Chinese vaccine scheduled to go to market in December
Aug-25-2020 By : fcccadmin
An inactivated Covid-19 vaccine developed by the China National Pharmaceutical Group (Sinopharm) will likely come on the market by the end of December, at a price of less than CNY1,000 for two shots. The marketing review procedure will start after overseas phase III clinical trials are completed, Chairman Liu Jingzhen said. Not all 1.4 billion Chinese people need to be vaccinated, Liu added, suggesting that students and those working in cities should take the injections, while people who live in rural areas with comparatively smaller populations do not have to. Sinopharm started to offer free voluntary injections to front-line medical workers in some state-owned hospitals on an urgent basis in late July. Some employees of SOEs preparing to go abroad were also offered Sinopharm’s inactivated vaccine for urgent use as early as June. Getting vaccinated would be free for Chinese citizens if the vaccine is included in the national immunization program, which covers 14 injections against 15 diseases like polio and hepatitis B. A workshop in Beijing able to produce 120 million doses per year has passed biological safety inspection from the related authorities and is ready for production. Another workshop of Sinopharm in Wuhan is able to produce 100 million doses per year.
The China National Biotec Group (CNBG) announced it will start its Phase Ⅲ clinical trials of Covid-19 vaccines in Peru and Morocco, after obtaining certificates to launch trials in the United Arab Emirates (UAE) and Bahrain. Another vaccine maker, CanSino Biologics, has reportedly reached a deal with the Mexican government.
Meanwhile, the American Chamber of Commerce received permission to fly business executives to China on a chartered flight on September 12, but tight restrictions remain on those allowed to re-enter China. Almost 200 people signed up for a San Francisco to Beijing charter flight. The Chamber said that only those who were employed by member companies who had received a letter of invitation, known as a PU letter, would be allowed on the flight. They also must obtain a valid re-entry visa. Family members will be permitted to travel with the employee, but all passengers will be required to pass a Covid-19 test before boarding and must enter quarantine upon arrival. The price of the flight operated by United Airlines is expected to be “competitive with current commercial rates”, with economy class seats starting at USD4,300 and business class seats starting at USD10,000. AmCham China estimates that between 5,000 and 10,000 members of the U.S. business community are currently stuck overseas, while the European Chamber’s Shanghai chapter said 56% of companies have staff stuck overseas. The German Chamber of Commerce has previously been able to arrange a charter flight for members, which landed in Tianjin in late May. Around 950,000 foreigners in China have permission to work in China, the South China Morning Post reports.
The U.S. Department of Transportation has decided to double the number of flights to China to eight per week, equivalent to the total number of flights now permitted by Chinese aviation authorities to U.S. carriers. That means the number of international flights between China and the U.S. are expected to increase from the current eight flights to 16 flights per week. The two U.S. carriers currently operating passenger flights to China – United Airlines and Delta Air Lines – were granted operating permission by the Civil Aviation Administration of China (CAAC) to increase their service frequency from two times a week to four. VariFlight said that in September 72 routes have been planned to depart from 14 cities in the U.S., compared with 70 routes in 17 cities in China, which means the carriers in the two countries have submitted a total of 142 flight plans, much more than the number of flights approved by the two countries’ regulators. There were around 100 flights a week between the two countries before the pandemic.
As of August 12, China maintained regular passenger traffic with 50 countries, and altogether 93 airlines, including 19 domestic and 74 foreign companies, have been operating 210 weekly return frequencies on 187 international passenger routes, the CAAC said.
China grants first invention patent to Covid-19 vaccine
Aug-18-2020 By : fcccadmin
Chinese authorities have granted the first invention patent to a domestically developed Covid-19 vaccine candidate. The vaccine is a recombinant adenovirus vaccine named Ad5-nCoV, co-developed by Chinese biopharmaceutical firm CanSino Biologics and a team led by Chinese military infectious disease expert Chen Wei. The grant of the patent confirmed the vaccine’s efficacy and safety, and convincingly demonstrated the ownership of its intellectual property rights (IPR), CanSino said in a statement to the Global Times. CanSino applied for a patent with the National Intellectual Property Administration (NIPA) on March 18, three days after launching phase one clinical trials, and received approval on August 11. The phase III trial is now progressing smoothly abroad. China and Russia planned to collaborate on Covid-19 vaccine clinical trials.
