BioNTech and Fosun Pharma have begun a phase 2 trial of their COVID-19 vaccine in China. The trial will generate data to support a filing for approval of the vaccine, which is nearing authorization in the West, in China.
Fosun partnered with BioNTech in March in a deal worth up to $135 million. In July, Fosun advanced mRNA vaccine BNT162b1 into phase 1, only to follow BioNTech’s lead and prioritize another asset after getting a look at data from the global development program. The phase 2 trial will assess the performance of that second vaccine, BNT162b2, in the Chinese population.
Jiangsu Provincial Center for Disease Control and Prevention will run the trial and recruit 960 people aged 18 to 85 years. Recruitment in the placebo-controlled trial will take place online. Three-quarters of participants will receive the vaccine.
The primary endpoint is looking at humoral immune responses one month after the administration of the second dose of BNT162b2. Specifically, the investigators are interested in seroconversion rates and the geometric mean titer of SARS-CoV-2 serum neutralizing titers. Other endpoints are looking at the safety and tolerability of the vaccine seven and 14 days after each vaccination.
Working with Pfizer, BioNTech has already generated a large body of data on the immune responses and adverse events seen in Western populations. The new phase 2 trial will show whether BNT162b2 performs comparably in Chinese people.
Fosun has previously said a successful bridging study could enable it to extrapolate global data to the Chinese population, potentially setting it up to leverage BioNTech and Pfizer’s successful phase 3 to win approval in its home market. Fosun sees benefits to the study beyond the generation of results to support a filing for approval in China.
“The phase 2 clinical study with BNT162b2 in China will not only provide key data for the launch of the vaccine in China, but also may play a positive role in the widespread promotion and use of the vaccine throughout Asia and around the world,” Aimin Hui, M.D., Ph.D., chief medical officer at Fosun, said in a statement.
BNT162b2 is already on the cusp of approval, at least on an emergency basis, in the U.S., Canada, the EU and the U.K. on the strength of a phase 3 trial that found a 95% efficacy rate in stopping symptomatic COVID-19.