A COVID-19 vaccine at the Research Centers of America Photo: AFP

An mRNA vaccine against the coronavirus co-developed by a German Biotech company BioNTech, a Chinese pharmaceutical company Fosun Pharma and a US Pharmaceutical company Pfizer has entered late-stage clinical trials and could be available for mass inoculations in the winter if successful, Hui Aimin, President of Global R&D, and Chief Medical Officer of Fosun Pharma, told the Global Times on Saturday.

Assuming clinical success and approval of the vaccine candidate, named BNT162b2, the producer will offer a 10 million dose deal that will be available to 5 million people in Hong Kong to help the city combat the latest wave of infections. The vaccine apparently requires a person to receive two shots 21 days apart, according to the company.

During the clinical development stage, BioNTech provides the clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities, while Fosun Pharma specializes in clinical trials design and execution, regulatory approval and commercializing the vaccine in China.

Fosun Pharma is on track to seek approval from China's National Medical Products Administration to start a bridging clinical trial in China of BNT162b2 that will link up with the ongoing phase 3 trials overseas as soon as possible, Hui told the Global Times. Bridging clinical trial data in China together with global phase 3 data is required before the vaccine can be approved for use in China.

Bridging clinical trials in China will focus on comparing the data from domestic and overseas trials to find any potential differences in immunogenicity and safety of the vaccine candidate that may be caused by factors such as environmental or genetic differences.

More than 25,000 participants have already been enrolled in phase 3 trials being conducted overseas, and results are expected in October. 

Cooperation on vaccine development is one example of global companies working together. In a virtual meeting on Monday, leaders from China, German and the EU called for strengthened efforts to advance cooperation and better handle challenges in a post-pandemic era.

Hui said that the partnership came from their trust in BioNTech's advantages of mRNA vaccine technology. "It takes less time to develop an mRNA vaccine which means one can get a vaccine design as quick as several days and produce a vaccine candidate for test as soon as four to six weeks after obtaining the gene sequence of the virus," said Hui. 

Based on current observations, coronaviruse seems to mutate at relatively lower rates than other families of virus such as seasonal flu and HIV/AIDS, and the majority of mutations detected thus far in SARS-CoV-2 (the virus causes COVID-19 disease) are located outside of the Spike protein which is critical for SARS-CoV-2 to enter host cells. Additionally, emerging data suggests that mutations may affect the transmission of SARS-CoV-2 but appears to have little effect on antigenicity, said Hui. 

The mRNA vaccine can also trigger double immune responses - humoral and T cell responses - to better protect people through dual mechanisms. The mRNA vaccine itself does not contain any viral components which represents a safer choice for people with fewer concerns.

BioNTech and Pfizer jointly announced in August that, if approved, up to 100 million doses of vaccine worldwide would be produced by the end of 2020 and approximately 1.3 billion doses by the end of 2021.