Corona vaccine: can licensing be faster?

AThe EU-wide vaccination campaign against the coronavirus started on Sunday. Organization and logistics are in place, but there is still too little vaccine. There are already indications that it will take a long time to vaccinate large sections of the population – in Germany and in large parts of the world anyway. By the end of March, the federal government expects 10 million doses from the manufacturer BioNTech and its US partner Pfizer – that is, vaccinations for five million people.

Now the state is to force manufacturers like BioNTech to pass on the license to produce vaccines to other companies so that capacity can be increased quickly, at least in this country – this is what parts of the party Die Linke are demanding.

FDP leader Christian Lindner, who wants to force a “crisis production”, made a similar move. He demands a transfer for a fee, whereby the license would remain with BioNTech, the company would be rewarded, but third parties could also produce.

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Vaccination against Covid

Federal Health Minister Jens Spahn (CDU) is skeptical: “We are doing everything together with BioNTech-Pfizer that there can be additional production facilities here in Germany, for example in Marburg,” he told ZDF.

BioNTech has taken over a production facility in Marburg from the Swiss pharmaceutical giant Novartis. “The aim is to make production possible there in February or March. And that would increase the amount enormously, ”said Spahn.

How does the licensing work?

From a purely economic point of view, companies initially have a limited interest in licensing. Laboratories around the world have been working at high pressure on the development of corona vaccines for months, vaccines have never been developed faster. The euphoria could be observed on the stock exchange in recent months. At times the value of a BioNTech share was over 100 euros – in December 2019 it was around 30 euros.

The fact that the prescription for the vaccines could now be pushed into the hands of the competition by government coercion should not only meet with little enthusiasm among shareholders.

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A parallel can be observed between Prime Minister Armin Laschet (right), Michael Kretschmer (left) and RKI boss Wieler

On the other hand: The German state has been heavily involved in the development. BioNTech alone received 375 million euros, ultimately tax money. And the company and its partner Pfizer are reportedly charging just under 17 euros per dose – which is also paid for by the federal government as a buyer.

That is why there are now demands that BioNTech should be generously compensated, but that production should be made possible in several places. In any case, companies like BioNTech should benefit from this: There are no reliable figures on a possible license award. In view of the tense situation, manufacturers like BioNTech are likely to be rewarded princely for passing them on.

Are licenses moving faster?

That is to be assumed. Germany is the seat of many large pharmaceutical companies, medium-sized companies with technical know-how and well-equipped laboratories. If some of them were to use their free capacities or create new ones, the production of cans could quickly be increased many times over – at least in theory.

Because the production of vaccines is complex. Even with an issued license, producers cannot produce large quantities overnight. In addition, resources are limited and in the case of the BioNTech vaccine, intermediate third-party companies have to clean the ingredients.

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For this, contracts would also have to be concluded; there is also the demanding cold chain, which cannot be scaled arbitrarily high. “Vaccine production is very demanding, you can’t just do it with a license from another company,” says Spahn.

Logistically, however, much larger quantities of vaccine could already be administered now. A large part of the almost 400 vaccination centers nationwide is ready for use, but a very high level of utilization is not expected in the coming weeks due to the limited availability of doses. In addition, mobile vaccination teams are currently in operation, mainly vaccinating residents and employees in old people’s and nursing homes.

What are licenses in the pharmaceutical industry about?

It is common for companies to enter into manufacturing agreements and partnerships. Small laboratories working on promising developments often team up with larger corporations. The cooperation between BioNTech and Pfizer is such an example: the Covid-19 vaccine was largely developed in Mainz – without the US pharmaceutical giant Pfizer, global distribution and production in the billions would be unthinkable.

Another example of the corona pandemic: the rapid antigen test from the Swiss company Roche, which is now used millions of times in Europe. The test received its marketing approval in April in South Korea.

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It was developed by SD Biosensor, a company south of the capital Seoul. But it wasn’t until September that Roche launched the test in Europe. Only in the small print do buyers find out that the product is not made in Switzerland.

However, if another company were to obtain the license to manufacture vaccines, the vaccine could still run under the BioNTech label – such details would depend on the contractual arrangement.

What license deals are there for vaccines?

Not all companies that have researched a vaccine manufacture it themselves. In the case of BioNTech, Pfizer not only took on the organization of the large-scale clinical studies in phase 3, but also the production itself and the marketing. Moderna takes a different approach: the US biotech company took on the research itself and commissioned the Swiss pharmaceutical manufacturer Lonza with the production – the vaccine is marketed under the brand name Moderna.

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But an industry insider comments: “The fact that the bottle says Pfizer or Moderna doesn’t have to mean that the vaccine was also made in the respective factory. Pfizer has also already worked with so-called contract manufacturers. “

The bottleneck in production is currently less about producing the drugs yourself – this is relatively easy to do in large quantities with an mRNA vaccine. Rather, there is a lack of the surrounding areas, such as clean room capacity for packaging, suitable vials, caps and packaging.

Who gets licenses and what do they cost?

Both are so far unclear. Although the sudden demands for a license to be granted by all parties are dragging on, Jens Spahn’s statements do not yet indicate that a change in production is imminent.

In addition, other candidates are on the way to approval, such as the vaccine from the US manufacturer Moderna, whose approval is expected in January. The second German vaccine from the Tübingen-based company CureVac could also receive approval in the coming months.

How many cans is BioNTech currently planning?

According to the company, it already has a “complex network of production capacities in Europe”.

In addition to the production of the raw material in the company’s own plant in Mainz and the production in Puurs, Belgium, parts of the production also took place at partner companies such as Dermapharm in Saxony-Anhalt and Polymun near Vienna, said a spokeswoman for the German press agency on Monday.

BioNTech boss Uğur Şahin said last week that his company is looking for further partners for production. The company is aiming for the release of the first vaccine produced in Marburg by the end of March – 250 million doses are to be produced in the plant in the first half of 2021.

Does licensing promote vaccine nationalism?

For months there has been criticism that “vaccine nationalism” is causing increased injustice around the world. This is another reason why Germany did not want to go it alone with the vaccine, as Jens Spahn put it, but rather an EU-wide approach. If the licenses were granted to German companies, it can be assumed that they would also sell primarily to the German state. Critics complain that this would result in other states falling even further behind.

A small group of rich countries, representing 13 percent of the world’s population, have already secured more than half of their future supplies of leading vaccines, writes the charity Oxfam. Specifically, there are already more than five billion cans that have been bought or contractually secured. According to a recent study by Duke University, fewer than 800 million doses are intended for the poorest countries in the world.

Development Minister Gerd Müller (CSU) also accuses the USA and Europe of acting selfishly. More must be done to ensure that “doctors, nurses and risk groups are also vaccinated in developing countries,” he told the “Tagesspiegel”: “It is not enough just to contain Corona in Europe. Otherwise the virus will come back on the next plane – maybe even more dangerous. “

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From a global perspective, however, the BioNTech vaccine does not always play the most important role. Millions of Americans, Israelis and British have already been vaccinated with the vaccine developed in Mainz. However, large parts of the world obtain vaccines from other countries. The calculations from Oxfam and Duke University should therefore be treated with caution.

The Chinese manufacturer Sinovac alone supplies densely populated countries such as Brazil, Indonesia and Turkey. Supply contracts with Sinovac and other Chinese manufacturers are planned for many other countries in South America and Asia.

Will vaccinated people get special rights in the future?

No sooner has vaccination started than a threatening two-class society is already being debated. Several politicians speak out against special rights for vaccinated people. But the decision lies with restaurateurs, hoteliers or airlines themselves.

Source: WELT / Jana Wochnik and Isabell Finzel

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