The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised the first clinical trial of a vaccine against COVID-19 in Germany. The authorisation of this trial is the result of a careful assessment of the potential risk/benefit profile of the vaccine candidate. Based on extensive scientific advice to the medicine developer, BioNTech, in the preliminary phase, the Paul-Ehrlich-Institut was able to complete the authorisation procedure within four days.
The provision of authorised safe and efficacious COVID-19 vaccines is a central aim in combating the rampant new SARS Coronavirus-2 (SARS-CoV-2). First clinical trials aim at investigating the general tolerability of vaccine candidates as well as their ability to induce a specific immune response against the pathogen. The early and extensive scientific advice performed by the Paul-Ehrlich-Institut ensures that the development of a vaccine is accelerated in a targeted manner while still fulfilling to the necessary scientific requirements.
The vaccine candidate of the Biotechnology company BioNTech at Mainz is a so-called RNA vaccine, which 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)...
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