China gives the go-ahead for human trials of BioNTech’s COVID vaccine candidate
The potential vaccine is one of the two most advanced candidates that BioNTech is working on with its partner Pfizer and they received “fast track” status this week from the US Food and Drug Administration which is designed to speed up the regulatory review process
China has approved an early-stage trial in humans of German firm BioNTech’s experimental COVID-19 vaccine, its local partner Shanghai Fosun Pharmaceutical said.
The potential vaccine is one of the two most advanced candidates that BioNTech is working on with its partner Pfizer and they received “fast track” status this week from the US Food and Drug Administration which is designed to speed up the regulatory review process.
Fosun Pharma said in a filing that a unit will initiate a Phase I clinical trial of BNT162b1 “as soon as possible once it is ready”.
It is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan.
The candidate is one of at least 23 being tested on humans in a frantic global race to find a vaccine the world is counting on to end a pandemic that has infected more than 13 million people and killed more than half a million.
Prior to the latest approval, Chinese researchers and companies have moved eight vaccine candidates into different phases of human trials at home and abroad.
Fosun Pharma agreed in March to pay up to $85 million in licensing fees to use BioNTech’s proprietary mRNA technology and invest $50 million for a stake in the German firm.
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