Corona vaccine: can licensing be expedited?

AThe EU-wide coronavirus vaccination campaign started on Sunday. Organization and logistics are in place, but very few vaccines are still available. There are already signs that it will take a long time to vaccinate large sections of the population, in Germany and much 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, vaccines for five million people.

Now the state is going to force manufacturers like BioNTech to transfer the license to produce vaccines to other companies so that capacity can be increased rapidly, at least in this country, this is what parts of the Die Linke party demand.

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

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

BioNTech has acquired a production plant in Marburg from the Swiss pharmaceutical giant Novartis. “The goal is to make production possible there in February or March. And that would greatly increase the amount, ”Spahn said.

How does the license work?

From a purely economic point of view, companies initially have a limited interest in licensing. Laboratories around the world have been hard at work developing corona vaccines for months, vaccines have never been developed faster. The euphoria could be observed in the stock market in recent months. At times, the value of a BioNTech share exceeded 100 euros; in December 2019 it was around 30 euros.

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

On the other hand: the German state has been very involved in the development. BioNTech alone received 375 million euros, ultimately taxed. And the company and its partner Pfizer are reported to charge nearly € 17 per dose, which the federal government also pays as a buyer.

That is why BioNTech is now required to be generously compensated, but that production is possible in various locations. In any case, companies like BioNTech should benefit from this: there are no serious figures on a possible license grant. In view of the tense situation, manufacturers like BioNTech are likely to be rewarded like a prince for passing them on.

Licenses move faster?

That must be assumed. Germany is home to many large pharmaceutical companies, medium-sized companies with technical knowledge and well-equipped laboratories. If some of them used their free capacities or created new ones, the production of the cans could increase rapidly many times, at least in theory.

Because vaccine production is complex. Even with a license issued, growers cannot produce large quantities overnight. Also, resources are limited and in the case of the BioNTech vaccine, third-party intermediary companies have to clean up the ingredients.

For this, contracts should also be concluded; There is also the demanding cold chain, which cannot be climbed arbitrarily high. “Vaccine production is very demanding, you can’t just do it with another licensed company,” says Spahn.

However, logistically, much larger quantities of vaccine could already be administered. A large portion of the nearly 400 vaccination centers nationwide is ready for use, but very high utilization is not expected in the coming weeks due to limited dose availability. In addition, mobile vaccination teams are currently in operation, mainly vaccinating residents and employees in homes for the elderly and elderly.

What are licenses in the pharmaceutical industry about?

It is common for companies to enter into manufacturing partnerships and agreements. Small labs working on promising developments often partner with larger corporations. The cooperation between BioNTech and Pfizer is one such example: the Covid-19 vaccine was largely developed in Mainz; Without the US pharmaceutical giant Pfizer, global distribution and production of 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.

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

If, on the other hand, another company obtained the license to manufacture vaccines, the vaccine could still be run under the BioNTech label; those details would depend on the contractual agreement.

What licensing agreements exist for vaccines?

Not all companies that have investigated a vaccine make it themselves. In the case of BioNTech, Pfizer took over not only the organization of the large-scale clinical studies of the so-called phase 3, but also the actual production and commercialization. Moderna takes a different approach: the American biotech company took over the research and commissioned production from the Swiss pharmaceutical manufacturer Lonza; the vaccine is marketed under the Moderna brand.

But one industry expert comments: “Just because the bottle says Pfizer or Moderna does not necessarily mean that the vaccine was also manufactured in the respective factory. Pfizer has also worked with so-called contract manufacturers. “

Currently, the bottleneck in production is not so much in producing the drugs yourself; this is relatively easy to do in large quantities with an mRNA vaccine. Rather, there is a lack of surrounding areas, such as clean room capacity for proper packaging, vials, caps, and containers.

Who gets the licenses and how much do they cost?

Both are unclear so far. Although the sudden demands for licenses from all parties drag 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 American manufacturer Moderna, whose approval is expected in January. The second German vaccine from Tübingen-based company CureVac could also receive approval in the coming months.

Does licensing promote vaccine nationalism?

For months it has been criticized that “vaccine nationalism” is causing increasing injustice around the world. This is another reason why Germany did not want to go alone with the vaccine, as Jens Spahn said, but rather an EU-wide procedure. If the licenses were granted to German companies, it can be assumed that they would also mainly be sold to the German state. Critics complain that this would cause other states to lag further behind.

A small group of wealthy countries, representing 13 percent of the world’s population, have already secured more than half of their future leading vaccine supplies, writes the charity Oxfam. Specifically, there are already more than five billion cans purchased or insured by contract. According to a recent study by Duke University, less than 800 million doses are destined for the poorest countries in the world.

Development Minister Gerd Müller (CSU) also accuses the United States 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 to just contain Corona in Europe. Otherwise, the virus will return on the next plane, perhaps even more dangerous. “

However, from a global perspective, the BioNTech vaccine does not always play the most important role. Millions of Americans, Israelis and the British have already been vaccinated with the vaccine developed in Mainz. However, much of the world gets vaccines from other countries. Therefore, Oxfam and Duke University’s calculations should be treated with caution.

Only the Chinese manufacturer Sinovac 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.