China to test its own mRNA vaccine, biosecurity law enters into force
April 20, 2021 Category Health, Weekly
The first China-developed mRNA Covid-19 vaccine is expected to enter Phase III clinical trials overseas next month, vaccine developer Suzhou Abogen Biosciences confirmed. Production capacity could reach some 120 million doses this year, according to the company’s founder Ying Bo, which will be a major breakthrough in domestic mRNA vaccines’ research and development (R&D). Experts suggest that using different types of vaccines – inactivated, mRNA, or adenovirus ones – to inoculate people could deliver better immunity. Being able to be stored and delivered in the usual range of 2º to 8ºC will make this domestic ARCoV vaccine stand out from Western mRNA vaccines made by Pfizer-BioNTech and Moderna, which require much lower temperatures. “From animal and clinical trial results, we see that ARCoV is fairly competitive with the other two mainstream mRNA vaccines in overseas markets,” Ying said. The producer is applying to start ARCoV’s Phase III trials overseas, likely in Latin American countries, expected in early May. Abogen announced the completion of a B round of financing totaling CNY600 million to accelerate vaccine R&D and production.
Chinese vaccine producer CanSinoBio said hat it had not received any report of blood clots after vaccination of millions of people with its recombinant adenovirus vector Covid-19 vaccine, amid reports that inoculations with the AstraZeneca and Johnson & Johnson’s vaccines were discontinued in several countries. CanSinoBio said that, although its vaccine uses the same technique, it uses a different adenovirus than the other two companies. CanSinoBio uses adenovirus type-5 as vector, a common adenovirus among humans, while AstraZeneca uses a chimpanzee adenovirus and Johnson & Johnson uses an adenovirus type-26.
Fosun Pharma has also submitted clinical trial data of BioNTech’s Covid-19 mRNA vaccine to China’s state regulator for review, in preparation for importing the first foreign-made Covid-19 vaccine. Approval is expected within the next 10 weeks. As some expats in China requested more vaccine options, experts said that approval of such imports could benefit foreigners coming to China. Many expats living in China have wanted some foreign-made vaccines for easier recognition when they return home. Once approved, BioNTech and Fosun would initially plan to supply the vaccine from BioNTech’s state-of-the-art production facilities in Germany, and BioNTech may consider shipping the bulk vaccine substance to the Chinese mainland for further packaging. The vaccine was approved in January for emergency use in Hong Kong.
China’s first biosecurity law went into effect, marking a “major milestone” for upholding the rule of law in areas critical to people’s health, the environment and national security, experts said. The law introduced regulations in eight major categories – infectious disease prevention and control, regulating research and applications related to biotechnology, biological laboratory safety and practices, protecting biological resources and human genetic resources, preventing invasive species and preserving biodiversity, tackling drug resistant microbial infections, deterring bioterrorism, and other activities related to biosecurity. Experts called the law “foundational legislation” that will guide, coordinate and introduce new laws and regulations related to biosafety. China has nearly 100 pieces of legislation and regulation related to biosecurity, according to law firm King & Wood Mallesons. However, many of them are either outdated or are difficult to enforce. In February last year, President Xi Jinping said biosecurity is vital to people’s health and the longterm stability of the country, hence it should be included in the national security system. The law was passed in October.
This overview is based on reporting by the China Daily, Shanghai Daily and Global Times.
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