Germany’s vaccines regulator approved live human testing of a potential vaccine against COVID-19 developed by German biotech company BioNTech, the regulator said in a statement on Wednesday (Apr 22).
The trial – only the fourth worldwide – will be conducted on 200 healthy people aged between 18 and 55 in the first stage, said regulatory body Paul-Ehrlich-Institut (PEI).
The preventive agent targeting the virus behind the global pandemic will be tested on more people, including those at higher risk from the disease, in a second stage.
BioNTech said it is developing the vaccine candidate, named BNT162, together with its partner, pharma giant Pfizer.
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Tests of the vaccine have also been planned in the United States, once regulatory approval for testing on humans had been secured there.
The trial is a “significant step” in making a vaccine “available as soon as possible”, said PEI.
It added that the approval was the “result of a careful assessment of the potential risk/benefit profile of the vaccine candidate”.
Neither the institute nor the developers specified when the trial will begin, although BioNTech claimed in a statement that it would be “soon” and “ahead of our expectations”.
The institute also said that “further clinical trials of COVID-19 vaccine candidates will start in Germany in the next few months”.
