Moderna refused China request to reveal vaccine technology

 Moderna has refused to hand over to China the core intellectual property behind the development of its breakthrough Covid-19 vaccine, leading to a collapse in negotiations on its sale there, according to multiple people familiar with the matter. 

Sun Yu in New York, Eleanor Olcott in Hong Kong and Donato Paolo Mancini in London OCTOBER 2 2022 

The mRNA vaccine technology used by Moderna provides longer-lasting and higher levels of protection than tech used by Chinese providers © FT montage: AFP/Getty Images

 Moderna has refused to hand over to China the core intellectual property behind the development of its breakthrough Covid-19 vaccine, leading to a collapse in negotiations on its sale there, according to multiple people familiar with the matter. 

 The Massachusetts-based pharmaceutical company turned down Beijing’s request to hand over the recipe for its messenger RNA vaccine because of commercial and safety concerns, said two people involved in negotiations that took place between 2020 and 2021. 

The vaccine maker says it is still “eager” to sell the product to China. The mRNA vaccine technology used by Moderna and BioNTech/Pfizer provides longer-lasting and higher levels of protection than the inactivated vaccine technology used by Chinese makers. 

Several Chinese pharma companies are racing to develop a homemade mRNA alternative but have struggled with the emergence of more infectious variants. 

 One individual close to the Moderna team in Greater China said the company had “given up” on its previous efforts to access the Chinese market, because of Beijing’s demand that it hand over the technology as a prerequisite for selling into the country. 

 To date, Beijing has offered two routes for foreign Covid-19 vaccine makers to distribute in China, dependent on regulatory approval: carrying out a full technology transfer to a domestic drugmaker or establishing a manufacturing facility in China with a local partner, while keeping control of the underlying technology. 

Moderna was pressed to take the former option. 

 The German group BioNTech has struck a deal with Shanghai Fosun Pharmaceutical to conduct clinical trials and commercialise its vaccine in 2020, which meant it retained control of the intellectual property. 

Under the partnership, Fosun agreed to provide a factory that would make up to 1bn doses a year. 

 By contrast, the Shanghai-based Everest Medicines group made a deal to access the Canadian biotech company Providence Therapeutics’s mRNA vaccine candidate that involved a full tech transfer. 

 Beijing has not granted either vaccine regulatory approval. 

 The Moderna leadership did not want to hand over the vaccine recipe to a Chinese partner because of the reputational damage if the local partner botched the manufacturing, said two people with knowledge of the matter. 

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 Moderna has been fiercely protective of its intellectual property around the world, saying handing over patents would do little to address supply constraints. Talks in Italy for a tech transfer to local manufacturing sites have also failed, but Moderna gave the reason that it lacked the capacity to oversee it. 

 China has not approved any mRNA products for therapeutic purposes, and the mass production of this kind of vaccine is more complex than China’s existing inactivated vaccines made by Sinopharm and Sinovac. 

 In recent weeks, Moderna has signalled a willingness to restart talks with China. Its chief medical officer Paul Burton said this month: “We would certainly be very eager to collaborate with China if they felt that there was a need for a vaccine there.” 

 Burton’s comments came days after US president Joe Biden proclaimed the “pandemic is over”, wiping more than $10bn off the market value of the main makers of vaccines, including Moderna. 

 Moderna told the Financial Times: “We are not currently engaged in supply talks with China. We are open to speaking with countries on their supply needs for Covid-19 vaccines.” 

 Industry insiders observed that the company’s willingness to reopen talks with China, the last remaining major economy without an mRNA jab, has been driven by sluggish demand for vaccines in the wealthier countries where it first targeted sales. 

 According to Airfinity, a data firm that monitors vaccine shipments, Moderna has shipped a greater share of its vaccines to high-income countries than the other three major vaccine makers, a strategy that earned it billions of dollars in profit. 

More than 86 per cent of Moderna’s jabs have been delivered to high-income countries, compared with 74 per cent for BioNTech/Pfizer, 63 per cent for Johnson & Johnson and 19 per cent for AstraZeneca. 

 Slowing demand has afflicted all the major coronavirus vaccine makers, but with the Covid-19 jab its only approved product, the pressure on Moderna’s management is particularly acute, according to people familiar with the matter. 