Covid-19 vaccines must have an efficacy rate of at least 50% and provide at least six months’ immunity if they are to be approved for use in China by the Chinese Center for Drug Evaluation (CCDE), which added in a document that it would consider granting emergency use of vaccines that have not yet completed the final phase of clinical trials. Chinese companies are among the forerunners in the race to produce a vaccine for Covid-19, with four candidates in final testing. Last week, China issued several documents setting out the standards for clinical trials and research on vaccines, including those based on the unproven mRNA platform. Four Chinese vaccine candidates are undergoing clinical trials in the United Arab Emirates (UAE), Brazil, Saudi Arabia and Indonesia. Those countries were chosen as China no longer has enough cases to put the products to the test. The trials are, however, smaller than the usual size of 20,000 to 40,000 patients, so more locations might be sought at a later date.
One of the most promising Covid-19 vaccines will be available in China as a result of a licensing deal between AstraZeneca and Shenzhen Kangtai Biological Products. This agreement means that five out of the six vaccines that are currently undergoing phase 3 human trials will be available in the country. The vaccine, jointly developed with Oxford University’s Jenner Institute, has shown promising results in early trials, with volunteers producing a strong immune response without serious adverse effects. Under the deal, Kangtai will have exclusive clinical development, production and commercialization rights to the vaccine in China. “BioKangtai will ensure the annual production capacity of the Covid-19 vaccine AZD1222 can reach at least 100 million doses by the end of 2020, and expand capacity to at least 200 million doses by the end of 2021 to meet the demands of the Chinese market,” AstraZeneca said in a statement. Other Chinese companies have already agreed to deals with foreign companies to secure access to Covid-19 vaccines. In March, Shanghai Fosun Pharma bought the exclusive collaboration and commercial rights in China for a vaccine from German bio start-up BioNTech. BioNTech is currently conducting phase 2 and 3 trials for the vaccine with Pfizer outside China and a phase 1 trial for safety and immune responses inside China. In January, U.S. firm Inovio Pharmaceuticals announced that it was partnering with Beijing-based Advaccine for clinical trials of a vaccine and would seek regulatory approval to enter the Chinese market, the South China Morning Post reports.
Shares of Tianjin-based CanSino Biologics, China’s first drug maker to start human trials of a Covid-19 vaccine, shot up by 124% on their debut in the Star Market. The company will use the proceeds to build a vaccine manufacturing base and fund Covid-19 vaccine research. Shares always soar on the first day of trading on the Star Market, which, unlike other Chinese trading boards, has no limit on how much they can rise or fall in the first week of trading, making them especially profitable bets. The average first-day gain on the Star Market is 167%, according to data provider jrj.com. CanSino, which raised CNY5.2 billion by floating 24.8 million shares on the Star Market at the Shanghai Stock Exchange, is the second most expensive initial public offering (IPO) on the mainland, trailing only Beijing Roborock Technology, a robot cleaner maker that began trading on the Star Market in February. According to China’s Ministry of Industry and Information Technology (MIIT), a total of 13 enterprises in China have launched construction of assembly lines to produce Covid-19 vaccines as of July 23, while nine Chinese enterprises have received regulatory approval to start clinical vaccine trials.
Urumqi, capital city of the Xinjiang Uygur Autonomous Region, re-mains on high alert against Covid-19 and is giving repeated nucleic acid tests to people at high risk of infection, although the number of cases in the city is showing a downward trend and has fallen to single digits per day. Single-day new infections in Xinjiang peaked near the end of July, reaching as high as 112 on July 30 and have since been declining. In Hong Kong, a cluster linked to the Kwai Tsing Container Terminals, kept growing. So far, 65 confirmed cases were linked to Hong Kong’s biggest container terminal. Hong Kong is recruiting some 2,000 people with medical knowledge to help with mass testing, which will start on August 31 and last for two weeks. Social-distancing measures have also been extended by one week. The city has registered 4,525 infections and 69 deaths so far.
