SPAIN could be key in manufacturing a Covid-19 vaccine from the beginning of next year thanks to a ground-breaking agreement with a US laboratory which is near the head of the race to develop an inoculation against the disease.
One of the Mediterranean country's largest pharmaceutical groups, Rovi, has just reached a deal with Moderna laboratories in the United States to manufacture the vaccine, and one which could put Spain in an advantageous position in terms of future international negotiation.
Deputy chairman and finance manager of Rovi, Javier López-Belmonte – the third generation of the family which founded the pharma giant in 1945, says the company has 'decades of experience' in producing vaccines developed in global laboratories and has thanked Spain's ministry of health for assisting it in finding contacts among researchers working on the drug that could change the planet's life.
“We realised that if we were going to choose a candidate, it was better that it was one of the leaders in the race – and at the moment, without a doubt, this is Moderna,” says López-Belmonte.
The laboratory is one of around 20 or so now at the clinical trials stage and, once a vaccine has been found effective, safe, and then signed off by international authorities, the creators will be in charge of distribution.
Even though the vaccine will be mass-produced in Spain – if the Moderna project is successful – the Spanish government will still need to reach a deal of its own with the laboratory in order to gain access to it, but the fact that one of the country's largest medicines manufacturers is set to be, at least at present, the sole creator, means these negotiations are likely to be much quicker and simpler, López-Belmonte explains.
“That's clear, because the logistical side of it will be much easier in terms of distribution,” he says.
The main manufacturing centre is Rovi's 'injectables' plant in San Sebastián de los Reyes (Greater Madrid region), but the firm's other branches will be 'working on various different stages of analysis', says the deputy chairman.
As a result of the Moderna deal, Rovi has had to double its production capacity so it can set aside an area dedicated 100% to the Covid-19 vaccine.
López-Belmonte says Moderna starts 'stage III' of the development process – the first two 'stages' being the initial research, then creation – which involves clinical trials and assessment of results, on July 27.
After this, if it proves successful, the drug has to be approved by the regulator – the Food and Drug Agency (FDA) in the USA first, then the European Medicines Agency (EMA).
Work on mass production can start even ahead of these sign-offs if Moderna is sufficiently confident that approval is imminent – although initially, before the FDA and EMA signatures are obtained, manufacturing will focus on the active ingredient rather than the complete product.
“We could already be starting to deliver the product within a month,” López-Belmonte explains.
“As yet, we don't have any more information than the market in general does, but we believe that by the second half of 2021 at the latest, we'll be in full production process.”
Concerning potential supply problems, López-Belmonte reveals: “I understand that, first of all, they'll go to cohorts of high-risk patients where, I don't think they'll be distributing enormous amounts to countries as a whole but, rather, splitting them out across various countries so they can start vaccinating, beginning with those most at risk. In any case, these are epidemiological criteria, which isn't our speciality; we just manufacture and if, in the end, they all have to go to Germany or Italy, then we'll have to do what our client – which is Moderna – tells us.”
It would seem unlikely, however, that any EU member State would want, or be allowed, to keep the entire haul of vaccines, given that the only way to beat the virus is if everyone highly-susceptible to catching it or passing it on, and everyone who could be among the worst-affected if they caught it, is immunised.
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