Showing posts with label mRNA vaccine. Show all posts
Showing posts with label mRNA vaccine. Show all posts

Sunday, 22 January 2023

China’s bet on homegrown mRNA vaccines holds back nation

China is trying to navigate its biggest coronavirus outbreak without a tool it could have adopted many months ago, the kind of vaccines that have proven to offer the best protection against the worst outcomes from COVID-19.

May 25, 2022


China's first SARS-CoV-2 mRNA vaccine AWcorna, developed by Abogen Biosciences, Walvax Biotechnology, and the Academy of Military Medical Sciences' Institute of Biotechnology, is displayed at the National 13th Five-Year Scientific and Technological Innovation Achievement Exhibition in Beijing, China on Oct. 27, 2021. More than two years into the pandemic, China has not approved the more effective mRNA vaccines, instead choosing to pursue its own route on COVID-19 vaccines. (Chinatopix via AP)

As early as the spring of 2020 a Chinese pharmaceutical company, Fosun Pharma, reached an agreement to distribute — and eventually manufacture — the mRNA vaccine made by Pfizer and BioNTech. It still has not been cleared in mainland China, despite being authorized for use by separate authorities in Hong Kong and Macao.


Now health experts say that delay — a result of putting politics and national pride above public health — could lead to avoidable coronavirus deaths and deeper economic losses because whole cities would be locked down to insulate the country’s unprotected population.

“The biggest issue is about the delay of the reopening,” said Xi Chen, a health economist at Yale University’s School of Public Health. “The consequences will be huge, the supply chain disruption, the disruption to all kinds of service sectors.”

Studies have consistently shown that vaccination with mRNA vaccines made by Pfizer-BioNTech and Moderna offer the best protection against hospitalization and death from COVID-19. Chinese vaccines made with older technology proved fairly effective against the original strain of the virus, but much less so against more recent variants.

As this evidence became clearer, even countries that initially used Chinese vaccines and some other less effective Western-made vaccines have turned to mRNA vaccines for booster shots and new vaccinations.

Not China. Regulators have not publicly said why they have not acted — the mRNA vaccines are authorized in much of the world and have proven safe and effective in hundreds of millions of people. But a Chinese health official and another person directly involved in the negotiations told The Associated Press that authorities have held back because they want to master the technology in China and not depend on foreign suppliers. Both spoke on condition of anonymity, given the sensitive nature of the issue.

For more than a year, the approach seemed defensible. The country was able to keep the virus at bay better than any other large nation with its strict “zero COVID” approach that isolates infected people and locks down communities when infections pop up.

But now, the highly transmissible omicron variant is testing that strategy, requiring ever wider and longer lockdowns that are taking a greater economic and human toll. While other countries are able to operate close to normal because their people are protected by vaccination or previous infection, China is left with only its lockdown strategy to avoid huge numbers of hospitalizations and deaths.

China may be changing its mind. The Communist Party-owned Global Times newspaper reported last month that Fosun Pharma is still working with health authorities on its approval and Shanghai authorities recently issued new policies that could allow the import of COVID-19 vaccines. Fosun, based in Shanghai, did not respond to questions about the announcement.


China’s National Health Commission directed questions to the country’s drug regulator, the National Medical Products Administration. That agency did not respond to a faxed request for comment.

In the meantime, hopes for a Chinese-developed mRNA vaccine center on Abogen Biosciences, a startup founded in 2019 by Bo Ying, an American-trained scientist who once worked for Moderna.

The company has partnered with more established companies in the country such as Walvax, a private company founded in 2001, and the Academy of Military Medical Sciences, the military’s medical research facility. Abogen has raised more than $1.7 billion since 2020.

The company’s vaccine candidate succeeded in eliciting an immune response in a small, preliminary test in humans designed to evaluate safety, according to a study published in the journal Lancet Microbe.

The results were “promising,” said Dr. Vineeta Bal, who studies immune systems at the Indian Institute of Science Education and Research in Pune, India, although she said that a direct comparison of the immune response the shot triggered with the Pfizer and Moderna vaccines would have helped scientists better evaluate its performance.

But large studies that are needed to show whether the shot works to prevent infections or symptoms have not been completed. Abogen did not respond to requests for an interview.

Even if the studies can be completed and the vaccine proves effective, manufacturing the millions of doses required will be a challenge, experts say. Abogen built a manufacturing facility in December 2020 with a projected capacity of up to 120 million doses a year.

