Experts Warn of China’s Emergency Use of COVID-19 Vaccine

China in recent months has been injecting hundreds of thousands of people with three preliminary coronavirus vaccianes that are being tested for safety and efficacy.While the world awaits a proven drug to fight the pandemic, at least three vaccine candidates have been given to front-line medical professionals, staff of state-owned companies, and government officials since July under an emergency use program approved by Beijing.China National Biotec Group (CNBG), a subsidiary of state-owned Sinopharm, has administered two experimental vaccine candidates to around 350,000 people outside its clinical trials, CNBG chairman Yang Xiaoming said recently. The company also donated 200,000 doses of one of the candidate vaccines that is still undergoing clinical trials in Wuhan, where the pandemic was first reported.Another drugmaker, Sinovac Biotech, has injected 90% of its employees and their family members, or about 3,000 people, Yin Weidong, the company’s CEO, said this month.”At present, tens of thousands of people in Beijing should have been vaccinated with Sinovac’s vaccine,” Yin told Chinese state media.Separately, Beijing also gave approval in June for members of the armed forces to receive an experimental vaccine developed by CanSino Biologics, a biopharmaceutical company that is backed by the military.A man works in the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, in Beijing, China, Sept. 24, 2020.Phase 3 trial importantForeign experts have criticized using the experimental vaccines before clinical trials have been completed.”It is reckless and dangerous to distribute a minimally tested vaccine about which nothing has been published,” said Dr. Arthur Caplan, head of the division of medical ethics at New York University’s Grossman School of Medicine.”Puts too many people at risk without opportunity to study safety and efficacy in a large group,” Caplan told VOA in an email.Vaccines usually require years of research and testing before being made available to the public. In Phase 3 trials, vaccines are generally given to thousands of people and tested for safety and efficacy.”Before the completion of Phase 3 trials, we cannot have full confidence in the safety and effectiveness of a vaccine,” Lawrence Gostin, professor of Global Health Law at Georgetown University, told VOA.Under China’s law, vaccines developed for major public health emergencies can be deployed for urgent use if the National Medical Products Administration considers that the benefits of the treatment outweigh the risks.Experts say speeding up the process introduces more risk, which could undermine the vaccination effort in the long run.“This practice can backfire if the rushed process causes a widespread distrust of the vaccine when fewer people are willing to take the vaccine. Or it can cause severe damages when vaccine complications were warned, due to the rushed trials, “Dr. Jennifer Huang Bouey, an epidemiologist and China expert at the RAND Corporation, told VOA.Most candidates failCurrently, there are 42 vaccine candidates that are being tested on humans, 11 of them developed by Chinese companies.Nurse Isabelli Guasso administers China’s Sinovac potential vaccine for the COVID-19 to volunteer Dr. Luciano Marini, at the Sao Lucas Hospital of the Pontifical Catholic University of Rio Grande do Sul in Porto Alegre, Brazil Aug. 8, 2020.According to the American Council on Science and Health, a research and education organization, vaccines for infectious diseases in clinical trials only have a 33.4% success rate, meaning that most of the vaccines that entered the stage of clinical trials will fail.China claims that so far, there have been no obvious adverse reactions among the people who were inoculated.”Tens of thousands of people vaccinated have traveled to countries and regions with high risks of COVID-19. No one has been infected so far, and this proved the effectiveness of the vaccines,” said Zhou Song, chief legal adviser of CNBG.A box for a COVID-19 vaccine is displayed at an exhibit by Chinese pharmaceutical firm Sinopharm at the China International Fair for Trade in Services (CIFTIS) in Beijing, China, Sept. 5, 2020.There are 11 candidates in Phase 3 trials, four of them are developed by Chinese companies. While Phase 3 is the final stage, it does not necessarily mean that successful results are imminent.A U.S. Food and Drug Administration study in 2017 found that vaccine candidates that had encouraging Phase 2 results could still fail. Of the 22 vaccines in Phase 3 trials that scientists studied, 14 of them did not confirm the effectiveness of the product that was indicated in Phase 2 trials. One vaccine in the study had a safety problem identified in Phase 3.”If the vaccine is ultimately proven to be poorly protective against the virus — which it may — they will have exposed many people to unnecessary risks and perhaps given people false confidence that they are protected, which undermines public health,” Dr. Charles Holmes, director of the Georgetown University Center for Innovation in Global Health, told VOA.Beijing’s global reachIt is possible that within weeks the world will see its first proven coronavirus vaccine, as some of the Phase 3 trials are expected to complete as early as November.China now has more candidates in the final stage of trial than any other nation and has been using the prospect of a vaccine’s discovery to shore up its global standing.Chinese vaccine developers are currently working with more than 40 countries and carrying out clinical trials in at least 10.The United Arab Emirates has recently approved a Chinese vaccine candidate for emergency use, making China the first nation to receive approval to deploy a COVID-19 candidate in a foreign country.Through various platforms like the Belt and Road Initiative, and the Association of Southeast Asian Nations, Beijing has promised to prioritize doses for dozens of countries. Officials are also claiming the countries’ vaccine makers are ramping up production.“Next year, our annual capacity will reach more than 1 billion doses,” said Zheng Zhongwei, director of the National Health Commission’s Science and Technology Development Center, at a news conference last Friday.A visitor wearing a face mask looks at a model of a coronavirus and boxes for COVID-19 vaccines at a display by Chinese pharmaceutical firm Sinopharm at the China International Fair for Trade in Services (CIFTIS) in Beijing, Sept. 5, 2020.Despite Beijing’s asserted ability to develop and deliver vaccines, experts warned that China is not necessarily ahead in the global vaccine race.”Before a Phase 3 trial is completed and a manufacturing capacity is used, any country that has a promising vaccine candidate can be equally successful,” said Bouey.Gostin, who is also the director of the World Health Organization Collaborating Center on National and Global Health Law, said China and its partner countries are exposing people to significant risk by deploying the vaccine before it has completed a large-scale placebo-controlled trial.”China is trying to exploit other countries, gaining political or commercial advantage in return for the vaccine,” Gostin said.In Indonesia, China’s Sinovac Biotech promised it would help Indonesia’s state-owned drugmaker Bio Farma produce at least 40 million doses of its potential vaccine before March 2021.Muhammad Zulfikar Rakhmat, an academic at Universitas Islam Indonesia who researches China’s foreign policy in Indonesia, told VOA in an email that right now, there is little public attention on the risks of taking the experimental vaccine.”Most concerns are about whether the vaccine would work or not and if Indonesians have only become subjects of trial,” Rakhmat said.  

