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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. As Mainz-based pharmaceutical company Biontech announced on Monday, based on this data, its vaccine offers more than 90 percent protection against the Covid-19 disease. He also said that Biontech and the pharmaceutical giant Pfizer are expected to apply for approval from the US FDA starting next week.
The BNT162b2 vaccine had been developed by Biontech in the “Lightspeed” project since mid-January. The phase III study, crucial for its approval, began in several countries in late July. 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.
In the study, a total of 94 cases of the disease were confirmed as of Sunday. According to the information, the preliminary results will only be evaluated conclusively when a total of 164 cases is reached. In addition, it will be verified to what extent the vaccine not only protects against Covid-19, but also against the serious courses of the disease. In general, both the protective effect and the side effects should be observed over a period of two years.
Data should be discussed around the world
The first interim analysis is preliminary effectiveness data, so vaccination effectiveness may still change after a longer observation period of test persons. The Data Monitoring Committee (DMC) also reported that “there are no serious safety concerns” and recommended that the study continue as planned with the collection of additional safety and efficacy data. In the meantime, the data will be discussed with other regulatory authorities around the world, including the US FDA and European Ema. Apparently a scientific publication is in preparation.
“These are excellent and promising data,” said Gerd Fätkenheuer, head of infectology at Clinic I for internal medicine at the University Clinic Cologne. “It is incredible that in such a short time this progress, with the development of vaccines and clinical trials, can be achieved in a few months.” The results so far on efficacy 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 leading a vaccine study, said: “These are interesting first signs, only given in the press release.” The primary data is not yet available and a peer-reviewed publication is pending. “We have to wait for the exact dates to do a final evaluation. At the moment, there are still few details about the exact dates, for example regarding the different age groups and in which groups the 94 cases occurred.”
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. 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 viral protein, in this case the surface protein that the virus uses to enter 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.
