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northoch, the planned Covid-19 vaccine from Mainz biotech company Biontech is in the middle of the third phase of clinical testing and has yet to overcome the crucial hurdle before approval. However, the company is already preparing for the time when it will be a matter of making the new vaccine widely available as quickly as possible in the fight against the pandemic.
Therefore, Biontech has now agreed to purchase a production facility in Marburg, Hesse, with the Swiss pharmaceutical company Novartis, which will significantly expand the Mainz-based company’s manufacturing capabilities. The place has a long tradition: When Emil von Behring received the Nobel Prize in Medicine in 1901 for his diphtheria and tetanus vaccines, he invested the prize money in building a pharmaceutical factory. The risky strategy paid off in the long run: The Behring factories that he created three years later are still producing vaccines, among other things.
In the future, Biontech’s BNT162b2 could add an entirely new category of vaccines: the so-called mRNA vaccine, in which some of the genetic information from the coronavirus is funneled into the cells of the human body. Biontech, together with CureVac and American Moderna based in Tübingen, is one of the main developers of this new technology.
“Of all the places where von Behring manufactured his serums for millions of people back then, now there is the possibility of making the vaccine that the world urgently needs,” Biontech chief Ugur Sahin said at a called press conference. on short notice, with a bust of Behrings alongside. themselves. “We see that as a very good coincidence.”
Marburg as one of mRNa’s most important production facilities
The Mainz team’s plans are as ambitious as those of the historic model. If the results of the ongoing phase three study are positive, the marketing authorization for the new vaccine must be applied for in October. “We are working on a parallel approval strategy with both authorities,” Sahin said, referring to the responsible drug regulatory agency FDA in the US and EMA in Europe.
Recently, the company announced that it would increase the number of test subjects from 29,000 to around 44,000 to gain even more insight into the potential vaccine’s effectiveness and side effects, including in patients with HIV or hepatitis C.
If approved, things should go fast: Biontech and its US partner Pfizer want to produce up to 100 million units of their own vaccine worldwide by the end of 2020. By the end of 2021, it should be around 1.3 billion.
With the new production facility in Marburg, there is possibly even more: according to plans, existing vaccine capacities will be expanded to 750 million doses per year or more than 60 million doses per month and the Marburg location is “one of the largest mRNa production sites in Europe Biontech CFO Sierk Poetting announced.
Unorthodox approach
So far, there is not a single vaccine approved worldwide that is based on this new type of technology. The head of Biontech, Sahin, made it clear that there is experience with mRNA technology. This has been researched for more than 20 years.
Previous tests with test persons had shown that the side effects of this vaccine were mild to moderate. “A good vaccine should have an immunizing effect of at least 70 to 75 percent, and that is the benchmark that we have set for a vaccine that can significantly stop the pandemic,” Sahin said.
As fast as Biontech, only Moderna and the British-Swedish company Astra Zeneca are currently in the race for a vaccine among Western companies, and they also want to complete their ongoing phase three studies in October or November. However, Astra Zeneca had temporarily suspended its own study last week after serious side effects occurred in one subject.
It is unusual that the industry is already massively increasing its production capacities, although none of the candidate vaccines have yet been approved. Businesses often wait for this crucial hurdle to pass before taking big chances. But amid the pandemic, manufacturers and governments want to make sure potential vaccines can be distributed worldwide immediately as soon as regulatory authorities give the green light for approval.
Both the US and the EU Commission are multitrack
The risky strategy is only possible because several states have agreed in advance to purchase a certain amount of their vaccine doses from manufacturers if approval is successful and to financially support the companies in their efforts.
The United States, where the search for a vaccine has long become a campaign issue, has been particularly active in this regard: So far, the United States government has ordered about 800 million doses of vaccine to six from major Western vaccine developers and has also had the option of 1.4 billion more Have Insured Units.
The EU Commission has signed a contract with the British-Swedish Astra Zeneca and has entered into potential supply agreements with five other companies, including Pfizer and Biontech.
When asked, the company would not say what price Biontech would have to pay in order to take over the traditional plant in Marburg from Novartis. The Swiss group also did not provide information. If the authorities agree, the transaction is expected to close in the fourth quarter of 2020.
The 300 employees employed at the plant will be taken over. So far, Biontech has manufactured its own candidate vaccine at its production facilities in Mainz and Idar-Oberstein, while Pfizer has four production facilities in the US.
According to the World Health Organization, WHO, there are around 180 Covid-19 vaccine projects around the world, 36 of which are already in human clinical trials. The rapid progress made by researchers recently led US President Donald Trump to claim that a Covid-19 vaccine could be used widely starting in October. Leading vaccine experts, including the U.S. disease protection agency CDC, don’t expect such a vaccine until spring 2021 at the earliest.
