For the first time, a corona vaccine tested according to western standards provides evidence: There is protection against infection. The experts are reacting optimistically: There is talk of a “giant leap” and a “silver lining”. However, experts also express concerns. It may be a decisive step in the fight against the coronavirus pandemic: The Mainz-based company Biontech and the pharmaceutical company Pfizer were the first western manufacturers to publish promising results of a study that was crucial for approval. Accordingly, your vaccine offers more than 90 percent protection against the disease Covid-19. Serious side effects have not yet been registered, it said. The reactions from the professional world are accordingly confident: The virologist Florian Krammer from the Icahn School of Medicine in New York called the announcement the “best news” for him since the beginning of the pandemic, he writes on Twitter. And he even lets himself be carried away to assess: “Dear world. We have a vaccine!”
Clemens Wendtner from the Munich Clinic Schwabing expressed himself somewhat more cautiously, for whom the presented results are at least a “silver lining on the otherwise gloomy horizon”. In the event of approval, Wendtner is hoping for a quick start to vaccination: “If this step is taken, a wave of vaccinations could indeed start by the end of 2020.”
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The infectiologist Gerd Fätkenheuer from the Cologne University Hospital spoke of “great and promising data”. “I think this will have a major impact on how we deal with the pandemic, and I hope that large quantities of the vaccine will be available quickly.” However, experts also indicated that the data initially only come from a press release and not from a scientific publication. For example, there was a lack of information on the protective effect in certain age groups and how long vaccination protection lasts.b World Medical President Frank Ulrich Montgomery spoke of a “giant leap forward”, but also warned that it was not yet a “breakthrough”. Scientific work was still missing, said Montgomery to the editorial network Germany. He also pointed out that “great experience with RNA vaccines”, whose mechanism of action is based on ribonucleic acid, “does not yet exist”. The SPD health expert Karl Lauterbach rated the vaccine a “breakthrough”. “There are interim results, but these interim results are clearer than expected in professional circles,” said Lauterbach. “That’s great.” It is also a vaccine that is likely to have few side effects. “I was always firmly convinced that we would get the vaccine,” said Lauterbach. He could imagine that the vaccine could be used for the first time in January.
Biontech had been developing the BNT162b2 vaccine in the “Lightspeed” project since mid-January. The phase 3 study, which is crucial for approval, began in various countries at the end of July. By Monday, more than 43,500 people had 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 Covid 19 cases were confirmed by Sunday — half of the participants in the study received a vaccination, the other half only a placebo. But neither the participants, nor the company or the participating doctors know who has received what. Only after a certain number of participants become ill is it checked how many of them have received the vaccine and how many have received the placebo.
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An interim result has now been drawn from 94 patients. Finally, according to information from Biontech and Pfizer, the results are only evaluated when a total of 164 participants are sick. It will also 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. The Biontech preparation is a so-called RNA vaccine, which is based on a completely new mechanism. 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 enter 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. One advantage of RNA vaccines is that they can be produced much faster than conventional vaccines. Biontech and Pfizer expect up to 50 million vaccine doses to be made available worldwide this year and up to 1.3 billion doses in the coming year.
Up to 300 million Biontech vaccine doses for the EU
The EU Commission has been negotiating with Biontech / Pfizer about a framework agreement for the delivery of the vaccine to all EU countries for some time. There is nothing new about this, said a commission spokesman on Monday afternoon. The commission had already announced in September that it wanted to order up to 300 million vaccine doses from Biontech. So far, she has signed framework agreements with the pharmaceutical companies Johnson & Johnson, Astrazeneca and Sanofi-GSK.
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An accelerated approval process applies to corona vaccines due to their particular urgency. Manufacturers can submit individual parts on the quality, safety and effectiveness of a preparation to the European Medicines Agency even before the complete application for approval. In addition to Biontech, the British-Swedish company Astrazeneca has started such a rolling review process for its vaccine candidate. Astrazeneca has not yet released any phase 3 data. A spokeswoman said nothing can be said about the schedule. 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. The World Health Organization is optimistic about progress in developing a vaccine against the coronavirus. If it is delivered by March next year to those who are most susceptible to the virus, the course of the pandemic could take a fundamentally different direction, said WHO top representative Bruce Aylward. Aylward called the announcement by the pharmaceutical companies BionTech and Pfizer that their vaccine candidate is showing a high level of effectiveness and that they intend to submit an application for approval in the USA in November.