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• The Paul-Ehrlich-Institut has approved the P-I/II clinical study evaluating BioNTech’s BNT162 vaccine program to prevent COVID-19 infection. The clinical study is the first COVID-19-related trial to be initiated in Germany
• The P-I/II study’s dose-escalation portion will include ~200 healthy subjects aged 18-55yrs. and will target a dose-ranging 1-100 µg to determine the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine. The companies are expected to initiate the clinical study in the US
• The study will evaluate the effects of repeated immunization for 3 of the 4 vaccine candidates which utilize uRNA or modRNA. BioNTech will ensure the clinical supply of vaccine from its GMP-certified mRNA manufacturing facilities in the EU

Click here ­to­ read full press release/ article | Ref: Business wire | Image: RTTNews

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