BioNTech and Shanghai Fosun Pharmaceutical have started dosing participants in a Phase I clinical trial of Covid-19 vaccine candidate, BNT162b1.
Following China’s National Medical Products Administration (NMPA) approval, the first 72 volunteers have already been dosed in the trial.
The companies are co-developing the vaccine candidate in China. The trial falls under BioNTech’s global development programme.
During the randomised, placebo-controlled, observer-blinded trial, a total of 144 healthy participants will be enroled in China. It will assess the safety and immunogenicity of the vaccine, and also confirm dose selection.
The first stage of the trial will involve healthy volunteers aged 18 to 55, followed by elderly healthy participants aged above 55. Participants will be given two doses of either a 10µg or 30µg dose of the vaccine or placebo, 21 days apart.
This dose range selection was based on early data from trials conducted in Germany and the US.
Intended to support the regulatory approval in the Chinese market, the latest trial will compare the safety and immunogenicity profile demonstrated in the German and US trials to that of Chinese participants.
BioNTech CEO and co-founder Ugur Sahin said: “We are proud to be among the first international biopharmaceutical companies to initiate a clinical trial of a Covid-19 vaccine candidate in China as part of our effort to make our vaccine available globally, if approved.
“This is an important step toward our goal to reach marketing authorisation and ensure vaccine supply in China to help prevent new Covid-19 outbreaks in the most populous country in the world.”
During the clinical development, BioNTech will deliver the clinical supply of the vaccine from its mRNA manufacturing facilities in Europe.
If marketing authorisation is granted, Fosun Pharma will be responsible for exclusive commercialisation of the vaccine in mainland China, Hong Kong, Macau, and Taiwan.