COVID-19: First clinical trial of a vaccine in Germany approved
World’s scientists conduct research on vaccines against the novel Coronavirus SARS-CoV-2. In Germany, it has now been approved for the first time, a clinical trial of a vaccine. The agent will be tested in healthy volunteers.
Now have infected several million people worldwide with the new Coronavirus. Not only the disease itself, but also with the pandemic associated restrictions make the lives of people. According to experts, the social Isolation should be obtained approximately by the year 2022 to maintain, if not before, vaccination against the pathogen is available. Now first vaccine Tests in Germany of the people.
Challenge can be mastered
The Corona pandemic, the people in Germany and around the world a never seen before challenge. Nevertheless, professionals are convinced that this challenge can be mastered.
As the Federal Ministry of education and research (BMBF) writes, can put the society on the research. Researchers working in this country and around the world under high pressure.
As it comes to the development of new drugs for the treatment of the disease. And it is also about the development of a vaccine. “This is, of course, the best way to the Virus back. But: The development of a vaccine is very time-consuming,“ writes the BMBF.
But now we come closer to the middle, possibly a step. Because according to a recent communication from the Paul-Ehrlich-Institute (PEI), Federal Institute for vaccines and biomedical pharmaceuticals has approved the first clinical trial of a vaccine against COVID-19 in Germany.
The Central goal of tackling the rampant spread of Coronavirus
As PEI explained, is the provision of approved safe and effective COVID-19-vaccines, a key objective for the fight against the rampant spread of new SARS-Coronavirus-2 (SARS-CoV-2).
First clinical trials have the objective to assess the General tolerability of the vaccine candidates and their ability to generate a specific immune response against the Virus.
According to the notice for the approval of clinical trials as well as evaluation and authorisation of vaccines in Germany, the competent Paul-Ehrlich-Institut supports the COVID-19-vaccine development a top priority.
Disease prevent or mitigate
In the case of the well test vaccine candidates of the Mainz-based biotechnology company BioNTech is a so-called RNA vaccine contains the genetic Information for the construction of the so-called spike protein of CoV-2, or Parts thereof, in the Form of ribonucleic acid (RNA).
As the experts will explain the vaccination with the RNA vaccine of the genetic Information for the construction of a harmless Pathogen component by means of injection, for example, into the muscle administered.
The RNA is included in some of the body cells of the vaccinated people. These body cells use the genetic Information to the RNA for the construction of the Excitation component. So in the vaccinated individuals produced by the excitation components are not infectious and do not disease.
The human immune system detects the foreign pathogen component, and considers the cells that have built these pathogens become part of the supposedly-infected cells. It is a protective building at the end of an immune response against the Virus, which prevents in the event of an exposure to the infection, or at least the infectious disease or its course of reducing it.
Clinical trial in healthy Participants
In the approved the first part of the clinical trial, 200 healthy subjects and subjects aged 18 to 55 years, with each one of a plurality of low-modified vaccine variants in vaccinated.
After waiting for the observation of the Vaccinated clinical examination for further study in the second part participants vaccinated by the end of the same age range.
The additional inclusion of female subjects and subjects with an increased risk of infection or with an increased risk for a severe course of a COVID-19-condition is provided in the second part of the clinical examination, for the preliminary study data must be submitted.
Further tests in the coming months
According to the figures available in the approved part of the clinical trial will be tested different variants of the RNA vaccine candidates. In addition to the compatibility first dose of determination) will be examined according to the PEI, the ability to generate an immune response to SARS-CoV-2 after administration of a specific RNA-amount (dose) (.
Different RNA are tested for types and of different lengths, and modifications of the spike protein and the influence of a second vaccination tested.
This is only the fourth authorized the testing of preventive, specific COVID-19 vaccine candidates in humans. In view of the serious consequences of the COVID-19-pandemic, this is a significant step to develop a effective and safe COVID-19 vaccine as soon as possible in Germany and, if possible, to be available worldwide, writes of the PEI.
The experts of the Paul-Ehrlich-Institut according to the current state of knowledge, thereof, that further clinical trials of COVID-19 vaccine candidate will begin in Germany in the next few months.
For the control of the Corona pandemic, multiple vaccine products will be required to have a sufficient supply. (ad)