Coronavirus. What will change the approval of the Moderna vaccine in Europe

Soon a new vaccine approved by the European Medicines Agency (EMA)? This Wednesday, the evaluation of the Moderna vaccine against coronavirus resumes, under pressure from EU countries that want to increase the speed of vaccination while the health situation on the old continent deteriorates.

At present, only the Pfizer / BioNTech vaccine is used in the EU, after being approved on 21 December. But what would change the authorization for a new vaccine, the one marketed by Moderna?

The context

In Europe, pollution is rising again while vaccination has started unevenly (and fearfully) in EU member states since the end of December. In the face of the deteriorating health situation, several states, such as Germany, have chosen to reintroduce.

The inertia of the vaccination campaign has been highlighted in France, but also in Germany and the Netherlands. European countries are therefore in a hurry to see the arrival of a new vaccine, which will still make it possible to “strengthen, accelerate and simplify” vaccination, as the Minister of Health Olivier Véran announced on Tuesday morning. And gain collective immunity faster to stop the epidemic.

Modern vs. Pfizer / BioNTech

When it comes to comparisons between vaccines, it is mainly logistically that Moderna has advantages over the competitor Pfizer / BioNTech.

On the technology used. Both vaccines are based on innovative and recent messenger RNA technology. The vaccines from Pfizer and Moderna consist roughly of injecting a piece of RNA which, on the same principle as the regular vaccines, will make the patient’s body believe that it is infected. And pressure the immune system to respond.

On efficiency. Again, the two vaccines are approaching. According to clinical studies, Pfizer / BioNTech is slightly more effective than its competitor: 95% efficiency (and 52% if a single injection). This efficacy is maintained in those over 65 years (94.7%), while age is a crucial factor in severe forms of Covid-19.

The Moderna vaccine has an effect of 94.1% in the two months after the second injection, without any special side effect. It has also been shown to be slightly more effective in older people than in younger people.

In the mode of administration. No notable differences between the two vaccines. It takes two doses, injected at 28-day intervals for Moderna, 21 days for Pfizer / BioNTech, to ensure vaccination coverage.

About logistics. It is at this point that Moderna really wants to make it possible to accelerate and simplify the vaccination campaign. The Pfizer / BioNTech vaccine requires complex logistics. It must be maintained at -70 ° C from the production site. Its transport and storage therefore requires a super-freezer, thermal containers and refrigerated trucks to respect the refrigeration chain from the moment it leaves the factory. Once thawed, the dose can only be stored for five days.

The Moderna vaccine can be stored at -20 ° C, which facilitates transport and storage.

The calendar

If the Moderna vaccine is given the green light this Wednesday by the European Medicines Agency, it must be validated by the European Commission (this was quickly for Pfizer / BioNTech) and then approved in the various Member States according to their national procedure. In France, this will require an opinion from the Technical Committee on Vaccinations of the High Authority for Health (HAS). It will evaluate the vaccine and make recommendations, especially about the public to be vaccinated.

The validation from HAS can intervene quickly towards the end of the week, and paves the way for the administration of the Moderna vaccine from the beginning of next week.

In total, the EU has so far ordered 160 million doses of this vaccine to Member States. France will receive 15%.