Showing posts with label Omicron. Show all posts
Showing posts with label Omicron. 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.”

___

Ghosal reported from New Delhi. Associated Press journalist Dake Kang in Beijing contributed to this report.
___

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

Monday, 12 December 2022

China finally approves an mRNA COVID vaccine—but only for some foreigners

 Two years after the first countries approved the Pfizer/BioNTech COVID vaccine for domestic use, China will finally allow the mRNA vaccine to be used domestically—but there's a catch.

On Friday, China confirmed in a press briefing that it would let German nationals receive the BioNTech COVID vaccine, which uses mRNA technology, in exchange for German health authorities on Wednesday approving China's Sinovac jab for Chinese nationals living in Germany.

The statement from China’s foreign ministry clarifies an earlier announcement by German Chancellor Olaf Scholz during his trip to Beijing that BioNTech would be made available to foreign nationals in China.

But Beijing's decision to approve the Pfizer/BioNTech jab for a sliver of China's population highlights the country’s uneasy relationship with mRNA vaccines and shots developed overseas as Beijing embarks on an exit from its tough COVID-zero policy, which will likely cause a massive outbreak.

Has China approved mRNA vaccines?

BioNTech is the first mRNA vaccine—and the first developed overseas—approved for use in mainland China, even if it's just available to German nationals living there.

Several Chinese companies are developing mRNA vaccines, but none have made it to final approval. In September, Indonesia—not China—became the first country to approve a Chinese-developed mRNA vaccine, from pharmaceutical company Walvax.

Fosun Pharmaceuticals, BioNTech's distribution partner for greater China, secured 100 million doses for the Chinese market in December 2020. Yet Fosun's applications to use its doses in mainland China are still pending, with no indication of when the mRNA vaccine will be approved for widespread use. (The semiautonomous Chinese city of Hong Kong approved BioNTech for use in its vaccination campaigns.)

China has largely relied on two vaccines, from Sinovac and Sinopharm, in its vaccination campaign. The two vaccines use an inactivated virus to confer immunity. Studies show that the two vaccines are less effective at preventing infection, severe disease, and death than the BioNTech and Moderna shots, which use mRNA technology.

Sinovac and Sinopharm are both developing boosters that specifically target the Omicron variant.

Public health officials have blamed China’s less-effective vaccines for hindering its ability to smoothly change its COVID policy. “The efficacy of the China‑made vaccines are not at the level of the vaccines that have been used in the United States,” Anthony Fauci, the outgoing White House medical adviser, told the Washington Post on Dec. 2.

How many Chinese have been vaccinated?

The more pressing problem, in Beijing's view, is not the effectiveness of its vaccines, but that not enough people are vaccinated. Official data released in early December shows that only 40% of China’s over-80 population has received a booster. Health officials at the time pledged to launch new campaigns to vaccinate China's elderly, but now the task is especially urgent.

Beijing announced sweeping changes to its COVID rules last Wednesday, including letting mild and asymptomatic cases recover at home and limiting lockdowns to individual floors and buildings, rather than whole neighborhoods. A pivot is likely good news for China’s economy, dragged down in November by a record COVID outbreak and widespread lockdowns. Chinese consumer sentiment last month fell to levels not seen since early 2020, the start of the pandemic, according to a survey released Sunday by Morning Consult.

But relaxed measures could lead to a surge in cases across China. One of the country’s top medical advisers predicted last week that as much as 60% of the country could catch COVID in an initial exit wave.

Chinese officials are now reassuring people that an increase in cases is not a cause for concern. State media quoted Zhong Nanshan, the country’s top medical expert, on Friday as saying that Omicron’s death rate is comparable to that of influenza.

This story was originally featured on Fortune.com

https://finance.yahoo.com/news/china-finally-approves-mrna-covid-065627541.html

Tuesday, 24 May 2022

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.”

Source:
Other reads:

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


Friday, 6 May 2022

Xi Jinping sends warning to anyone who questions China's zero-Covid policy

 By Nectar Gan, CNN

Updated 0614 GMT (1414 HKT) May 6, 2022


https://edition.cnn.com/2022/05/06/china/china-xi-pbsc-zero-covid-intl-hnk/index.html

Hong Kong (CNN)China's top leader Xi Jinping has issued the strongest warning yet against anyone who questions the country's zero-Covid policy, as stringent, frequent lockdowns fuel public discontent and deal a devastating blow to the Chinese economy.