With at least nine Chinese cities reporting cases of imported frozen products contaminated with the coronavirus since early July, authorities are taking measures to prevent further such incidents. Officials in Shenzhen, Guangdong province, confirmed that a sample of frozen chicken wings imported from Brazil tested positive, while some packaging samples from frozen shrimp tested positive in Xian, Shaanxi province. China’s customs authority suspended imports from three Ecuadorean shrimp producers on July 10 after samples collected from the outer packaging of shrimps and the interior of a container in which they were shipped tested positive for the virus in Xiamen, Fujian province, and Dalian, Liaoning province. Michael Ryan, Executive Director of the Health Emergencies Program at the World Health Organization (WHO), said in Geneva that: “People should not fear food or food packaging, or the processing or delivery of food. There is no evidence that food or the food chain is participating in transmission of this virus. Our food, from a Covid perspective, is safe.” Zhu Yi, Associate Professor at China Agricultural University’s College of Food Science and Nutrition Engineering, said that the contamination actually has nothing to do with the food or packaging. The key is the cold-chain temperature in which viruses can survive, Zhu said, as reported by the China Daily.
First Covid-19 vaccine plant receives production certificate
Aug-11-2020 By : fcccadmin
China made another breakthrough in battling the coronavirus pandemic as an inactivated Covid-19 vaccine production plant of the Beijing Institute of Biological Products has passed national examination. The facility was granted a production certificate and it is now available for use, its parent China National Biotech Group (CNBG) said. The Beijing institute took only two months to finish building the facility on April 15. Related government departments conducted a thorough biosecurity examination of the production workshop in July, and concluded the facility met national standards, and could go into operation for mass production of Covid-19 vaccines. After the Beijing manufacturing workshop and another production facility belonging to CNBG’s Wuhan Institute of Biological Products begin operations, CNBG will be capable of ensuring an annual capacity of 220 million doses of vaccines to first immunize medical staff and personnel working at airports and border checkpoints. “It is possible that China could have a Covid-19 vaccine as early as the end of October as some domestically made Covid-19 vaccines have entered phase three clinical trials and need about a month to observe their effects on samples,” Tao Lina, a Shanghai-based vaccine researcher, told the Global Times. After securing a certain amount of vaccine for China’s strategic reserves, exports can be considered, Tao noted, adding countries such as the Philippines and Brazil are potential destinations.
Sinopharm’s candidate vaccine is already being tested in the United Arab Emirates (UAE) with 15,000 local volunteers, including UAE nationals and expatriates, since mid July. Sinopharm is the parent company of CNBG. In another major step, German firm BioNTech and its Chinese partner Shanghai Fosun Pharmaceutical announced that 72 trial participants have received doses of BNT162b1, a Covid-19 vaccine candidate based on BioNTech’s mRNA technology, following the Chinese regulators’ examination and approval. In another sign of progress, scientists from the Hong Kong and Macao Special Administrative Regions announced a breakthrough in the development of a recombinant Covid-19 vaccine, envisioning the vaccine’s mass production to be feasible at a low cost in the future. A Spokesperson for the Ministry of Industry and Information Technology (MIIT) said in late July that China has 13 firms that have begun capacity building for Covid-19 vaccines, and nine have been approved to start clinical trials, the Global Times reports.
China’s Covid-19 testing capacity can fully meet domestic demand with a very high accuracy rate, authorities said. According to MIIT, China’s daily Covid-19 nucleic acid testing capacity hit 4.84 million at the end of July, with 4,946 institutions and more than 38,000 technical staff now capable of carrying out tests. Nearly 200 million testing kits and 12,000 testing machines have been distributed nationwide. The number far exceeds daily tests run by the U.S. According to the Coronavirus Resource Center of John Hopkins University, the highest daily test capacity in the past three months in the U.S. was only 920,000. By comparison, China’s testing capacity has successfully met the demand of 10 million people in Wuhan, and more than 20 million in Beijing. The current capacity is enough to test “everyone that wants to get tested” and “everyone who needs to be tested,” according to Bao Xianhua, an official from China’s Ministry of Science and Technology. Apart from traditional testing kits, China has focused on the development of rapid testing kits. According to China’s National Products Administration, it has thus far approved 44 Covid-19 testing kits from 36 enterprises, including seven rapid ones. The current fastest Covid-19 testing kit in China provides results in 30 minutes, and the overall accuracy rate of nucleic acid testing in the country has reached 95%. Rapid testing kits are among China’s top development priorities, with further kits expected to receive approval by the fall. As of July 7, around 20 publicly-listed companies are not only producing testing kits in China, but also exporting them overseas, the Global Times reports.
