China's revolutionary mRNA vaccines for COVID-19 may hit market within this year

Dr. E. Kwok administers a COVID-19 vaccine to a recipient at a vaccination clinic run by Vancouver Coastal Health, in Richmond, British Columbia, Saturday, April 10, 2021. AP

China is on course to produce its own version of the revolutionary new vaccines that use genetic technology to stimulate the immune system by the end of the year, according to a senior industry figure.

The two available mRNA vaccines designed to tackle Covid-19 - produced by Moderna and Pfizer-BioNTech - have a higher efficacy rate than those produced using other forms of technology.

"We fully expect that there is a high possibility that a domestic mRNA vaccine will hit the market by this year," said Feng Duojia, president of the China Association of Vaccines.

"We increasingly feel that we must master the core theories and technologies ... because no one can help our country solve all the immunisation problems once a global public health crisis like Covid-19 breaks out. We must have a long-term strategy," he added.

A senior executive with Walvax, who declined to be named because he was not authorised to speak to the media, said there would be uncertainties concerning regulatory approval for product launch.

Feng said an mRNA vaccine jointly developed by the Academy of Military Science (AMS), Walvax Biotechnology and Suzhou Abogen Biosciences, has completed its phase 1 and 2 human trials with "satisfactory" results. He continued that plans for phase 3 trials in multiple sites overseas were under way and expectations were "very good".

Walvax started building a production facility in December with a first-phase annual capacity of 120 million doses.

Another mRNA vaccine jointly developed by Shanghai-based biotechnology company Stemirna Therapeutics and Shanghai East Hospital, started human trials last month, two months after it obtained regulatory approval to do so.

Meanwhile, Fosun Pharmaceutical, which has a licensing deal with BioNTech in the Greater China area, is still sorting through data from phase 2 trials held in Jiangsu province. It has already started delivering batches of the Covid-19 vaccine to Hong Kong and Macau.

Fosun is co-developing the vaccine by having early stage trials on the mainland before using phase 3 data from overseas to seek mainland China's regulatory approval."The preparations at the production facility are ready ... After effective results are obtained through these trials, an application will be submitted to the relevant government agency immediately, with the hope to start domestic production of the foreign vaccine in China," Feng said.

Containers with the vaccine against COVID-19 produced by China' Sinopharm are stored in the logistics center of Hungarian pharmaceutical wholesaler Hungaropharma in Budapest, Hungary, February 16, 2021. EPA-Yonhap

Feng said the developers are "racing against time without relaxing for a moment" and the production facilities were being prepared before the trial results were known in a break with the usual practice of waiting until the drug's effectiveness has been proven.

"We are latecomers and will still have some time before the products are approved, but these products feature Chinese innovation and intelligence with independent intellectual property rights and patents for the core parts of the production process and core technology. We do not have to worry about technical bottlenecks and obstacles in the future," Feng said.

The Chinese vaccines currently in use are inactivated vaccines, which take dead matter from the coronavirus to stimulate the immune system. But the radical new vaccines use messenger RNA to copy the virus's genetic profile and train the body into mounting an immune response.

The technology has a number of advantages, including a shorter development time if changes are needed to combat viral variants and better biosafety because there is no need to handle live viruses as part of the production process.

That synthetic mRNA is wrapped in an oily coating made of lipid nanoparticles (LNP), which helps deliver the vaccine and is considered the key technology for unlocking its potential.

Only a handful of companies supply LNP, including Germany's Merck and Evonik, Switzerland's Corden Pharma and Canada's Acuitas. Walvax has developed its own LNP for the vaccine and Stemirna said it has developed its own nano delivery system using lipopolyplex.

According to a paper published in Cell, the Walvx-Abogen-AMS candidate vaccine can be kept at room temperature for up to a week, whereas the Pfizer-BioNTech product needs to be stored well below zero and the Modena vaccine can be kept in a fridge for up to a month, but needs ultra-low temperatures for longer term storage.

Jay Lee, an analyst for the investment company Morningstar, said mRNA platforms are in the early stages of development, but potentially have broad applicability in other areas beyond Covid-19, such as infectious diseases and cancer. He believes Chinese companies will eventually be competing with global players in developing the technology.

"In the long-run, many Chinese biotech companies want to compete in the global markets, especially the US market which offers far more lucrative pricing compared to most other countries, including China. This requires early investment in new drug targets and modalities, including mRNA platforms which could ultimately prove to have broad applicability beyond Covid-19," Lee said.