At a meeting chaired by Xi on Thursday, the ruling Communist Party's supreme Politburo Standing Committee vowed to "unswervingly adhere to the general policy of 'dynamic zero-Covid,' and resolutely fight against any words and acts that distort, doubt or deny our country's epidemic prevention policies."
This is the first time Xi, who according to state media made an "important speech" at the meeting, has made public remarks about China's battle against Covid since public furor erupted over the harsh lockdown in Shanghai.
    "Our prevention and control strategy is determined by the party's nature and mission, our policies can stand the test of history, our measures are scientific and effective," the seven-member committee said, according to government news agency Xinhua.
      "We have won the battle to defend Wuhan, and we will certainly be able to win the battle to defend Shanghai," it said.
      The Standing Committee also demanded cadres have a "profound, complete and comprehensive understanding" of the policies set by the party's central leadership.
      "We should resolutely overcome the problems of inadequate awareness, inadequate preparation and insufficient work, and resolutely overcome contempt, indifference and self-righteousness in our thinking," it said.
      To analysts who have long observed Chinese politics, the stern warning is a sign that there has been internal pushback against Xi's zero-Covid policy from within the party.
      "This language should be read as a direct criticism of unspecified local CCP leaders who have questioned the policies at the center, or who have been insufficiently successful in applying them," wrote David Bandurski, co-director of the China Media Project.
      "And it is difficult not to hear in this phrase about 'self-righteousness' condemnation of leaders in Shanghai in particular," Bandurski added.
      Over the past five weeks, many Shanghai residents have taken to social media to call for help and vent their anger over severe food shortages and lack of access to medical care. Some protested from their windows, banging pots and pans and shouting in frustration, others even clashed with police and health workers in the streets -- a rare scene in a country where dissent is routinely suppressed.
      The grave economic fallout has also drawn concerns from economists and business executives, especially given Shanghai's role as the country's leading financial center and a major manufacturing and shipping hub. In April, China's services sector, which accounts for more than half of the nation's GDP and over 40% of its employment, contracted at the second sharpest pace on record, while the manufacturing sector also shrunk.
      And as Omicron spreads in other parts of China, more local governments are imposing swift lockdowns in response to just a handful of cases. In Beijing, where more than 500 cases have been reported since April 20, many fear for a Shanghai-style lockdown as authorities roll out increasingly restrictions.
      A boy receiving a Covid test in Beijing, China on May 4.
      But the latest statement from the country's top leaders has made it clear that the Chinese government is doubling down on its approach of relying on swift lockdowns, mass testing and quarantine to squash the highly transmissible Omicron variant for the foreseeable future.
      Wu Qiang, a political analyst in Beijing, said since April, the question over how the government should deal with the country's worst outbreak since Wuhan has evolved into a "path struggle" within the party.
      "Firstly, it is a struggle over whether it should choose 'dynamic zero-Covid' or a more flexible approach to fight Covid; and secondly, it is also a struggle over whether to make Covid control or economic growth the priority," Wu said.
      And with the latest statement, it is clear that Xi has picked the former in both "struggles," according to Wu.
        Xi has put his personal stamp on China's zero-Covid strategy, with state media often reporting that he has "personally commanded and made arrangements" for the country's fight against the pandemic.
        "In that sense, zero-Covid has become an unquestionable, unchallengeable policy that is closely tied to his political authority -- and therefore there will be no flexibility when it comes to its implementation," Wu said.

        Friday, 1 April 2022

        China Crushed Covid. But Covid Zero Could Crush China


        A new wave of infections is highlighting the growing cost of China’s zero-tolerance virus policy

        Updated on


        Workers from a public service organization deliver vegetables to residents of a Shanghai neighborhood in lockdown on March 29. Photographer: Hector Retamal/AFP/Getty Images


        China’s Covid Zero strategy has been drastic and effective, saving lives and keeping the economy on track. But a new wave of virus cases is highlighting the growing costs of that approach – as well as the perils of any attempt to change it. 

        Authorities are fighting to curb the spread of the omicron variant among a population that lacks natural immunity and only has access to home-grown vaccines that are less effective than some of the global alternatives. Shanghai – the country’s financial center – is locking down just weeks after the technology hub of Shenzhen was forced to do so.

        For the rest of the article refer to the link below ...

