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Why China doesn’t have an mRNA vaccine for Covid

China has done everything in its power to contain the virus beyond its borders and protect its people – almost.

It has kept cases and deaths remarkably low through a “zero-Covid” strategy that includes tracking and tracing every case, closing borders and locking down cities with millions of people. . It promotes domestic vaccines that allow the country to make a big transplant effort.

But two years after the pandemic, China’s 1.4 billion people still do not have access to one of the most effective coronavirus vaccines the world has to offer. These vaccines use groundbreaking mRNA technology that has been developed and approved in the West, and they have been adopted by dozens of countries.

Effectiveness of Chinese vaccine in doubt – in part because they use a centuries-old method of transplanting. Last spring, the country said it would approve BioNTech, the German mRNA production company made in partnership with Pfizer. Months later, China said it was also close to producing its own mRNA vaccine. Both are not present today.

China’s lack of mRNA – and the delay in approving a viable foreign option – has punctured a hole in Beijing’s pandemic victory story and led experts to question whether its approach of the country alone is less successful than officials the world believes or not.

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 recognition of foreign mRNA vaccines now appears to be part of that deeply political activism.

China is so committed to competing with the United States and the West in science and technology, that some in the scientific community say it is hard to imagine that the state has not found all the way to homegrown mRNA vaccine development. China’s lagging behind on that front, and not adopting an available foreign option, has puzzled many experts.

“We don’t know how decisions are made today in China,” said Jin Dongyan, a virologist at the University of Hong Kong who urged his colleagues in mainland China. , but a better vaccine will certainly help maintain the zero-Covid policy. approval of the BioNTech vaccine.

“They are showing the world that they are doing a great job in developing a vaccine,” he said of officials in Beijing. “And it would be a shame for them to show the opposite to the Chinese.”

China speak Its virus policies, including strict lockdowns, have prevented millions of people from getting sick. But as a result, the scientists say, populations have not built enough natural immunity to help fight off severe infections, making reliable vaccines all the more important. And gradually increasing pressure forces the country to pursue a new approach.

In recent months, officials have begun to openly discuss the need to introduce better vaccine technology. Zhong Nanshan, China’s top respiratory scientist, “We should learn about the good things in other countries, such as the mRNA vaccine,” speak at a conference in December. “They’ve spent years researching and figuring out how to develop an mRNA vaccine in just a few months.”

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

Not long ago, China was ready to introduce an mRNA vaccine for Covid-19. Shanghai Fosun Pharmaceutical, BioNTech’s Chinese partner, told investors last year that regulators would approve its mRNA vaccine for use in China in July 2021. The company has already made progress. running clinical trials by the end of 2020, says they can make up to a billion doses a year.

That optimism also faded from there. Chinese authorities say they are still reviewing the documents to “make a final decision on approving our vaccine”, a BioNTech spokesman said.

Fosun did not respond to a request for comment.

The approval process for Sinopharm and Sinovac – which makes vaccines available in China – looks much different. Chinese regulators have changed the rules to allow Chinese drugmakers to submit their trial data later than planned. Sinopharm’s vaccine was approved a week after the company submit it application, in December 2020.

Vaccines from Sinovac and Sinopharm help prevent hospitalizations and deaths, but their ability to reduce transmission with variants like Omicron is still in doubt. Sinovac Scientists in Brazil found it to be only 51% effective in preventing symptomatic diseases. The Universal Health Organization said Sinopharm effective is 78 percent.

Although WHO has contracted both vaccines from China for emergency use, most Western governments are in favor of mRNA technology.

Once the approval for BioNTech ran out, China said it was close to producing a home-grown mRNA called ARCoVax. Two private drugmakers and the Chinese Academy of Military Medical Sciences say they are preparing to produce 200 million doses of the drug by October, a Communist Party newspaper said. report in September.

If that happens, it will be a significant achievement for China.

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

The first mRNA vaccines for coronavirus were based on research carried out over several decades by scientists in different parts of the world. It took Western pharmaceutical companies Pfizer, BioNTech and Moderna just over a year to take those advances and apply them to a new vaccine that could prevent serious illness and death from Covid-19.

The The final version The mRNA vaccine is manufactured by Pfizer and Moderna with the help of a multibillion-dollar program under the Trump administration called Operation Warp Speed. The Food and Drug Administration determined in 2020 that the BioNTech vaccine has an efficacy rate of 95%.

“This is no trivial technology,” said John P. Moore, a virologist at Weill Cornell Medicine. “So trying to reverse engineer it from scratch is one of those things where you ask, ‘What could happen?’

If China was pursuing a program similar to Operation Warp Speed, they would not have made anything public about it. One of the private companies helping to develop ARCoVax is Suzhou Abogen, a startup founded in 2019 by a scientist who used to work at Moderna. Before the pandemic, Abogen was developing an mRNA drug for cancer, one of China’s biggest epidemics.

The other drugmaker, Walvax, is a publicly listed pharmaceutical corporation. The two companies’ partnership with the Chinese Academy of Military Medical Sciences shows strong government backing, although Beijing has yet to mention an official collaboration.

Last year, the US added the Chinese Academy of Military Medical Sciences to a entity list, a federal trade restriction list, alleges it uses biotechnology to support activities such as “brain-controlled weapons”. This designation would make it difficult to export any final vaccine products it develops.

Recent researchers published details of the initial trial of the ARCoVax vaccine with the participation of 120 volunteers. They found it safe and said it produced a moderate amount of antibodies but caused more side effects, such as fever, than injections of BioNTech.

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

A recent study shows that two doses of Sinovac enhanced with a single injection of mRNA provided robust antibody protection against both Delta and Omicron variants. But it is still unclear when the ARCoVax vaccine will be available in China.

And as the weeks go by, approval for BioNTech seems increasingly elusive.

“It is really difficult to predict when we will be approved,” speak Sean Marett, BioNTech’s director of sales and commerce, speaking at a healthcare conference last month. “But for us, China is still a hugely important market,” he added. “We’re very, very committed to it.”

Cao Li research contributions.

https://www.nytimes.com/2022/02/18/business/china-coronavirus-vaccines.html Why China doesn’t have an mRNA vaccine for Covid

Fry Electronics Team

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