Despite rapidly developing and rolling out two vaccines against COVID-19 – from domestic firms Sinopharm and Sinovac – China is yet to approve a vaccine that uses mRNA technology, either from a domestic firm or one of the two international products (Pfizer/BioNTech and Moderna) currently approved elsewhere.
As the country faces its worst COVID outbreak in two years, with 51 million people under strict lockdowns and the Sinopharm/Sinovac products seemingly less effective against the prevalent Omicron variant, commentators are asking why mRNA vaccines – which could be a route out of this outbreak – remain unavailable in China.
The Case for mRNA
As Reuters reports, the Pfizer/BioNTech and Moderna vaccines have shown better efficacy in preventing symptomatic cases than the most-used Chinese shots based on other technologies in pre-Omicron clinical trials. The inactive Chinese vaccines have both proven to be highly effective at preventing severe infection or death from COVID, but remain less effective than mRNA vaccines overall.
Hong Kong – currently undergoing a COVID surge of its own – has approved both the Sinovac and Pfizer/BioNTech vaccines and could provide more evidence of mRNA’s greater effectiveness against Omicron. A Hong Kong newspaper, Ming Pao, reported that 87 percent of the vaccinated who died in Hong Kong had been vaccinated with Sinovac’s CoronaVac vaccine, suggesting that the Pfizer/BioNTech mRNA vaccine provided more protection.
However, even those vaccinated with non-mRNA vaccines showed far higher survival rates than the unvaccinated, who have been shown to be 30 times more likely to die than the vaccinated in Hong Kong.
One explanation as to why no mRNA vaccine has yet been approved in mainland China is geopolitical. Given the ongoing tensions with the West – and especially the US – China is perhaps prioritising using locally developed vaccines over foreign ones in its own population. However, China has as yet been unable to develop a safe and effective mRNA vaccine.
As the New York Times’ Alexandra Stevenson writes, “Under Xi Jinping, China’s top leader, the country has turned more inward, promoting self-reliance and championing development in areas like semiconductors and other technology. The delay in recognizing a foreign mRNA vaccine now appears to be a part of that deeply political exercise.”
One of the country’s leading pharma companies, Fosun Pharmaceuticals, has a license to manufacture and distribute BioNTech’s vaccine in China and has submitted clinical data to the Chinese regulator, but progress has since stalled. Nevertheless, the fact that a COVID-19 treatment – Pfizer’s Paxlovid – has recently achieved regulatory approval in China may signal an increased openness on the part of the Chinese authorities to foreign COVID-related products.
Of course, China would prefer to bring its own mRNA vaccine to market. The leading candidate is known as ‘ARCoV’ and has been developed by Suzhou Abogen and Walvax in collaboration with the Chinese Academy of Military Medical Sciences (AMMS). Unlike the Pfizer/BioNTech and Moderna vaccines, which instruct the human body to produce antigens mimicking the coronavirus’ spike protein, ARCoV targets one specific part of the protein.
Additionally, ARCoV’s developers claim that it can remain stable at between two and eight degrees Celsius for six months, a better profile than Pfizer/BioNTech (one month) and Moderna (up to three), and a potential selling point if the product ever finds its way to patients in China or abroad.
The potential internationalisation of ARCoV would however be hamstrung by the addition of AMMS to a US federal trade restriction list in 2021, restricting its access to US exports. ARCoV is currently undergoing Phase III clinical trials in China, Mexico, India, and Nepal.
Other Chinese mRNA vaccine candidates, some of which are specifically targeting the Omicron variant include those from Stemirna Therapeutics, Guangzhou RiboBio, AIM Vaccine, RNACure/Walvax, Sinopharm/CanSino Biologics, and Sinopharm unit China National Biotec Group.