 Additional reporting by Jamie Smyth in New York

https://www.ft.com/content/a481c129-c5aa-4972-84a8-3a45bb000098

China's Covid-19 vaccine push falters as nations switch to mRNA shots

PUBLISHED  

SEP 30, 2021, 6:33 AM SGT  (This article is 8 mths old)

Many governments that once relied on Chinese shots are now ordering or seeking donations of mRNA vaccines instead. PHOTO: AFP

BEIJING (BLOOMBERG) - In the early days of the Covid-19 vaccine rollout, Chinese shots saved countless lives. They kick-started inoculation programmes across Asia, Latin America and the Middle East, while richer countries hoarded scarce mRNA shots from Pfizer and Moderna.

But many governments that once relied on vaccines from Sinovac Biotech or Sinopharm Group are now turning to options from the United States and Europe instead, as concerns mount about Chinese vaccines' efficacy against the Delta strain and the Western stranglehold on mRNA supplies grows looser.

That preference may already be showing up in China's customs data, where exports of human vaccines dropped 21 per cent in August to US$1.96 billion from US$2.48 billion in July, after rising steadily since December 2020.

"Basically people took what they could get" when Covid-19 vaccines first became available, said Nicholas Thomas, an associate professor at the City University of Hong Kong who has edited several books on foreign policy and public health.

"But as this has gone on, general populations - rather than just medical practitioners - have become more educated about the differences," he said. "They have realised that not all vaccines are equal in terms of protection."

This shift played out during Thailand's deadly outbreak earlier this year. As cases surged and South-east Asia emerged as the new epicentre of the pandemic, the nation desperately tried to purchase vaccines. Only one supplier came through in time: China's Sinovac.

The shots allowed the country of 70 million to begin its inoculation campaign earlier than hoped, but Thailand soon confronted a challenge now faced by lawmakers across the developing world.

The efficacy of China's inactivated vaccines ranges from about 50 per cent to 80 per cent in clinical trials. But they are less potent than mRNA vaccines and questions are mounting about their effectiveness against the highly transmissible Delta variant.

As a result, the Thai government became the first in the world to offer an AstraZeneca shot to people who had already received a jab or even two of Sinovac. While it is not an mRNA, Thai studies showed the Cambridge, UK-based company's viral vector vaccine is potent as a booster to the Chinese shot, and that Pfizer's dose was found to be even more effective.

But many Thais soon expressed a strong preference for Western shots - even protesting to demand them - and the country's opposition began lambasting the government for its reliance on China. Thailand halted orders of Sinovac and began buying more Western vaccines.

I'm not anti-Sinovac," said Chaowat Sittisak, a 29-year-old teacher in northern Thailand who got a first dose of Sinovac but ordered a second Moderna shot from a private hospital. "If the world only had one vaccine and it's Sinovac, I'd get it. But we have so many other choices. And I want whatever is best."

Many governments that once relied on Chinese shots are now ordering or seeking donations of mRNA vaccines instead. The swing away from China is likely to accelerate as US President Joe Biden promises to donate 1.1 billion mRNA shots, Europe pledges hundreds of millions of vaccines and India prepares to once again export AstraZeneca vaccines after curtailing shipments following its deadly second wave.

In addition to availability and efficacy, freedom of movement may also be motivating the shift: Recipients of Chinese vaccines cannot travel to some locations.

Vaccine exports

In a written reply to Bloomberg, Sinovac said its CoronaVac shot has been effective at preventing hospitalisation, intensive care admissions and deaths throughout the pandemic.

A spokesperson said some countries first rolled out Sinovac to the elderly, who are more likely to be hospitalised with Covid-19, while younger populations received different vaccines later, "and this should be factored in the evaluation of CoronaVac's effectiveness".

Many countries, including Thailand, have "purchased vaccines from multiple suppliers in order to maximise the number of doses available for their population," the company said.

As things stand, the list of places shifting away from Chinese vaccines - or augmenting them with Western boosters - includes Turkey and the United Arab Emirates. In China's own territory of Hong Kong, which has long offered residents a choice between BioNTech and Sinovac, health officials are now testing whether the Chinese shot will perform better when paired with a western booster.

While Sinovac allowed Thailand to start its rollout earlier than planned, the 6 million doses arriving in October will be the last shipment. In 2022, at least three quarters of the government's orders will also come from Astra and Pfizer.

Moves like Thailand's represent a blow to China's vaccine diplomacy ambitions. Nevertheless, governments face a tricky balance between wanting to protect the public and maintaining good relations with China.

