Why China doesn’t have an mRNA vaccine against Covid


China has done everything in its power to keep the virus outside its borders and protect its people — almost.

It has kept cases and deaths remarkably low through a “zero-Covid” strategy that has involved tracking and tracing every case, closing its borders and locking down cities of millions of people. He encouraged national vaccines which enabled the country to conduct a massive inoculation effort.

But two years into the pandemic, China’s 1.4 billion people still don’t have access to one of the world’s most effective coronavirus vaccines. These vaccines use revolutionary mRNA technology that was developed and approved in the West, and they have been adopted by dozens of countries.

The effectiveness of Chinese vaccines has been questioned, in part because they use a century-old inoculation method. Last spring, the country announced that it would approve BioNTech, the German mRNA vaccine made in partnership with Pfizer. Months later, China said it was also close to producing its own mRNA vaccine. Neither are available today.

China’s lack of mRNA – and its delay in approving a viable foreign option – has punched holes in Beijing’s pandemic victory story and prompted experts to question whether the stand-alone approach of the country is less triumphant than officials would have the world believe.

Under Xi Jinping, China’s top leader, the country has turned more inward, promoting self-reliance and championing development in areas such as semiconductors and other technologies. The delay in recognizing a foreign mRNA vaccine now appears to be part of this deeply political exercise.

China is so determined to compete with the United States and the West in science and technology that some in the scientific community say it’s hard to imagine the state doesn’t have everything implemented to develop an mRNA vaccine from home. The fact that China has fallen behind on this front and has not endorsed a readily available foreign option has left many pundits puzzled.

“We don’t know how decisions are made these days in China, but a better vaccine would definitely help maintain a zero-Covid policy,” said Jin Dongyan, a virologist at the University of Hong Kong, who urged his peers in mainland China. to approve the BioNTech vaccine.

“They are presenting to the world that they are doing well in vaccine development,” he said of officials in Beijing. “And it would be embarrassing for them to show the Chinese people otherwise.”

China says its virus policies, which include strict lockdowns, have prevented millions of people from getting sick. But as a result, scientists say, the population has not developed enough natural immunity to help fight off a serious infection, making reliable vaccines even more crucial. And pressure is slowly building on the country to adopt a new approach.

In recent months, officials have begun to openly discuss the need to introduce better vaccine technology. “We should learn more about good things in other countries, like mRNA vaccines,” Zhong Nanshan, China’s top respiratory scientist, said at a conference in December. “They spent years in research and managed to develop mRNA vaccines in just a few months.”

China last week approved for emergency use a Pfizer-made Covid-19 pill called Paxlovid, a move some experts say could help change Beijing’s pandemic strategy.

Not so long ago, China seemed ready to introduce an mRNA vaccine against Covid-19. Shanghai Fosun Pharmaceutical, BioNTech’s Chinese partner, told investors last year that regulators would approve its mRNA vaccine for use in China by July 2021. The company, which had conducted clinical trials in late 2020, said said it could manufacture up to a billion doses. a year.

This optimism has since faded. Chinese authorities now say they are still reviewing the documents to “make a final decision on whether to approve our vaccine,” a BioNTech spokeswoman said.

Fosun did not respond to a request for comment.

The approval process for Sinopharm and Sinovac – which make the vaccines available in China – was very different. Chinese regulators have changed rules to allow the two Chinese drugmakers to submit their trial data late. Sinopharm’s vaccine was approved a week after the company filed its application, in December 2020.

Vaccines from Sinovac and Sinopharm help prevent hospitalizations and deaths, but their ability to reduce transmission with variants such as Omicron is still in question. According to Brazilian scientists, Sinovac was found to be only 51% effective in preventing symptomatic disease. The World Health Organization has declared Sinopharm to be 78% effective.

Although the WHO has approved both Chinese vaccines for emergency use, most Western governments favor the mRNA technology.

As BioNTech’s approval languished, China said it was close to producing a local mRNA injection called ARCoVax. Two private drugmakers and the Chinese Academy of Military Medical Sciences said they were preparing to manufacture 200 million doses by October, a Communist Party newspaper reported in September.

If that had happened, it would have been a remarkable achievement for China.

Unlike traditional vaccines that use an inactivated virus to trigger an immune system response, mRNA vaccines use a genetic molecule that helps cells make proteins that can trigger an immune response in the body. This response creates antibodies which are then used to fight the virus.

The first mRNA vaccines against the coronavirus were based on research conducted for decades by scientists from different parts of the world. It took Western pharmaceutical companies Pfizer, BioNTech and Moderna just over a year to take these advances and apply them to a new type of vaccine capable of preventing serious illness and death from Covid-19.

The final version of mRNA vaccines produced by Pfizer and Moderna were made with the help of a multi-billion dollar program under the Trump administration called Operation Warp Speed. The Food and Drug Administration determined in 2020 that the BioNTech vaccine had a 95% effectiveness rate.

“It’s not a trivial technology,” said John P. Moore, virologist at Weill Cornell Medicine. “So trying to reverse engineer from scratch is one of those things where you’re like, ‘What could go wrong? “”

If China is pursuing a program similar to Operation Warp Speed, it hasn’t said anything publicly. One of the private companies contributing to the development of ARCoVax is Suzhou Abogen, a start-up founded in 2019 by a scientist who previously worked at Moderna. Before the pandemic, Abogen was developing mRNA-based drugs for cancer, one of China’s biggest epidemics.

The other drugmaker, Walvax, is a listed pharmaceutical company. The two companies’ partnership with the Chinese Academy of Military Medical Sciences suggests strong government support, although Beijing has not mentioned an official collaboration.

Last year, the United States added the Chinese Academy of Military Medical Sciences to an entity list, a federal list of trade restrictions, accusing it of using biotechnology to support activities such as “the brain control armament”. The designation would make it difficult to export any final vaccine product it develops.

Researchers recently released details of an initial trial of the ARCoVax vaccine involving 120 volunteers. They found it safe and said it produced a moderate level of antibodies but caused more side effects, such as fever, than the BioNTech vaccine.

Abogen and Walvax did not respond to requests for comment. A senior Walvax executive told Reuters last month that it had recruited 28,000 people for a large Phase 3 clinical trial. ARCoVax is also being tested as a booster.

A recent study showed that two doses of Sinovac boosted with an mRNA injection provided strong antibody protection against the Delta and Omicron variants. But it’s still unclear when the ARCoVax vaccine will be available in China.

And as the weeks go by, BioNTech’s endorsement seems to become more elusive.

“It’s very difficult to actually predict when we’ll get approval,” Sean Marett, chief commercial and commercial officer of BioNTech, said at a healthcare conference last month. “But China remains an extremely important market for us,” he added. “We are very, very attached to it.”

Cao Li contributed to the research.


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