Manufacturing that vaccine and ensuring quality at scale will be a difficult hurdle to clear because mRNA is still a new technology, said Scott Wheelwright, chief operating officer at BioInno Bioscience, a Chinese biopharmaceutical contract manufacturer who has held conversations with Abogen.

In the meantime, Chen, the Yale health policy expert, said the Chinese government should better protect its elderly population by both approving the Pfizer vaccine and encouraging booster shots.

Using a Chinese phrase that means “giving up completely,” Chen said the change from “zero COVID” does not have to be all or nothing. “It doesn’t have to be tang ping or sticking to zero COVID,” Chen said. “I don’t think there are only two solutions, and we can stick to a middle ground.”

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Ghosal reported from New Delhi. Associated Press journalist Dake Kang in Beijing contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


https://apnews.com/article/covid-science-technology-health-00e7e5ebf9460bad115b491009b58bef

Thursday, 8 September 2022

These Vaccines Have Been Embraced by the World. Why Not in China?

 Beijing once said it had two mRNA shots within reach and ready for approval — one homemade and one produced by a foreign company. Today, neither is available.

Why China Doesn’t Have an mRNA Vaccine for Covid - The New York Times (nytimes.com)

Credit...Kevin Frayer/Getty Images

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, closed its borders and locked down cities of millions of people. It fostered domestic vaccines that allowed the country to carry out 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 most effective coronavirus vaccines the world has to offer. Those vaccines use the breakthrough mRNA technology that was developed and approved in the West, and they have been embraced by dozens of countries.

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

China’s lack of an mRNA shot — and its delay in approving a viable foreign option — has poked holes in Beijing’s victorious pandemic narrative and prompted experts to question whether the country’s go-it-alone approach 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 like semiconductors and other technology. The delay in recognizing a foreign mRNA vaccine now appears to be a part of that deeply political exercise.

Image
Sinopharm and Sinovac, which manufacture the two vaccines available in China, do not use mRNA technology. The country’s resistance to approving a foreign mRNA vaccine appears to be part of its inward turn.
Credit...Ng Han Guan/Associated Press

China is so committed to competing with the United States and the West on science and technology that some in the scientific community say it is hard to imagine that the state hasn’t pulled out all the stops to develop a homegrown mRNA vaccine. That China has fallen behind on that front, and failed to approve a readily available foreign option, has left many experts baffled.
“We don’t know how decisions are made nowadays in China, but a better vaccine would definitely help in maintaining a zero-Covid policy,” said Jin Dongyan, a virologist at the University of Hong Kong who has 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 opposite to the Chinese people.”

More on China
A ‘Zero Covid’ Bind: Political considerations have driven China’s uncompromising approach to lockdowns, quarantines and mass testing. That has left officials little room to change course.
Communist Cadre Look: Why are some Chinese youth dressing like middle-aged civil servants? It might be ironic, or the expression of a longing for stability in uncertain times.
Controlling the Narrative: As cases of abuse against women trigger outrage across China, Chinese officials are trying to censor the online conversation, wary of any dissent they cannot control.
A Long-Awaited Report: The United Nations released its much-delayed assessment of the mass detention of Uyghurs and other Muslim groups in China, accusing the country’s leadership of human rights violations.

China says its virus policies, which include strict lockdowns, have prevented millions of people from getting sick. But as a consequence, scientists say, the population has not built up enough natural immunity to help fight severe infection, making reliable vaccines even more crucial. And there is slowly mounting pressure on the country to pursue a new approach.
In recent months, officials have begun openly discussing the need to introduce better vaccine technology. “We should learn about the good things in other countries, such as mRNA vaccines,” Zhong Nanshan, China’s top respiratory scientist, said at a conference in December. “They have spent years on the research and managed to develop mRNA vaccines in just a few months."
China last week approved for emergency use a Covid-19 pill made by Pfizer called Paxlovid, a move that some experts said could help change Beijing’s pandemic strategy.
Image
The National Vaccine and Serum Institute in Beijing. The winds in China may be shifting as some officials begin to openly discuss the need to embrace better vaccine technology in the pandemic.
Credit...Roman Pilipey/EPA, via Shutterstock

