“The Paul-Ehrlich-Institut (PEI)… has authorised the first clinical trial of a vaccine against Covd-19 in Germany,” the regulatory body said in a statement.
It added that approval was the “result of a careful assessment of the potential risk/benefit profile of the vaccine candidate.”
The move gives the green light for testing to be carried out on human volunteers for an RNA vaccine developed by Mainz-based firm Biontech.
The biotech firm is working with the US pharmaceutical company Pfizer for the development of the vaccine.
The trials will see “200 healthy volunteers aged between 18 and 55 years” vaccinated with variants of the RNA vaccine, while the second phase could see the inclusion of volunteers who belonged to high-risk groups, said Biontech.
Neither PEI nor the developers specified when the trial will begin, though Biontech claimed in a statement that it would be “soon” and “ahead of our expectations”.
The institute said the testing was an “important milestone” on the path to find “safe and effective vaccines against Covid-19 for the population in Germany and beyond”.
According to the Association of Research-Based Pharmaceutical Companies, at least 80 vaccine projects have been initiated since the outbreak of the Covid-19 pandemic.
The trial is the fourth to have been authorised worldwide.
Institute President Klaus Cichutek has said further clinical vaccine trials are expected to start in Germany this year.
However, Cichutek believes it's unlikely that an approved vaccine will be available for the general public this year.
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