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Hot Baths Can Ward Off Cardiovascular Diseases, Study Shows

New research suggests that taking hot baths, soaking in hot tubs or using saunas can prevent cardiovascular diseases such as heart disease, high blood pressure and Type 2 diabetes. The research was presented last week at the Annual Meeting of the European Association for the Study of Diabetes (EASD), held virtually this year. Hisayuki Katsuyama, co-author of the new study, is a physician at Kohnodai Hospital in Ichikawa, Japan. He says that while drug treatments have helped people with Type 2 diabetes live better, longer lives, daily habits such as diet and exercise are still important for these patients.  Katsuyama says he and his colleagues looked at previous research suggesting heat therapy, such as baths, hot tubs or saunas, can lower risks of fatal heart disease and stroke, along with having a lower body fat percentage, and thought it could be promising as a Type 2 diabetes treatment. To test the theory, the researchers recruited 1,297 patients with Type 2 diabetes who regularly visited an outpatient hospital unit in Ichikawa between October 2018 and March 2019. They documented their bathing habits and noted water temperature, frequency and duration of each session, as well as a variety of medical notes.  Across the board, people who bathed more often had lower body mass indexes (BMI), diastolic blood pressure and glycated hemoglobin, a key risk factor for Type 2 diabetes. In their presentation, the researchers say their findings suggest daily heat exposure by hot tub bathing can “contribute to improvements of glycemia, hypertension and obesity, and thus, can be a therapeutic option for patients with Type 2 diabetes.” In an interview, Katsuyama says he suspects patients may benefit from heat therapy in a way similar to the benefit they get from exercise. He says both seem to improve insulin sensitivity and enhance energy expenditure.  Other research suggests bathing increases blood circulation, body temperature and the production of nitric oxide in the body, which appears to confer the positive benefits. Katsuyama says more research is needed before more conclusions can be made. The study has not yet been published or peer reviewed.
 

