COVID-19: China’s first mRNA vaccine ready for final stage trials overseas

Zhuang Pinghui, South China Morning Post

Posted at Apr 14 2021 12:51 PM

COVID-19: China’s first mRNA vaccine ready for final stage trials overseas 1
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in front of displayed China flag in this illustration taken, October 30, 2020. Dado Ruvic, Reuters/File

China’s first domestically developed mRNA vaccine is ready to start its final stage trials overseas next month, its developer has told state media.

The vaccine – which uses the same advanced revolutionary techniques as the drugs developed by Pfizer-BioNTech and Moderna – is at the end of phase 2 human trials and will start large-scale phase 3 trials next month, Ying Bo, founder and chief executive of Suzhou Abogen Biosciences, told China National Radio.

The vaccine, known as ARCoV, has been jointly developed by Abogen, the Academy of Military Science and Walvax Biotechnology.

It works by introducing engineered messenger RNA that instructs cells to produce proteins that help the immune system recognise the virus.

Trials show the two mRNA vaccines already in use offer more than 94 per cent protection and Ying said early stage trials showed the ARCoV vaccine might just be as promising.

“Whether it is pre-clinical animal trials or human trials, or a clinical experiment, from the results we got, the domestically produced ARCoV vaccine can be fully comparable to the two overseas mRNA vaccines,” Ying said.

Last week Feng Duojia, president ofthe China Association for Vaccines, said ARCoV had completed phase 1 and 2 trials with “satisfactory” results and he had “very good” expectations for the phase 3 trials.
Walvax started building a production facility for mRNA vaccines in Yunnan province last December with a first-phase annual capacity of 120 million doses.

Ying told China National Radio that production could start as early as the third quarter.

Ying said mRNA vaccines could offer good protection if administered alone and could also be used to supplement vaccines using other techniques.

“The messenger RNA platform responds fastest to virus variants thanks to quick development and production.

Mixed administration of vaccines can achieve better effects in resisting variants than just taking two single shots,” Ying said.

Gao Fu, head of the China Centre for Disease Control and Prevention, told a conference in Chengdu over the weekend that China is considering whether to mix vaccines using different technologies.

Tigermed, a Hangzhou-based clinical contract research organisation, will be responsible for conducting the overseas trials, Ying said. Walvax has yet to announce the final sites for the trials, but it signed a memorandum of understanding with Mexico for phase 3 trials last August.

Abogen announced last week that it has raised 600 million yuan (US$92 million) in the second tranche of funding for the development of its mRNA vaccine, and would also establish a production facility to work on vaccines and treatment for cancer and infectious diseases.

The mRNA vaccines, though effective against Covid-19, are difficult to store and transport. The molecular mRNA needs to be wrapped in an oil coating made of lipid nanoparticles, something only a handful of companies are able to supply, and the vaccines need to be stored at very cold temperatures.

Abogen said earlier that it has developed its own lipid nanoparticles and stated in a paper published in the journal Cell last July that ARCoV could be kept at room temperature for up to a week.