Sputnik V – soon “Made in Germany”?

So far, the Russian vaccine Sputnik V has not been approved in the EU. But it will soon also be produced in Illertissen, Bavaria. However, there are still a few hurdles to overcome before production begins there.

From Peter Allgaier, BR A high fence, barbed wire and a lot of forest – from the road you can see very little of R-Pharm in Illertissen. But the Bavarian state government has high hopes for the company in the Neu-Ulm district. 2.5 million doses of the Sputnik V vaccine is to be supplied by the company with which a preliminary contract has already been concluded, emphasized Bavaria’s Prime Minister Markus Söder last week . He wants to alleviate the vaccine shortage in vaccination centers and doctors’ offices. But when and whether R-Pharm can deliver the promised quantity is open.

It is currently unclear whether R-Pharm can deliver the promised quantities. Image: REUTERS On the one hand, this is due to the vaccine’s approval for Europe. The location in Illertissen provided a corresponding one in February Application to the European Medicines Agency (EMA) in Amsterdam. Their employees traveled to Russia last Monday to visit production sites there. They also toured two clinics where patients were cared for during clinical trials.

Doubt despite study too high effectiveness

The medical journal “The Lancet” Sputnik V certifies a high level of effectiveness , similar to that of the vaccines from BioNTech / Pfizer or Moderna. But there are also doubts. According to the Slovak Medicines Agency the vaccine that was supplied is different from the one that “The Lancet” rated. However, R-Pharm is struggling with other problems in Illertissen. There are no permits from the Neu-Ulm district for the planned expansion of the company. A construction freeze on the site was the result.

The process in Illertissen is to be accelerated

“We can only approve a fire protection concept or an application under immission control law if they are on the table,” says Franz-Clemens Brechtel, the deputy district administrator. In immission control, for example, it is checked what effects a system has on the flora and fauna, but also on air and water quality. A specially established task force and a project manager are now supposed to ensure that the procedures are accelerated and run more smoothly. Illertissen has a long tradition in the manufacture of chemical products. In 1860 Heinrich Mack bought an oil mill and made bath tablets there. In the 1930s, the physician Karl August Forster then built one of the largest beekeeping farms in Europe with more than 100 million animals on the site. A rheumatoid drug called “Forapin” was made from their poison. The bee culture is still visible in the city today, in a specially set up museum in the city’s castle.

R-Pharm took over the location in 2014

The US company Pfizer then took over the site in the 1970s. The company had drugs packaged, but also drugs made with highly effective substances. The company was particularly at the forefront of what is known as “containment”, a process in which employees do not come into contact with the active ingredient. But that could not prevent the loss of jobs. Around 350 people are currently still employed by the company, which was finally taken over by R-Pharm in 2014.

The municipality has great hopes for production

“The vaccine production would be like winning the lottery,” says Jürgen Eisen. He is mayor of Illertissen, a town with around 17,000 inhabitants, many of whom share his opinion. They hope for good jobs and more income for the place. R-Pharm is currently advertising vacancies: Among other things, specialists in biotechnology are being sought. More than 30 million euros are to be invested in the expansion, according to the Russian company in a press release. In addition to Sputnik V, the manufacturer could also produce AstraZeneca in the future. Corresponding plans have been circulating for six months. But much is still in the balance.

Possible start of production unclear

R-Pharm can currently only produce on the so-called pilot plant scale, that is, try out the individual steps in a small test arrangement and, for example, produce samples for customers. It is unclear when the correct production can start. The government of Upper Bavaria announced that R-Pharm has not yet submitted an application to be allowed to manufacture the vaccine. The authority sees the urgency in the face of the pandemic, but emphasizes – like the district office – the rule of law. The basis is that all necessary documents are available and the requirements are met.

Time is running out

R-Pharm in Illertissen, however, is running out of time. There are still too few vaccine doses nationwide. However, the situation could change in just a few months. Because established manufacturers are expanding their production, others such as the US company Novavax or the French manufacturer Sanofi are trying to get approval. In the end, it could be similar to FFP2 masks. At first there was far too little, but now the copies are piling up at the dealers. The vaccine is likely to be needed in many other, especially poorer countries, also because the vaccine is comparatively cheap.