This is how the Spanish Rovi will manufacture the Moderna vaccine for Europe

Updated: Tuesday, November 17, 2020 2:42 PM

Published on: 11.17.2020 13:02

It is one of the most promising vaccines in the race which is disputed to have a vial against the coronavirus and which will be manufactured in its final phase in Madrid. Rovi’s lab will be responsible for creating millions of doses of the Moderna vaccine for markets outside the United States. Thus, Europe, Asia, part of America and Canada will receive these vials. But how is this Spanish company preparing for this great challenge? What are the deadlines and the keys to the manufacturing process? We give you all the details.

Manufacturing and deadlines

The deal isn’t new, but the challenge this veteran company faces is. The Spanish company already signed with Moderna in July for the large-scale manufacture of its mRNA-1273 vaccine against the coronavirus and Rovi has been preparing for it ever since. The laboratory will receive the biotechnological part of the vaccine developed in Switzerland and from this product, it will manufacture and package the vials of the finished product.

Millions of doses for which it was necessary to create a new production line and equipment for formulation, filling, automatic visual inspection and labeling.

As Javier López Belmonte, vice president and chief financial officer of Rovi, explains in an interview at “ 20 minutes ”, although the news jumped on Monday with Moderna’s announcement on the effectiveness of the vaccine, close by 95%, the antigen can be start to pack from the beginning of 2021. All according to the deadlines already planned.

Technology transfer, one of the keys

In the production of Moderna vaccine, a series of engineering steps must be followed before embarking on “routine” manufacturing, from knowing the manufacturing process itself to mastering it. After validating, these batches are then sent to the regulator. From there, it is the regulator which gives the green light (or not) to be able to start manufacturing. An already advanced process will be faster than usual, probably the European Medicines Agency will approve it in a few months.

How long will it take to produce the vaccine?

Once “routine” manufacturing has been approved, the process is “more or less rapid”. Rovi will create an injectable made in aseptic filling. In other words, with an analysis which confirms that the product is sterile. A first process that only takes a few days and a verification process that takes 15 or 20 more days. “In about a month, it would be ready,” López Belmonte said.

Warehousing and distribution

Moderna’s vaccine will be easier to store and distribute than Pfizer’s (which requires temperatures of 80 degrees below zero), although in any case Moderna itself will take care of these tasks.

Moderna vaccine can be stored for 30 days at a refrigerated temperature, between 2 and 8 degrees Celsius. It can be frozen for six months at -20 degrees Celsius, the usual freezer temperature, and it can last 12 hours at room temperature. In addition, unlike other vaccines, it does not require dilution and is administered directly.

Europe is still negotiating the purchase of Moderna’s vaccine

The agreement is not yet concluded. The European Commission signed a preliminary agreement in August to acquire Moderna’s vaccine, more precisely 80 million doses, of which 8 million would correspond to Spain (10%). “We don’t know which vaccine will end up being safe and effective. The European Medicines Agency will authorize them after conducting a solid analysis, so we need to have a large portfolio of vaccines based on different technologies,” the president explained. Von der Leyen.

So far, five agreements are already in place for the procurement of the vaccine by the EC. The last this Monday with the German pharmaceutical CureVac (400 million doses), to which are added the agreements with AstraZeneca, Sanofi / GSK, Johnson & Johnson and Pfizer / BioNTech. The first three are already signed, while the fourth has not yet been signed by both parties.

Spain would be entitled to 10% of the doses, or 20 million Pfizer, 30 million Astrazeneca, 30 million Sanofi / GSK, 20 million Johnson & Johnson and 40.5 million CureVac.

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