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reMainz biotech company Biontech is about to make a breakthrough with its potential corona vaccine. Biontech and its US partner Pfizer presented positive efficacy data Monday from the crucial vaccine study. Consequently, the risk of developing Covid-19 for study participants who received the vaccine was more than 90 percent lower than without the vaccine.
Biontech and Pfizer are the first companies worldwide to have submitted successful study data with a corona vaccine, which is crucial for approval. “This is the first evidence that Covid-19 can be prevented with a vaccine in humans,” Biontech chief Ugur Sahin told Reuters.
With 60 to 70 percent effectiveness previously expected for early vaccines, “more than 90 percent is exceptional,” Sahin said. “It shows that Covid-19 can be controlled,” Sahin said in an interview with Bloomberg. “Ultimately, it really is a victory for science.”
The two partners plan to apply for emergency approval for the vaccine in the United States later this month. If there is enough data on the safety of the vaccine, which is expected in the third week of November, the application should take place soon after. So far, the study has not raised any serious safety concerns.
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.
The protective effect must be observed for two years.
In the study, a total of 94 cases of the disease were confirmed as of Sunday. According to the information, the results will only be finally evaluated 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.
Infectiologist Gerd Fätkenheuer from the Cologne University Hospital spoke of “great 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 Hospital hoped that approval would be available 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. 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 an RNA vaccine
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.
Many governments have previously secured millions of doses of the vaccine, including those in the US, Japan and the UK. The European Commission has also concluded exploratory talks with companies on the purchase of up to 300 million cans.
The promising data boosted Biontech and Pfizer stocks ahead of trading on Monday. Shares from Pfizer rose about 9 percent, while stocks from the Mainz-based biotech company rose about 16 percent to $ 107. The announcement also caused the price of the German stock index (Dax) to skyrocket. The stock market barometer temporarily rose at midday in Frankfurt am Main by a good five percent compared to the closing price of the previous day. Shortly after 1 p.m., the leading German index rose 4.82 percent to 13,082 points.
Spahn: “Very encouraging” progress
Federal Health Minister Jens Spahn (CDU) described the progress as “very encouraging.” Spahn said the results showed “that this vaccine makes a difference.” He is very pleased that a German company is one of the first to achieve such success. However, of course, more experience will have to be expected. “That does not mean that the approval will take place tomorrow.”
Jens Spahn comments on the Biontech vaccine and the new vaccination strategy
Since a corona vaccine could not meet the needs in the initial phase for a long time, the vaccination doses must be distributed systematically. Here he explains what strategy the Federal Minister of Health, Jens Spahn, is following.
Spahn explained that FDA approval would first be approval in the US “This can result in a time difference between US and European approval.” But it is assuming a parallel application to the European Medicines Agency (EMA). As German health minister, he wanted to make sure that a vaccine from a German company “is not available in other countries first.”
The ongoing process (continuous review process), in which individual parts are submitted before the full application for approval, does not mean “that the requirements will be reduced,” Spahn said. The process could go faster this way.
The future president of the United States, Joe Biden, in a statement issued on Monday, congratulated “the brilliant women and men who contributed to this advance”, but warned that “the end of the fight against Covid-19 is still months away. “.
Even if “some Americans are vaccinated later this year, it will be many months before there is a widespread vaccination in this country,” Biden said. “Today’s news does not change that reality. Americans must rely on masks, distancing, contact tracing, hand washing, and other measures to stay safe for the next year. “
