination, others in a particular category of the disease. population.

So maybe we will find ourselves facing a major challenge which is to give the right vaccine to the right person.

If it is an age criterion, it will be relatively easy, if it is other criteria it will become more complicated. There are big challenges which will be strictly logistical and organizational.

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Covid-19: the Moderna vaccine obtains the approval of the European Union

Can the race to produce anti-Covid vaccines come at the expense of other drugs or vaccines?

Depending on the choices that will be made, one can imagine that vaccines or other products will be put a little under pressure by the fact that everyone will want to produce vaccines at short notice

And the distinction between primary and secondary production still makes sense here.

The capacity for injectable pharmaceutical formulation, for example, exists.

But for now, the lines are partly used for something else, although Delpharm has announced the creation of another line.

Injectable production is less over-capacity than for standard tablets.

On tablets, the global pharmaceutical industry has overcapacity so it could have easily mopped up.

It's more difficult on the injectable.

Does the question of vaccine production capacities in Europe join the problem of fear of shortages of certain drugs at the time of containment in China?

Is there a health sovereignty problem?

It is not exactly the same problem.

Because the problem of drug sovereignty mainly affects the production of active ingredients.

It's a little different in France, but at European and American level, there is little problem of sovereignty at the level of secondary manufacturing, of pharmaceutical form

As the active ingredients of the vaccines authorized to date are produced in Europe or the United States, there will be no real problems related to China and India.

In any case, in the current state of knowledge.

AstraZeneca and the Russian laboratory Galameïa have joined forces to carry out clinical trials combining their two vaccines, Angela Merkel and Vladimir Poutin have, according to the Kremlin, raised the possibility of a joint production of vaccines: is it not surprising being given the competition that there was around these vaccines?

At the state level, the competition over providing and explaining that we were the first to make the vaccine available has passed.

So now, the subject on which the players want to position themselves is no longer the advertisement but the market share.

From now on, everyone is firing on all cylinders to be sure that the vaccine they have as an industrialist or as an industrial State will find their market. All the means are good to find alliances that will work. help improve geographic coverage, for example.

Could certain alliances within the framework of Covid-19 have a lasting impact on the sector

The BigPharma model is a trial marriage model that has existed since the 1990s. This trial marriage is done as follows: "I co-develop a product with a smaller company or I develops it on its own behalf and if it is successful, I end up buying the company. ”The best example is the takeover of Genentech by Roche.

It is true that if, for example, Pfizer and BioNTech achieve a very good performance on their vaccine and that in addition the vaccine model by RNA-messenger becomes a method, say routine, Pfizer will be tempted to buy BioNTech.

And it will be the same for the others according to the successes achieved by the various alliances

Anti-Covid vaccine: "very, very difficult" to assess production capacity

Anti-Covid vaccine: "very, very difficult" to assess production capacity

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