Coronavirus : first COVID-19 vaccine trial authorized in Belgium

The Federal Agency for Medicines and Health Products (FAMHP) has authorized the first clinical trial evaluating a vaccine against COVID-19 in Belgium. This is the candidate vaccine from the German biotech firm CureVac.

This authorization is the result of a careful assessment of the candidate vaccines risk/benefit profile as well as the methods that will be used in the clinical trial. Thanks to the scientific advice provided by the FAMHP throughout the development process, the agency was able to complete the authorization procedure within 15 days.

The candidate vaccine is a RNA (ribonucleic acid) vaccine that contains the genetic information for the production of the spike protein from the new SARS-CoV-2 coronavirus.

This clinical trial is a phase 1 study that aims to enroll 168 healthy volunteers, aged 18 to 60, in Belgium and Germany. After preclinical development, the objective of first-in-human studies is to evaluate the safety and general tolerance of candidate vaccines and to determine whether a specific immune response is triggered against the pathogen.

In this study, the dose will be gradually increased in order to identify the most appropriate dose in terms of safety and immune response. This study should make it possible to identify the appropriate dose for further development and to rapidly initiate a larger study evaluating the efficacy of the candidate vaccine. 

The availability of safe and effective COVID-19 vaccines is an important objective in the fight against SARS-CoV-2. Clinical trials of candidate vaccines in humans are an important step towards the marketing authorization for safe and effective vaccines against COVID-19. According to the World Health Organization (WHO), this is the 11th clinical trial authorized worldwide for a COVID-19 candidate vaccine. Further clinical trials of COVID-19 candidate vaccines are planned in Belgium in the coming weeks.

 

Last updated on
22/06/2020