The Thai Health Ministry has been careful to say that while it has no plans to order more Sinovac, it is not suggesting the shots are not effective. Chinese firms have exported some 884 million doses of its homegrown vaccines via mostly bilateral deals with places like Brazil and Indonesia.

This week, Chile started giving Sinovac shots to children as young as six, a strong endorsement of a shot that's formed the backbone of their rollout.

And there are still many parts of the world drastically short of vaccines. Some African nations, for instance, have barely started their inoculation drives after struggling to procure shots.

Cote d'Ivoire, Burkina Faso and Kenya are all rolling out Chinese vacciness, and Beijing is a key supplier to the World Health Organisation-backed Covax facility aimed at getting vaccines to the developing world. President Xi Jinping has pledged to export 2 billion doses this year, matching commitments by Group of Seven nations.

Various studies conducted around the world have shown the jabs to be effective at preventing serious illness and death. Yet China's pharmaceutical firms - which were initially less forthcoming than western companies in releasing clinical trial data - have not released similarly conclusive studies that inactivated vaccines are effective against the Delta.

Over the coming year, policymakers may well continue turning away from the older technology of the inactivated Chinese vaccines, says Benjamin Cowling, a professor of epidemiology and biostatistics at the University of Hong Kong, who published a recent study in the Lancet showing the Pfizer vaccine generated 10 times more antibodies than Sinovac.

"If you've got some vaccines that are more effective than others, and the cost is roughly the same, then you're going to get a better bang for the buck if you choose the more effective vaccines," Cowling said. "But I still think that the supplies are limited, so it may not be as easy as saying, 'We just want to order the Moderna vaccine,' or whatever."

'Better alternatives'

In Thailand, the opposition Move Forward party is now calling on the government to reveal the percentage of people who have only received the Sinovac shots.

"The government already knows that studies and research show inactivated virus vaccines are less effective against virus mutations when compared to mRNA-based vaccines," said Wiroj Lakkhanaadisorn, an opposition lawmaker and a key critic of the government's vaccine policies. "We should know the vaccination rate that excludes all two-dose Sinovac shots because the immunity may not be enough any more. Any regions that are ready can then reopen."

Thailand's health ministry didn't respond to a request for comment.

Chaowat, the teacher, said he felt pressured to take the Sinovac shot because of his job but is hoping to get a Moderna shot in a month or two.

"The government is turning away from Sinovac because they have to push through with their reopening plan and they want to reduce vaccine hesitancy among people who don't want Sinovac," he said. "They're turning to better alternatives."

Source: https://www.straitstimes.com/asia/east-asia/chinas-covid-19-vaccine-push-falters-as-nations-switch-to-mrna-shots

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China's bet on homegrown mRNA vaccines holds back nation

 TAIPEI, Taiwan (AP) — 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.

24 May 2022

By HUIZHONG WU and ANIRUDDHA GHOSAL   AP

© Provided by Associated Press 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.

© Provided by Associated Press Visitors look at giant replica bottles of COVID-19 vaccine including one produced via mRNA technology by Sinopharm subsidiary CNBG at the China International Fair for Trade in Services (CIFTIS) in Beijing, China on Sept. 5, 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. (AP Photo/Ng Han Guan)

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.

© Provided by Associated Press Visitors look at giant replica bottles of COVID-19 vaccine including ones produced via mRNA technology by Sinopharm subsidiary CNBG at the China International Fair for Trade in Services (CIFTIS) in Beijing, China on Sept. 5, 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. (AP Photo/Ng Han Guan)

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.”

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

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China’s Biggest Covid Failure Is Not Deploying an mRNA Vaccine

 Beijing refuses to allow Western shots even though development of homegrown ones lags.

Bloomberg Businessweek

April 27, 2022, 4:00 AM GMT+8

Covid vaccination at a mobile site in Beijing on April 9.Photographer: Chen Zhonghao/Xinhua News Agency/eyevine/Redux

 Weeks into a Covid-19 outbreak in Shanghai that brought China’s financial hub to a standstill, the government of President Xi Jinping has demonstrated its willing to go to extremes in its quest to contain the virus. One thing Xi has so far been unwilling to do is deploy a powerful tool against the highly contagious omicron variant: mRNA vaccines. Those shots could reduce the chances of elderly and other vulnerable Chinese getting seriously ill or dying—and possibly help the country transition away from its “Covid Zero” stance.