It wasn’t that long ago that China appeared 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 by July 2021. The company, which had conducted clinical trials in late 2020, said that it could make as many as a billion doses a year.
That optimism has since faded. Chinese authorities now say they are still reviewing documents in order to “make a final decision on the approval of our vaccine,” a spokeswoman for BioNTech said.
Fosun did not respond to a request for comment.
The approval process for Sinopharm and Sinovac — which manufacture the vaccines that are available in China — looked much different. Chinese regulators changed the rules to allow both Chinese drugmakers to submit their trial data behind schedule. Sinopharm’s vaccine was approved a week after the company filed its application, in December 2020.
Vaccines from Sinovac and Sinopharm help prevent hospitalization and death, but their ability to reduce transmission with variants such as Omicron is still in question. Sinovac has shown to be only 51 percent effective against preventing symptomatic disease, according to scientists in Brazil. The World Health Organization said Sinopharm has an efficacy of 78 percent.
Though the W.H.O. has signed off on both Chinese vaccines for emergency use, most Western governments favor mRNA technology.
Image
The production of the Sinopharm vaccine. Two private drugmakers in China are working on an mRNA vaccine, but have fallen behind on their promises to deliver.
Credit...Kevin Frayer/Getty Images

As approval for BioNTech languished, China said that it was close to producing a homegrown mRNA shot called ARCoVax. Two private drugmakers and China’s Academy of Military Medical Sciences said they were preparing to make 200 million doses by October, a Communist Party newspaper reported in September.
Had that happened, it would have been a remarkable achievement for China.
Unlike traditional vaccines that use an inactivated virus to trigger a response by the immune system, mRNA vaccines use a genetic molecule that assists cells to make proteins that can set off an immune response in the body. This response creates antibodies that are then used to fight the virus.
The first mRNA vaccines for the coronavirus were based on research conducted over decades by scientists in different parts of the world. It took the Western pharmaceutical companies Pfizer, BioNTech and Moderna just over a year to take those advances and apply them to a new kind of vaccine able to prevent serious illness and death from Covid-19.
The final version of the mRNA vaccines produced by Pfizer and Moderna came together 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 percent.
“This is not 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 possibly go wrong?’”
If China is pursing a program similar to Operation Warp Speed, it has not said anything about it publicly. One of the private companies helping to develop ARCoVax is Suzhou Abogen, a start-up founded in 2019 by a scientist who used to work at Moderna. Before the pandemic, Abogen was developing mRNA drugs for cancer, one of China’s biggest epidemics.
Image
Students received the Sinopharm vaccine at a high school in Shenyang, China, earlier this year.
Credit...Agence France-Presse — Getty Images

The other drugmaker, Walvax, is a publicly listed pharmaceutical group. The two companies’ partnership with the Chinese Academy of Military Medical Sciences suggests strong government backing, though 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 trade restriction list, accusing it of using biotechnology to support activities like “brain control weaponry.” The designation would make it difficult to export any final vaccine product it develops.
Researchers recently published the details of an initial trial of the ARCoVax vaccine involving 120 volunteers. They found it to be safe, and said it produced a moderate level of antibodies but caused more side effects, like fever, than the BioNTech shot. 
Abogen and Walvax did not respond to requests for comment. A senior executive at Walvax 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.
One recent study showed that two doses of Sinovac boosted with an mRNA shot offered strong antibody protection against both the 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 to grow more elusive.
“It’s very difficult to predict actually when we will get approval,” said Sean Marett, chief business and commercial officer of BioNTech, speaking at a health care conference last month. “But China remains for us an extremely important market,” he added. “We’re very, very committed to it.”
Image
The Shanghai Fosun Pharmaceutical building in Shanghai. Fosun, BioNTech’s Chinese partner, told investors last year that regulators would approve its mRNA vaccine for use in China by July 2021.
Credit...Alex Plavevski/EPA, via Shutterstock

Cao Li contributed research.

Alexandra Stevenson is a business correspondent based in Hong Kong, covering Chinese corporate giants, the changing landscape for multinational companies and China’s growing economic and financial influence in Asia. @jotted  Facebook

A version of this article appears in print on Feb. 21, 2022, Section B, Page 1 of the New York edition with the headline: China Lacks Effective Shot, But Rejects Foreign OptionsOrder Reprints | Today’s Paper | Subscribe

Why China Doesn’t Have an mRNA Vaccine for Covid - The New York Times (nytimes.com)

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