        Source:

        https://www.bloomberg.com/news/features/2022-03-31/china-s-covid-zero-strategy-what-could-xi-jinping-d

        Wednesday, 26 January 2022

        China has rejected the world’s top mRNA vaccines. Now, it’s making its own


        Until now, China has rejected the world's most effective and popular COVID-19 vaccine technology—mRNA jabs—and has instead relied on traditional, inactivated vaccines to achieve its 86.6% fully vaccinated rate. But inactivated vaccines are less effective against Omicron and, analysts suspect, China's exclusive use of the old tech is the primary reason why China's borders remain mostly sealed to the outside world.

        But this week a Chinese pharmaceutical company announced it is getting closer to developing a homegrown mRNA vaccine, which may prove a critical step in Beijing accepting the technology, providing a much-needed immunity boost to its 1.4 billion population, and finally reopening its borders.

        On Monday, Chinese vaccine maker Walvax Biotech published Phase I clinical data on China’s first homegrown mRNA vaccine showing that the vaccine induced an immune response. Walvax is jointly developing the vaccine with private vaccine maker Suzhou Abogen Biosciences and the Chinese military’s Academy of Military Science, and published the peer-reviewed study in The Lancet medical journal.

        In the study, Walvax gave six different groups of 20 people two jabs 28 days apart. One group received a placebo, while the other groups received differing doses—5, 10, 15, 20, or 25 micrograms—of the vaccine to gauge the intensity of immune responses.

        The results showed the mRNA jab has an efficacy between 80% and 95%, which is on par with the mRNA vaccine developed by Pfizer and BioNTech—but Bloomberg Intelligence analyst Mia He says those early figures don't tell the whole story.

        For one, He told Bloomberg, the Walvax vaccine appears to be more effective in generating antibodies than actually catching the virus when administered in certain concentrations. That finding suggests that unless dosing is extremely precise, getting the jab may not provide more protection than getting COVID-19. Other mRNA vaccines, like BioNTech's, don't have that problem.

        Plus, the Walvax vaccine appears to cause more side effects, such as fevers, than Pfizer’s or Moderna’s shots do. But the study remains the first clinical proof that China may have a viable homegrown mRNA jab to distribute to its population.

        Chinese authorities, meanwhile, appear to have iced out the country's other mRNA option: the BioNTech jab.

        Since March 2020, China’s Fosun Pharma has partnered with Germany’s BioNTech to market and distribute the proven and highly effective mRNA jab in the Chinese market. (Pfizer, which struck an agreement with BioNTech after Fosun did, controls distribution rights to BioNTech’s vaccine in most other countries.)

        Fosun Pharma has already distributed jabs to places where it controls distribution rights, including Hong Kong, Macau, and Taiwan, and has reportedly built manufacturing facilities to produce the mRNA vaccine in mainland China.

        But Beijing has yet to approve the vaccine for distribution in mainland China, despite BioNTech's mRNA shot being more effective than the inactivated vaccines from makers like Sinopharm and Sinovac that China is currently distributing to its citizens.

        Last July, when Walvax's drug was still in development, the company's director of research development, Dr. Tong Xin, told Fortune he was optimistic that an mRNA jab would eventually launch in China because "the vaccine technology has been proved effective." But Walvax still has a long way to go before it can bring its drug to market.

        Walvax reports it is currently conducting Phase III clinical trial for its vaccine in Mexico and Indonesia, but it is still recruiting the volunteers it needs to carry out the tests. Finding volunteers is increasingly difficult as global vaccination rates have increased since the pandemic began. The trial requires unvaccinated test subjects.

        The stakes may be high for Walvax to complete its trials soon and begin rolling out the jabs.

        On Wednesday, Bloomberg reported that Hong Kong’s European Chamber of Commerce expects mainland China—and Hong Kong by proxy—to remain closed off from the world until the country starts administering an mRNA vaccine as a booster to its 1.4 billion citizens. The chamber believes that China may only feel confident in opening its borders once citizens can get boosted with more effective mRNA vaccines.

        But the chamber said it expects that process of boosting citizens with mRNA shots to take up to two years, with China and Hong Kong potentially remaining closed until the spring of 2024.

        Source:

        https://fortune.com/2022/01/26/china-covid-vaccine-mrna-homegrown-walvax-reopen-borders/


        Other reads:

        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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