Lining up the necessary supplies shouldn’t be hard because Shanghai Fosun Pharmaceutical Group Co. in March 2020 agreed to buy a stake of 0.7% in BioNTech SE and to market the mRNA vaccine the German company co-developed with Pfizer Inc. in China. Before the close of that same year, the two companies had arrived at a plan to distribute 100 million doses in China, once they got the green light from the government. Yet the drug regulator has yet to grant approval.

“Worldwide data clearly indicates mRNA is the gold standard,” says Joerg Wuttke, president of the European Union Chamber of Commerce in China, which wrote to the Chinese government in April urging it to allow the shots. “Why waste time and wait, for what?”

Share of Population Fully Vaccinated Against Covid-19

As of April 24

Source: Compiled by Bloomberg

The wait, many analysts believe, is for a local company to come up with its own mRNA vaccine. Since the start of the pandemic, Xi’s government has touted self-reliance in fighting Covid, promoting domestic vaccines based on inactivated versions of the virus and barring all foreign ones from the market. Slightly more than 88% of China’s 1.4 billion people have received two doses of those shots.

Opening up to foreign-made mRNA shots risks embarrassing Xi and other officials, says Allison Hills, senior consultant in London with Eradigm Consulting, which advises biotech and pharmaceutical clients. “For them to say now we are accepting BioNTech,” she says, “it’s tantamount to saying ours are not as good.”

Clinical trials have shown the inactivated vaccines from China’s Sinopharm Group Co. and Sinovac Biotech Ltd. to be less effective in stopping infections, though the gap in protecting against severe disease and death is narrower.

Last year, optimists hoped China’s go-it-alone strategy would lead to the speedy approval of a locally made mRNA vaccine, co-developed by Walvax Biotechnology Co., Suzhou Abogen Bioscience Co., and the Academy of Military Medical Sciences. Upbeat about their chances, the partners invested in a new facility to ramp up production once Beijing gave the green light, with state media reporting production would start by August 2021. However, results of early trials were disappointing and the vaccine is unlikely to reach the market before the end of 2022, according to Bloomberg Intelligence.

An exhibitor shows two packets of an mRNA vaccine co-developed by Walvax Biotechnology at the China International Technology Fair in Shanghai in April 2021.

Photographer: FeatureChina/AP Photo

One reason for the delay could be the different approach the Walvax group took. Unlike the shots from Pfizer-BioNTech and Moderna Inc., the Chinese vaccine targets a part of the coronavirus spike protein that binds to cells in the body, according to Sam Fazeli, senior pharmaceutical analyst with Bloomberg Intelligence in London. For vaccine developers, focusing on this smaller area, called the receptor binding domain, can reduce costs and may facilitate manufacturing. It can also add uncertainty, given that this particular domain is a focal point for mutations in newer variants.

“Walvax’s problem is the majority of the mutations with omicron are in that receptor binding domain,” says Fazeli. “The risk is that their vaccine’s efficacy is likely to be much more compromised compared to other vaccines.”

Walvax, which didn’t respond to a request for comment regarding the design of the mRNA vaccine it co-developed with Abogen, says it has partnered with a Shanghai-based biotech startup called RNACure Biopharma to develop another mRNA vaccine targeting variants, including omicron. This one encodes a full-length spike protein that covers major mutations from variants. The companies are seeking approvals to begin human testing.

Walvax’s difficulties have raised the stakes for other Chinese companies working on vaccines using the same technology. In early April, China gave permission for CanSino Biologics Inc. and CSPC Pharmaceutical Group Ltd. to each begin first-phase trials for their mRNA shots.

Other drugmakers are further along: Shanghai-based Stemirna Therapeutics Co. has tested an mRNA candidate in Laos and plans further testing in Brazil. It hopes to get emergency-use approval in Southeast Asia and South America. Beijing-based AIM Vaccine Co., which has a Phase 2 trial of its mRNA vaccine under way in China, expects to apply for conditional approval by the end of the year, according to spokesperson Lingna Ding.

Read more: China Crushed Covid. But Covid Zero Could Crush China

Early data from Hong Kong’s winter omicron wave show why mRNA vaccines could be valuable in China. A preprint study by researchers at the University of Hong Kong in late March concluded that two doses of the Sinovac vaccine underperformed BioNTech’s shots, especially among the elderly. For prevention of severe disease, BioNTech’s vaccine effectiveness in people 80 and older was 84.5%, compared with just 60.2% for Sinovac; for protection against death, there was a gap of about 20 percentage points, with BioNTech at 88.2% and Sinovac at 66.8%.