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Australia’s COVID-19 Hotspot, Victoria State Reports 5 New Cases

Officials in Australia’s Victoria state – considered the nation’s COVID-19 hotspot – reported five new cases Monday, the lowest case number in more than three months. At a news conference, Victoria State Premier Daniel Andrews told reporters the state would immediately lift an overnight curfew that has been in place for the past month. He said beginning in October, most children will return to school, and many businesses, including manufacturing, construction and food processors can reopen, sending more that 125,00 people back to work.Andrews acknowledged the sacrifices people had made and said clearly their strategy had worked. As recently as early August new daily COVID-19 cases peaked at 725. But Andrews stressed the need to remain vigilant. “If we start doing things that we know deep down are not the right thing to do, then we can put at risk everything that we’ve built, everything that Victorians have given. I don’t want that to happen and I’m confident it won’t,” he said.Melbourne, Australia’s second largest city, and surrounding parts of rural Victoria state were placed under strict “Level 4” lockdowns on Aug. 2, closing schools and non-essential businesses, imposing a nighttime curfew and prohibiting public gatherings.Many restrictions remain in place. Public gatherings of no more than five people from a maximum of two households will be allowed, and masks are still mandatory in public. But Andrews said a further easing could take place on October 19 if the average falls below five new cases per day.Overall, Australia has been one of the more successful nations in controlling the outbreak, with 27,000 total cases in a population of 25 million. Andrews said there are 359 active cases in Victoria.

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Rabbis Ponder COVID-19 Queries of Ultra-Orthodox Jewish Life

Must an observant Jew who has lost his sense of taste and smell because of COVID-19 recite blessings for food and drink? Can one bend the metal nosepiece of a surgical face mask on the Sabbath? May one participate in communal prayers held in a courtyard from a nearby balcony?
 
Months into the coronavirus pandemic, ultra-Orthodox rabbis in Israel are addressing questions like these as their legions of followers seek advice on how to maintain proper Jewish observance under the restrictions of the outbreak.
 
Social distancing and nationwide lockdowns have become a reality around the globe in 2020, but for religious Jews they can further complicate rites and customs that form the fabric of daily life in Orthodox communities. Many of these customs are performed in groups and public gatherings, making it especially challenging for the religious public to maintain its lifestyle.  
 
One religious publisher in Jerusalem released a book in July with over 600 pages of guidance from 46 prominent rabbis. Topics range from socially distanced circumcisions (allowed) to Passover Seders over Zoom (forbidden) to praying with a quorum from a balcony (it’s complicated).
 
One rabbi responded to a query about blessings on food for those who lost their sense of taste and smell due to the coronavirus. His ruling? Prayers are still required, for “even though one does not sense the flavor of the food, his intestines nonetheless benefit and are satisfied by the food and its nutrition.” He then launched into a two-page legal argument citing rabbinic sources from the Talmud on down.
 
The collection — titled “Havieni Hadarav,” Hebrew for “Bring me to his chambers” — is one of many pamphlets, books, radio and social media Q&As published in recent months addressing matters of halacha, or Jewish religious law, during the pandemic.
 
Ultra-Orthodox Jews make up a little over 10% of Israel’s 9 million citizens and adhere to a close observance of Jewish law. The foundations of halacha are built on the Torah’s commandments and prohibitions, and the Talmud, a codification of Jewish law written down over the course of the early centuries of the first millennium.
 
Orthodox Jewish practice is the byproduct of generations of rabbis issuing legal arguments and rulings. Their decisions, known as responsa, can sometimes be lenient and other times strict.  
 
“Every time a rabbi is asked a question, he has to essentially do what a judge would do, and bring up previous cases which he builds upon to come to his decision in this particular case,” said Issamar Ginzberg, a Jerusalem-based Hassidic rabbi. The method of questions and responses has underpinned centuries of the Jewish legal code.
 
