Moderna vaccine 'to start production in Spain next month'

A VACCINE against Covid-19 developed in Spain will be ready for production to start 'in less than a month', according to laboratory Rovi.

Its deputy chairman and finance manager Javier López Belmonte says the inoculation created for the pharmaceutical giant Moderna – based in the USA – will be at least partially manufactured in Spain, where it was devised, and that its promising results mean this could begin as early as mid-December.

López Belmonte says Rovi has struck a ground-breaking deal with Moderna allowing it to produce the vaccine for 'all the markets outside the USA', which include Europe, Asia, and all of the American continent apart from the United States itself.

The 'bio-technological part' of the vaccination, or the primary material, is developed by the Swiss company Lonza, then sent to the laboratories at Rovi, which turns it into the final pharmaceutical product, including bottling and packaging.

According to current timescales, the Moderna vaccine could be hitting the market by the beginning of 2021.

Before all this starts, the regulatory process needs to be completed and the drug rubber-stamped.

Moderna will arrange for samples of the product to be sent to the European Medicines Agency (EMA) for approval, and López Belmonte says Rovi expects this authorisation process to be 'very quick'.

“These procedures can take up to a year and a half, but in this case, it'll be done in months,” he explains.

The Moderna vaccine will begin its manufacturing process in the USA first, which means it is likely to be administered across the pond before the end of the year, but once Spain starts with the European, Asian and rest-of-Americas production, the procedure is 'very fast', López Belmonte assures.

“It's basically an injectable solution in an aseptic vial, so the process involves testing to make sure the product is sterile. This part of the manufacturing only takes a few days, and then the process of releasing and checking the sterility of the produce takes 15 to 20 days. In other words, in about a month, give or take, it'll be ready.”

The Rovi production centre is based in San Sebastián de los Reyes, in the Greater Madrid region, but other branches of the company will also be providing manufacturing support work.

All this has required an express revamp of Rovi's premises and facilities, including technology transfer and freeing up additional funds for investment.

Unlike the Pfizer vaccine – which looks set to be the first in the 'race' and was developed for the German company by a husband-and-wife team, who are both the children of Turkish migrants in the central European country – the Moderna inoculation does not have to be stored at exceptionally-low temperatures.

One of the drawbacks of the Pfizer drug is that it needs to be frozen at around -80ºC, and not all countries on earth will have the facilities to do so.

López Belmonte says the Moderna vaccine can be kept for up to 30 days at between 2ºC and 8ºC – about the same temperature as a household fridge – and up to 12 hours at room temperature, and for longer-term storage, can be kept for six months at -20ºC, which is more feasible for nations with more basic infrastructure.

Additionally, in contrast to other vaccines which come in powder format and need to be mixed with a separate saline solution, the Moderna drug is a single, complete solution with the syringe and needle already attached and can 'just be plunged in' once the packet is opened.

López Belmonte says the Moderna-Rovi deal is one the company, and Spain, are 'very proud' of, since it means the country will have a key rôle in helping society get back to a normal way of life after what is now nearly a year of restrictions, confinements, economic turndown, and families and friends kept apart.

Although the Pfizer vaccine is said to be 90% effective against the SARS-CoV-2 virus, the Moderna version has reported an efficiency level of 94.5% - but it is expected that both will be of a similar effectiveness as they use the same technology, known as 'RNA messenger' systems.

No vaccine can ever be declared 100% effective, even if clinical trials do, in fact, produce 100% protection for all participants.

In the case of the Moderna jab, 95 of the 30,000 volunteers became infected with the SARS-CoV-2 virus, although 90 of them were on the group that had received a placebo instead of the genuine vaccine.

None of these, including the five who had the 'proper' jab and became infected, suffered any serious effects from the virus, which may show that even though the vaccine had not protected them entirely, it had dramatically reduced the viral load, or boosted their immune system, or both.

The clinical trials for the Moderna vaccine included 7,000 volunteers aged over 65 and 5,000 aged under 18, all with chronic health conditions that would make them even higher-risk patients if they caught Covid-19, such as diabetes, severe obesity and heart problems.

Once the Moderna inoculation has been approved by the USA's Food and Drug Agency (FDA), a total of 20 million doses will be manufactured for the North American country, then the EMA authorisation will allow for 160 million out of the one billion remaining doses for the rest of the world to be distributed.

The European Commission has also signed a deal with Pfizer to buy 300 million doses.

Moderna laboratories' technical director Juan Andrés said on Spanish TV channel Antena 3 that he expected the vaccine to reach Spain by the beginning of 2021, when it would firstly be administered to high-risk members of the public – the over-65s, those with physical health problems, and medical and care staff.

Costs are likely to be higher than expected – both the Pfizer and the Moderna vaccines need an initial dose and then a booster, but the amount administered with the latter, 100 micrograms, is over three times the 30 micrograms needed with the Pfizer drug, meaning the Moderna jab will cost around €30 to €40 per person and the Pfizer vaccine about €25.

The exact retail price has not yet been set, since both could be under pressure to try to match the token prices promised by other laboratories – AstraZeneca, which is behind the 'Oxford vaccine', is expecting to sell the final product at just over €3 per person, and Johnson & Johnson is looking at a price tag of about €9.

As a result of the imminent nature of the vaccine production, Moderna's shares have soared by around 200% in the past week.