First Clinical Trial of a COVID-19 Vaccine in Germany

24 April 2020

GMP News

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). In the authorised first part of the authorised clinical trial, 200 healthy volunteers aged between 18 and 55 years will be vaccinated in each case with one or more than one variants of the vaccine, each of which is slightly modified. After an observational waiting period, additional volunteers of the same age range will be vaccinated in the second part of the clinical trial. The additional inclusion of persons with an increased infection risk or an increased risk of a serious course of a COVID-19 disease is planned for the second part of the clinical trial, for which additional study data are required to be submitted in advance.

In the authorised part of the clinical trial, different variants of the RNA vaccine candidates are tested. In addition to their tolerability, their ability to create an immune response to SARS-CoV-2 after a specific amount of RNA (dose) is also tested (first dose finding). In this context, different RNA types and different lengths and modifications of the spike protein are tested, as well as the effect of a second vaccination.

This is the fifth authorised clinical trial world-wide in which a preventive specific COVID-19 vaccine candidate is tested in humans.

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