SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.
Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.
The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States after enough safety data is provided as early as this month.
But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.
Hui said he did not regret testing BNT162b1 without waiting for more complete data.
“For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?”
Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.
A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.
Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.
Fosun 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. In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.
NOVEMBER 4, 2020