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For the first time, there are interim results from the study phase that are decisive for the approval of a corona vaccine that is relevant for Europe. These are promising.
The Mainz company Biontech and the pharmaceutical company Pfizer announced Monday that their vaccine offers more than 90 percent protection against Covid-19 disease. There were no serious side effects.
Biontech and pharmaceutical giant Pfizer are expected to apply for approval from the US FDA starting next week. The independent experts were impressed. “To be honest, this is the best news I’ve received since January 10,” said virologist Florian Krammer of the Icahn School of Medicine in New York.
The BNT162b2 vaccine had been developed by Biontech in the “Lighspeed” project since mid-January. The phase 3 study, crucial for its approval, began in several countries in late July.
Meanwhile, more than 43,500 people have 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.
Expert awaits approval soon
In the study, a total of 94 cases of the disease were confirmed as of Sunday. According to the information, the results are only finally evaluated when a total of 164 cases is reached. In addition, it will be checked to what extent vaccination not only protects against Covid-19, but also against severe courses of the disease. In general, both the protective effect and the side effects should be observed over a period of two years.
Infectiologist Gerd Fätkenheuer from the Cologne University Hospital spoke of “excellent and promising data”. “I think this will have a decisive influence on how we deal with the pandemic and I hope that large quantities of the vaccine will be available quickly.”
Bernd Salzberger from the Regensburg University Clinic expected approval soon. However, experts also note that the data initially only comes from a press release and not from a scientific publication. For example, data on the protective effect in certain age groups were lacking.
An expedited approval process is applied to the corona vaccine due to its particular urgency. Manufacturers of pharmaceutical products can submit individual reports on the quality, safety and efficacy of a preparation to the European Medicines Agency (EMA) even before the full application for approval.
Up to 50 million doses of vaccines by the end of the year
In addition to Biontech, the British-Swedish company Astrazeneca started a continuous review process for its candidate vaccine some time ago. Astrazeneca has not released any Phase III data yet. Nothing can be said about the schedule, a spokeswoman said 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 goal of vaccination is to stimulate the body to produce antibodies against this protein to intercept viruses before they enter cells and multiply.
Biontech and Pfizer hope to be able to provide up to 50 million doses of vaccines worldwide this year, and next year they expect up to 1.3 billion doses.
Countries like Russia, China and recently Bahrain have already launched vaccines with restrictions and are already vaccinating parts of the population with them. But how well these vaccines actually protect and what side effects they can have is currently largely open.
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