BioNTech and Fosun Pharma kick off Chinese COVID-19 trials
BioNTech SE and its partner Fosun Pharma Co. Ltd have selected another COVID-19 vaccine candidate for Phase I testing in China than tested in global Phase III trials.
In principle, the extended Phase I safety trial will copy a successful safety trial conducted with the modified mRNA COVID-19 vaccine BNT162b1 that was sponsored by BioNTechs global commercialisation partner Pfizer Inc. At the end of July, BioNtech and Pfizer announced they have selected BNT162b2 for global Phase III testing in up to 30,000 healthy volunteers. Up to know, the companies haven’t published any results of Phase I testing with BNT162b2. Meanwhile, the companies announced they have made supply agreements with the US and Canada.
The Chinese trial will enrol 144 healthy volunteers in two groups, who will receive either two doses of 10µg or 30 µg: one group with people aged from 18 – 55, the other group with volunteers older than 55 years of age. Safety and immunogenicity will be compared to placebo.
In the global trial, titers of virus-neutralising antibodies exceeded the limit defined by the US regulatory agency FDA and the jab was well-tolerated.
Biocytogen Co Ltd
Draupnir Bio ApS