The study, which was funded by the Chinese government, found no significant gap for those who had received three doses. That cohort, however, was small, as only about 10% of seniors had received boosters and government vaccination teams dispatched to nursing homes—sites of the worst outbreaks—only offered Sinovac shots.

Another study by Hong Kong researchers, published in January in the journal Nature, concluded that governments primarily using Sinovac’s vaccines should consider mRNA vaccine boosters in response to the spread of omicron.

Given the strong performance of mRNA vaccines, providing them as boosters should help people who have received two doses of Chinese shots, says Jyoti Somani, senior consultant for the Division of Infectious Diseases at National University Hospital in Singapore, where the government has approved China’s inactivated-virus vaccines as well as mRNA shots developed elsewhere. “It looks like you are getting a much broader immune response when you mix and match,” she says. “What is clear is that we need both.”

That argument is winning support inside China. Zhong Nanshan, a pulmonologist and influential government adviser on Covid, in March co-authored a road map for China’s reopening that identified better booster coverage, with different vaccine types, as essential. Ding Sheng, dean of Tsinghua University’s School of Pharmaceutical Sciences, in March said that existing Chinese vaccines weren’t protective enough against omicron and that the government should encourage companies to introduce more effective shots.

Fosun’s chief executive officer, Wu Yifang, told reporters at a briefing on March 23 that China’s drug regulator is still weighing whether to approve the BioNTech shot. Authorities in February gave the green light to Pfizer’s antiviral treatment, Paxlovid, filling a need because Chinese drugmakers don’t have any antivirals of their own. In the same way, regulators might eventually lose patience with Chinese vaccine makers and open the door to BioNTech’s shots.

With no mRNA vaccines of any kind on the horizon, Chinese health officials may have to focus on better deploying the shots now available, targeting vaccine holdouts, especially among seniors, and improving booster rates. Approximately half the population has received booster shots. That compares with about 30% in the U.S. “Any of the vaccines would be a good thing,” says Colin Pouton, a professor at the Monash Institute of Pharmaceutical Sciences in Melbourne.

The Covid Zero policy is making that more difficult, with millions of residents stuck in their homes in Shanghai and other cities. “We have economic damage, we have social tension, we have basically a whack-a-mole outlook,” says Wuttke. “Two years have passed and China has no mRNA vaccines to offer.” —Bruce Einhorn 

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China rushes to develop an mRNA Covid-19 vaccine as doubts grow over local jabs

China's race to develop its own messenger RNA (mRNA) Covid-19 vaccine has gained greater urgency ...

People line up for nucleic acid testing for Covid-19 in Tianjin, China on Jan 9, 2022. PHOTO: REUTERS

Eleanor Olcott

PUBLISHED 

JAN 10, 2022, 11:48 AM SGT

LONDON (THE FINANCIAL TIMES) - China's race to develop its own messenger RNA (mRNA) Covid-19 vaccine has gained greater urgency as Beijing struggles to rein in an outbreak of the Omicron variant that is threatening its zero-Covid policy.

Beijing's pandemic strategy, in which the authorities implement strict lockdown measures on communities with local cases to quash any outbreak, has, according to China's official statistics, proved effective at preventing the large number of deaths suffered in some Western countries.

But it has left China isolated from the rest of the world and confined millions of its own citizens to their homes to prevent the virus from spreading.

Progress towards a domestic mRNA vaccine in China has been slow, as the country's pharmaceutical companies opted initially to use traditional inactivated virus technology in vaccines.

In November, Chinese biotech company Suzhou Abogen Biosciences and its partner Walvax Biotechnology received regulatory approval to test their mRNA vaccine candidate in a booster trial.

Their vaccine deploys the same type of technology used in the Moderna and BioNTech/Pfizer jabs, which provide higher levels of protection against the Omicron variant than existing Chinese-made shots.

Dr Jerome Kim, director-general of the International Vaccine Institute in South Korea, said Chinese pharmaceutical companies had opted for the "old-fashioned vaccine" because the "existing technology was easily available and had been used in vaccines that had inoculated billions of people".

But researchers maintain that this method produces a weaker immune response than mRNA and viral-vector vaccines, which induce a targeted response to the virus's spike protein as it enters human cells, compared with the inactivated vaccine, which attacks many viral proteins.

China has administered 2.8 billion doses of Sinopharm and Sinovac's inactivated virus vaccines to 1.2 billion people. But the lockdown of 13 million residents in Xi'an, where more than 1,758 cases have emerged over the past month in China's worst outbreak since the start of the pandemic in Wuhan, has underscored officials' lack of confidence in domestic jabs.

