Corona vaccine: a ray of hope and many questions

Like the first Western manufacturers, Biontech and Pfizer published the results of a study that was crucial for its approval on Monday. Consequently, its vaccine offers more than 90 percent protection against Covid-19 disease. No serious side effects have yet been reported, he said. The companies expected to apply for US FDA approval starting next week.

Biontech had been developing the BNT162b2 vaccine in the “Lightspeed” project since mid-January. The phase 3 study, which is crucial for its approval, began in late July. By Monday, more than 43,500 people had received at least one of the two vaccines, which are administered every three weeks. According to the manufacturer, protection by vaccination is achieved one week after the second injection.

The Biontech preparation is a so-called RNA vaccine that is based on a completely new mechanism. It contains genetic information about the pathogen, from which the body produces a viral protein, in this case the surface protein with which the virus enters cells. The goal of vaccination is to stimulate the body to produce antibodies against this protein to intercept viruses before they enter cells and multiply.

Yes. However, this information so far is only based on a short notification from the manufacturer. Therefore, virologists remain cautious in their evaluation. “I hope that the data will be released as soon as possible so that a more accurate picture can be obtained,” said Stephan Becker, director of the Institute of Virology at the University of Marburg, the German Press Agency. Overall, however, he speaks of “a very positive result.”

Clemens Wendtner from Munich Clinic Schwabing was also surprised by the high effectiveness, which Biontech and Pfizer claim with more than 90 percent. “This is remarkable as many ongoing vaccination studies on Covid-19 currently only require a success rate of at least 50 percent.” The US FDA had also set a 50 percent effectiveness as the minimum value for possible approval.

If the high efficacy of more than 90 percent is confirmed, “this would be an unexpectedly high vaccination efficacy,” says Leif-Erik Sander, director of the Vaccine and Infection Immunology Research Group at the Berlin Charité. Many routine vaccines, such as flu vaccines, did not reach such high levels. “This is even more astonishing given that no vaccine with mRNA technology has ever been approved.”

Little so far. According to the company, there have been no safety-relevant side effects so far. The virologist from Charité Sander points out, however, “that the period of observation of the relevant side effects of the vaccine is still too short”.

It is not clear whether the vaccine is equally effective in different groups, especially risk groups such as the elderly. Older people probably need higher amounts of vaccine due to their weaker immune systems, adds Sebastian Ulbert, Head of Immunology at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig.

Virologist Sander also loses information on how much the vaccine protects against severe courses of Covid-19. “In addition, you have to show how long the protection of vaccination lasts.” The head of Biontech, Ugur Sahin, assumes that vaccination can achieve an immunization effect of one year. But this is not yet certain. Protection against Covid 19 infection of more than 90 percent announced in the interim analysis was achieved 28 days after the start of vaccination treatment.

The companies Biontech and Pfizer want to submit an application soon for the approval of a corona vaccine in the US They anticipated the application for full emergency approval of the vaccine for people aged 16 to 85 years in the US To do this , the companies must have collected safety data from about half of the roughly 44,000 study participants over two months. This goal will be reached next week.

Biontech and Pfizer, which are already working together to develop mRNA-based flu vaccines, currently estimate that up to 50 million doses of the coronavirus vaccine will be produced worldwide this year. That would be enough to vaccinate 25 million people. Up to 1.3 billion cans will be produced in 2021.

Under the supply agreement with the US, the price of a two-dose vaccine treatment is expected to be $ 39. Other industrialized countries should not receive a lower price than the United States, he said in July.

During the pandemic, there is an accelerated approval procedure in Europe with the European Medicines Agency (EMA). If vaccine approvals sometimes take years, drug companies can now report their vaccine candidates to the EMA in a sort of preliminary approval procedure during the clinical studies phase. To this end, the EMA (Continuous Review Process) continuously submits and assesses the data. For now, in addition to Biontech, the British-Swedish company Astrazeneca is also taking this route.

However, this procedure does not mean that less data should be presented, the president of the ethics council, Alena Buyx, stressed on Monday. There will be no provisional approval in Europe. After EMA experts have read and rated thousands of pages of results from all prescribed clinical phases, they give their recommendation to the European Commission. Decide whether to grant admission. In the positive case, it grants approval for all EU member states. Many experts expect the first approvals for this year or early 2021.