There’s no way to say for sure how many people will follow this particular book’s rulings. But there are hundreds of thousands of ultra-Orthodox Jews, and opinions by prominent rabbis often carry great significance in daily life within the community.  
 
“It’s more like a law textbook than a novel on the bestseller list,” said Ginzberg.
Rabbi Natan Feldman, head of the Tzuf Publishing House and editor of “Havieni Hadarav,” said the company has sold around 3,000 copies of the book, which meets “the need of the hour.”
 
“If people didn’t have it, they would err in all kinds of ways,” Feldman said. “It’s something with a lot of utility.”  
 
Israel’s ultra-Orthodox minority has been disproportionately affected by the coronavirus pandemic, with cities and neighborhoods where they live among the country’s current hot zones. Overall, Israel has recorded around 200,000 cases of the novel coronavirus and more than 1,300 deaths. The Health Ministry does not break down those numbers by population groups.  
 
Religious areas have been hard hit in part because they tend to be poorer and crowded, but also because of the tight-knit communal lifestyles, in which synagogues and seminaries play a central role. Some ultra-Orthodox schools have remained open in defiance of a nationwide lockdown imposed earlier this month to help clamp down on the country’s surge in new cases. While some rabbis have resisted orders to limit crowd sizes at prayers, especially for the current High Holiday season and this week’s gatherings for Yom Kippur, or the Day of Atonement, the government has tried to work with religious leaders to spread the word on promoting public health regulations and restricting the sizes of prayer gatherings.
 
Many of the responsa contend with the complications of holding prayers — which traditionally require a quorum of 10 adult men — outdoors and in a manner that complies with social distance regulations. The rabbis offered differing opinions on what the law allows regarding participating in a minyan held in a communal courtyard from a balcony above.  
 
Innovation has helped overcome some of the challenges of the lockdown but has also raised additional concerns for observant Jews. For example, can one enter a hospital on the Jewish Sabbath if there is a thermal camera at the entrance that takes visitors’ temperatures?  
 
Activating such an electronic device could violate multiple prohibitions, so Rabbi Asher Weiss — a prominent ultra-Orthodox legal scholar involved in “Havieni Hadarav” — advised refraining from entering if only visiting a patient, but those in need of medical care ought not “avoid entering the hospital and endanger their lives.”
 
But the bottom line, written by Weiss in the book’s introduction, is that people must “take extra care to adhere to the instructions of qualified medical officials and the regulations of the Health Ministry and not violate them.”  
 
Weiss did not respond to interview requests.
 
For Feldman, the publishing head, the tome of coronavirus laws not only helps those who desire to adhere to halacha, it’s a reminder for the future of the tribulations Jews faced during this outbreak.
 
“If there should be, God forbid, another pandemic in the century to come, there will at least be a memory, some kind of necessity for the coming generations,” he said. 

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Країни G20 проведуть віртуальний саміт

Зустріч лідерів «Групи 20» цього року матиме місце у віртуальному форматі. Вона призначена на 20-21 листопада поточного року. Про це йдеться у спільній заяві G20

Головуватиме на саміті король Саудівської Аравії Сальман бен Абдель Азіз Аль Сауд.

«Майбутній саміт G20 буде зосереджений на захисті життя людей і відновленні економічного зростання. Для цього будуть розглянуті вразливі місця, які розкрилися під час пандемії, і закладені основи для світлого майбутнього», – мовиться у заяві.

Станом на 28 вересня у світі підтвердили понад 33 мільйона випадків COVID-19, померли майже 998 тисяч пацієнтів, одужали – майже 23 мільйона.

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Sri Lanka Returns Hazardous Waste to Britain

Sri Lanka says it is shipping 21 containers of waste back to Britain.  Officials said hazardous waste materials, including hospital waste, were found in some of the containers, in violation of international laws and European Union regulations.  Officials said the containers were supposed to be holding used mattresses, rugs and carpets for possible recycling. An AFP reports says the containers arrived in Sri Lanka between September 2017 and March 2018. The containers left Sri Lanka bound for Britain Saturday, officials said.  Several Asian countries have said they are tired of being the garbage dump for wealthy nations and have refused docking privileges to ships transporting waste. 

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