Institute name of Paul Erlich, subordinate to the Ministry of health of Germany, allowed the biotech firm Biontech tested on humans it had developed a vaccine against COVID-19. Clinical studies will start in April.
Today in the world is working on approximately 60 similar projects. Five of them are under clinical trials. But, according to experts, the company Biontech, Mainz-based German, has a good chance to get ahead. No wonder after the news about the beginning of the “human” phase of testing, the company’s shares soared in price by as much as 64 percent.
His closest competitor, compatriot, company CureVac (tübingen), minzy already seriously ahead. Until recently, this firm went to the advanced workers vsegermanskogo competition to find the vaccines — all development are four independent from each other groups of researchers. But CureVac expects to begin clinical trials until June.
In the Biontech a project to create a vaccine called the “Speed of light”. Rates on industry standards, and indeed unprecedented. From the start of the second half of January, until the tangible results it has been two months.
“We are pleased that the preclinical studies successfully completed and we earlier than expected, we proceed to the first phase of human trials, said the founder and head of Biontech Ugur Sahin. — The speed with which the work progressed, indicating a high impact all who participated in it”. Clinical study is “an important milestone on the way to creating a safe and effective vaccine against COVID-19 for the population of Germany and the whole world,” echoes in his official statement, the Institute named Erlich.
Only, according to the developers, was received on 20 variants of the vaccine. All of them were initially tested on mice, he was tested primarily a safety matter. The results of this stage were selected in four modifications, which showed itself best. They will now be tested on humans.
In the first phase of clinical trials “candidate vaccines” will inject the first two hundred volunteers who are physically healthy men and women aged 18 to 55 years. Then, if all goes well, testing will involve 500 people, including representatives of risk groups — the elderly and/or having chronic diseases.
If the safety and immunogenicity of the drug are confirmed, will begin phase 2 with the participation of several thousand subjects. At last, the third stage will be vaccinated with 20 thousand people. The main task of this stage is to identify possible side effects.
According to the developers, clinical studies will take from three to five months. The first results are expected in June. As soon as the tested vaccine will be available to the doctors? The Minister of health of Germany Jens span full of optimism: according to him, before that “remain months.” However, most experts agree that mass vaccination can begin no earlier than early-mid next year.
That is, sadly, the second wave of the pandemic in Germany and the world, apparently, will again meet unarmed. According to experts the University hospital “Hamburg-Eppendorf”, “encore” coronavirus “will perform” in the early autumn. And repeated epidemic tsunami of worried physicians, no less than the first.
The situation is complicated by the fact that in August and September is also circulated as the “normal” flu, so-called type A, which is dangerous in itself. “The idea that it will connect with the COVID infection, causes us great concern,” laments Professor Burkhard Huck, head of the clinic.
But it is better in 2021 than never: no vaccine final victory over coronavirus, convinced scientists and physicians, impossible.
Development Biontech is a so-called RNA vaccine, explains the Institute named Erlich. The mechanism of action is as follows: in muscle tissue injected a substance containing genetic information, which our cells recreate the viral protein. It is safe for the human body, but is perceived by the immune system as a dangerous intruder — antigen. And activates and configures it accordingly.
The creation of new vaccines, and even in such a short time, — a lesson, of course, is not cheap. But it’s worth it, including in a purely financial sense. The journalists of the newspaper Bild pointedly indicate the name of the street on which the headquarters Biontec: An der Goldgrube. Translation — “the Golden bottom”.