Speed ​​shouldn’t be at the expense of thoroughness, says the German Paul Ehrlich Institute (PEI), which approves drugs nationally. Because vaccines can have side effects or cause harm if they are not thoroughly tested and evaluated.

To be supplied with the coveted product at an early stage, the EU and other countries are already signing supply contracts with pharmaceutical companies. So far, the EU Commission has signed framework agreements with the pharmaceutical companies Johnson & Johnson, Astrazeneca and Sanofi-GSK. Such a contract is still being negotiated with Biontech / Pfizer, a commission spokesman said Monday.

Health Minister Jens Spahn increased the pressure on ZDF: he wanted the EU to reach an agreement with Biontech and Pfizer “in the next few days”. “As German Health Minister, it would be difficult for me to explain if a vaccine produced in Germany was vaccinated more quickly in other regions of the world than in Germany itself,” Spahn stressed. That is why the federal government is pressuring the EU Commission “to have the contract signed now quickly.”

But even if Biontech goes into production before approval: the company is far from being able to cover these large quantities required, at least initially.

In a thesis work, Matthias Schrappe, an internist at the University of Cologne, assumes that it would take around a thousand working days, that is, four years, to vaccinate some 60 million people in Germany. And only if 60,000 vaccines can be administered per day. Therefore, daily capacities must be increased.

In early November, the federal and state governments agreed that the federal government would purchase and finance the vaccines. The federal states take care of the necessary accessories and establish vaccination centers independently. Currently a total of up to 60 locations is assumed. As soon as it is available, the vaccine will be delivered to these places by the Bundeswehr or by the companies themselves.

Vaccine here – Missing crown? That won’t work, at least not quickly. “The vaccine will help us get out of the pandemic,” said Swiss virologist Isabella Eckerle on the transmission of ARD. Difficult but fair. However, there will be a long transitional phase in which the protective measures against the corona must be maintained. “You shouldn’t imagine that the vaccine will arrive and that from tomorrow we can go back to our previous lives,” said Eckerle, who heads the Center for Emerging Viral Diseases at the University of Geneva.

Karl Lauterbach, a health expert with the SPD, also reduced the exaggerated expectations. It would take at least a year for all of Germany to be vaccinated up to “herd immunity”. Only then can one speak of dispensing with the mask and distance. The next few months will be very difficult: 2021 will essentially be another year of restrictions.

The president of the World Medical Association, Frank Ulrich Montgomery, evaluated the positive results of the vaccine as a “great success”. But it is not a breakthrough yet. “The study has not been evaluated to the end,” he told the “Passauer Neue Presse.” Hopes are growing that they will have a vaccine for the foreseeable future. But if the request for approval is made in November, that does not mean that the request will be approved in December.

The Mainz-based company employs about 1,300 people, making it a comparatively small player in the pharmaceutical business. According to the commercial editor of NDR information Biontech has yet to launch a single product in its twelve year business history. Biontech is led by Ugur Sahin, who founded Biontech in 2008 together with his wife Özlem Türeci. Sahin is the CEO and his wife is in charge of clinical development.

The company address “An der Goldgrube 12” is symbolic: Biontech cannot complain about the lack of interest from donors. The company has raised about $ 1.5 billion from investors in recent years. The main donors include the Strüngmann brothers, founders of the Hexal generic group. Microsoft founder Bill Gates is also pumping millions into Biontech through his foundation. Partners include pharmaceutical giants such as Sanofi, Eli Lilly, the Roche subsidiary Genentech, and Pfizer.

Success can also be seen in Biontech’s share price: in the US IPO of September 2019, the papers were issued for $ 15, now they cost more than $ 90. That catapulted Sahin to the list of the 100 richest Germans. “Die Welt am Sonntag” takes him, together with his wife, who is also on the board, to position 93 with a net worth of 2.4 billion euros.

Pharmaceutical companies and scientific institutions around the world are researching vaccines against the coronavirus. Several German applicants are also there. Read who is here: