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 source: Der Spiegel November 9th, 2020, 12:59 p.m.

Translation: GoogleTranslate/doxa-louise

Fight against the coronavirus

Mainz vaccine manufacturer gives hope for 90 percent protection

The company Biontech has presented the first results from its phase III study: These look very promising. Approval should be applied for next week.

For the first time, there are interim results from the study phase that is decisive for approval for a corona vaccine that is relevant for Europe. As the Mainz-based pharmaceutical company Biontech announced on Monday , according to this data, its vaccination offers more than 90 percent protection against the disease Covid-19. It also said that Biontech and the pharmaceutical giant Pfizer are expected to apply for approval from the US FDA from next week.

The vaccine BNT162b2 had been developed by Biontech in the "Lightspeed" project since mid-January. The phase III study, which is crucial for approval, began in various countries at the end of July. More than 43,500 people have now received at least one of the two vaccinations, which are given every three weeks. According to the manufacturer, vaccination protection is achieved one week after the second injection.

In the study, a total of 94 cases of the disease were confirmed by Sunday. According to the information, the preliminary results will only be finally evaluated when a total of 164 cases have been reached. In addition, it will be checked to what extent the vaccination not only protects against Covid-19, but also against severe courses of the disease. Overall, both the protective effect and any side effects should be observed over a period of two years.

Data should be discussed worldwide

The first interim analysis is preliminary effectiveness data, so the vaccination effectiveness can still change after a longer observation period of the test persons. The Data Monitoring Committee (DMC) also reported "no serious safety concerns" and recommended that the study continue as planned with the collection of additional safety and effectiveness data. In the meantime, the data will be discussed with other regulatory authorities around the world, including the US FDA and the European Ema. A scientific publication is apparently in preparation.

"These are great and promising data," said Gerd Fätkenheuer, head of infectious diseases, Clinic I for Internal Medicine at the University Clinic in Cologne. "It is unbelievable that in such a short period of time this progress with vaccine development and clinical testing could be achieved within a few months." The results so far on effectiveness and safety are excellent.

No primary data yet

The head of Infectious Diseases at the University Medical Center Hamburg-Eppendorf (UKE), Marylyn Addo, who is herself leading a vaccine study, said: "These are interesting first signals, which are only given in the press release." Primary data are not yet available and a peer-reviewed publication is still pending. "We have to wait for the exact dates to make a final assessment. At the moment there are still few details about the exact dates, for example with regard to different age groups and in which groups the 94 cases occurred."

An accelerated approval process applies to the corona vaccine due to its particular urgency. Pharmaceutical manufacturers can submit individual parts on the quality, safety and effectiveness of a preparation to the European Medicines Agency Ema even before the complete application for approval. In addition to Biontech, the British-Swedish company Astrazeneca started such a rolling review process for its vaccine candidate some time ago. Astrazeneca has not yet released any Phase III data. Nothing can be said about the schedule, a spokeswoman said on Monday.

The Biontech preparation is a so-called RNA vaccine. It contains genetic information about the pathogen, from which the body produces a virus protein - in this case the surface protein that the virus uses to penetrate cells. The aim of vaccination is to stimulate the body to produce antibodies against this protein in order to intercept the viruses before they enter the cells and multiply.

Biontech and Pfizer expect to be able to provide up to 50 million vaccine doses worldwide this year, and next year they expect up to 1.3 billion doses.

Countries like Russia, China and recently Bahrain have released vaccines with restrictions and are already vaccinating parts of the population with them. But how well these vaccinations actually protect and what side effects they can have is currently largely open.

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