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The Clinical Phase I pilot program in China recruited 144 healthy subjects to assess the safety and immunogenicity of the candidate vaccine and determine dose selection.
in the first phase of clinical studies, the first group of subjects inoculated will be healthy adults (18-55 years old), followed by healthy older adults (over 55 years of age).
as part of a two-dose cohort design, subjects will be given two injections, 21 days apart, with 10 micrograms or 30 micrograms of candidate vaccine or placebo. The selection of
dose range is based on early data from previous clinical trials in Germany and the United States.
subjects will be tested at the Phase I clinical base in Taizhou, Jiangsu Province.
the study will be conducted in accordance with regulatory approval procedures in China and further confirm that the safety and immunogenicity observed in subjects in The German and U.S. trials are comparable to those observed in China.
ongoing clinical studies in Germany and the United States will continue to support research in China.
Clinical studies in China will be the first to evaluate the nucleoside-modified messenger RNA (modRNA) candidate BNT162b1, one of two vaccines based on BioNTech proprietary mRNA technology and has been FDA fast-track certified, following ongoing phase 1/2 studies in Germany and the United States.
, bnT162b2, another FDA fast-track-certified candidate, is being evaluated in a global Phase 2b/3 clinical trial by BioNTech and Pfizer, which began July 27.
Fosun Pharma and BioNTech plan to continue to explore and advance the possibility of other candidate vaccines based on BioNTech proprietary mRNA technology for clinical trials in China.
during clinical development, BioNTech will provide clinical availability of vaccines through its GMP-certified mRNA manufacturing facilities in Europe.
if the vaccine is licensed for sale in the future, Fosun Pharma will exclusively commercialize COVID-19 vaccine products based on the BioNTech mRNA technology platform in Chinese mainland and Hong Kong, Macao and Taiwan.
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