"The lower efficacy of the Chinese vaccines indicates that most people lack the necessary neutralising antibodies to prevent infection or severe cases," said Dr Jin Dong-yan, a virologist at the University of Hong Kong.

Research from the university showed that two jabs and a booster of Sinovac's vaccine provided insufficient protection against the Omicron variant, while another study demonstrated that both Chinese vaccines' efficacy declined quickly.

In November, Chinese academics published a study warning that moving away from Beijing's strict zero-Covid policy to one similar to the United States would overwhelm the medical system and spell disaster for the country.

The low efficacy of Chinese vaccines has had repercussions beyond its borders, as Beijing has exported 1.49 billion shots.

China has administered 2.8 billion doses of Sinopharm and Sinovac's inactivated virus vaccines to 1.2 billion people. PHOTO: AFP

One study of 185 healthcare workers in Thailand, which has not been peer-reviewed, found that 60 per cent of recipients of Sinovac jabs had high levels of neutralising antibodies one month after receiving their second jab, but that figure dropped to 12 per cent after three months.

Even as evidence of the weaker performance of its vaccines mounts, Chinese regulators have held off granting approval to the BioNTech mRNA vaccine. The German drugmaker has sought to enter the Chinese market through a distribution partnership with China's Fosun Pharma.

Dr Calvin Ho, a bioethicist at the University of Hong Kong, said Beijing had not recognised vaccines developed by foreign pharmaceutical companies because it wanted to support home-grown alternatives.

Investors are hoping the Walvax and Abogen vaccine, which is being developed alongside researchers from a Chinese military medical institute, will not face the same political barriers.

Last year Abogen, which was founded in 2019 and is based in Suzhou, west of Shanghai, raised US$1.1 billion (S$1.49 billion) from backers including Temasek, the Singapore state-backed investment fund, and investment firm Invesco.

Beijing has never authorised mRNA products for therapeutic use, putting domestic drug companies on the back foot as the strength of the technology became evident during the pandemic.

A leading Chinese respiratory disease expert, Dr Zhong Nanshan, said last month that China should "learn from other countries in areas they have done well, like mRNA vaccines. They have spent years developing it and managed to produce the mRNA vaccine in a few months".

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Hong Kong university's Dr Jin said that, because China was slow to develop mRNA technology, its pharmaceutical companies lacked the scientific know-how and specialised machinery to deliver the jab at scale.

He added that there were significant technical barriers to making lipid nanoparticles, the fatty shield that protects fragile mRNA molecules when entering human cells, which are difficult to create safely and in large quantities.

But Dr Kim said that it was only a "matter of time" before China has access to an mRNA vaccine and that the safe and effective lipid nanoparticles were available to be licensed if domestic companies could not produce their own.

Pre-clinical trial data showed the Walvax and Abogen vaccine candidate, which is called ARCoV, produced a robust antibody response against coronavirus during the animal testing phase. No data on the more conclusive later-stage trials on human subjects has been published.

But even if China rolls out an mRNA vaccine as a booster, experts warned that it may not be a silver bullet that gives the authorities the confidence to end its zero-Covid policy.

An immunology professor from Beijing, who did not want to be named, said that even if China rolled out its own mRNA vaccine, "it wouldn't have a big impact on China's pandemic control measures" since evidence from existing versions of the jab showed that breakthrough infections are still possible.

MORE ON THIS TOPIC

China's home-grown virus pill could offer a pivot from Covid-19-zero

MRNA vaccine access carves up world into haves and have-nots

Source: 

https://www.straitstimes.com/asia/east-asia/china-rushes-to-develop-an-mrna-covid-19-vaccine-as-doubts-grow-over-local-jabs

Others:

https://healthticket.blogspot.com/2022/05/chinas-bet-on-homegrown-mrna-vaccines.html

https://healthticket.blogspot.com/2022/04/chinas-biggest-covid-failure-is-not.html

https://arisechina.blogspot.com/2022/01/china-has-rejected-worlds-top-mrna.html

https://arisechina.blogspot.com/2022/01/china-rushes-to-develop-mrna-covid-19.html

https://healthticket.blogspot.com/2021/05/15-apr-21-how-china-passed-up-vaccine.html

https://healthticket.blogspot.com/2021/05/top-chinese-official-admits-vaccines.html

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