According to epidemiologists, the Covid-19 cases in Dalian were imported. The possibility of clustered infections in Dalian being caused by domestic cases can be preliminarily ruled out, as the cases have been found to be unrelated to those discovered in Beijing and Xinjiang, local authorities said. Zhao Zuowei, Director of the Dalian Health Commission, said at a press conference that gene sequencing showed that the virus which caused the infections is different from that circulating domestically. Experts are working on tracing the source of the particular strain. The infections likely started in the Dalian Kaiyang Seafood Company’s processing workshops on July 9 and rapidly spread among the workshops before spreading outside. The outbreak occurred in a comparatively limited area without leading to wider community transmission, Zhao noted. The expansion of Covid-19 cases in Urumqi has also been contained.
In Hong Kong, 69 new cases were confirmed on August 10, bringing the total to 4,148 with 55 related deaths. The Hong Kong government also revealed it would extend existing social-distancing measures, including a ban on gatherings of more than two people, and mandatory mask-wearing in public places, until August 18.
This overview is based on reports by the Global Times, South China Morning Post, China Daily and Shanghai Daily.
China reports less than 50 new Covid-19 cases daily
Aug-04-2020 By : fcccadmin
Barricade at the entrance to a residential compound in Dalian in February
The last couple of days, China daily reported less than 50 confirmed cases and less than 25 asymptomatic cases. However, before dropping again, the number of daily infections discovered had risen to the highest in three months, propelling fears of a new wave of the pandemic.
New clusters have now been detected in several cities. A cluster in Dalian in Liaoning province spread infections to eight other cities within five days, and the city government decided to test the whole population within four days. The comprehensive testing prioritized residential communities that are densely populated, with all costs covered by the government, the Dalian Health Commission said. The Commission assigned more than 3,300 medical employees to assist in administering nucleic acid tests. Like in Wuhan and Beijing, Dalian also adopted the sample pooling test method, mixing five samples together as a group. If found positive, each sample will be tested separately to determine which one is infected.
As the number of cases in Hong Kong continue to increase, the SAR government first banned in-house dining in the evening, then expanded it to include breakfast and lunch, to retract the expansion after only 48 hours because many employees had no other option but eating in the street even in high temperatures and heavy rain. A truck driver traveling between Hong Kong and the Chinese mainland was confirmed with a Covid-19 infection, prompting Shenzhen to test thousands of residents and step up measures to prevent the port from becoming a loophole in the mainland’s epidemic control work. Given frequent interaction between Hong Kong and Shenzhen, and the worsening infection situation in Hong Kong, analysts said Shenzhen ports as well as nearby cities should raise entry requirements and conduct more tests to identify silent carriers and reduce transmission risks. Wang Peiyu, Deputy Dean of Peking University’s School of Public Health, said it is unrealistic to completely shut down the border ports between Hong Kong and Shenzhen given the frequent interactions. A more realistic method to prevent the virus from spreading is that the Shenzhen side should manage to identify silent virus carriers and give repeated tests if necessary to reduce the risks of allowing people with false-negative nucleic acid tests in, Wang told the Global Times. Medical personnel from mainland China is going to Hong Kong to help conduct mass Covid-19 testing, after the city confirmed another 121 coronavirus cases, the tenth straight day of triple-digit increases in infections. Mainland staff will also help with the construction of community isolation and treatment centers. Hong Kong has reported 3,396 Covid-19 cases since the beginning of the epidemic and 33 related deaths.
Northwest China’s Xinjiang Region is also still fighting against Covid-19 clusters. Experts said after gene sequencing the virus in Xinjiang that it is similar to the viral strain of Beijing’s recent outbreak, and that with support from across China, the region is expected to bring the situation under control within one to two weeks. There is a large number of asymptomatic cases. Many patients were tested before they showed symptoms, which is a good sign for epidemic control, Zhang Yuexin, Director of the Infectious Disease Department of the First Affiliated Hospital of Xinjiang Medical University, told the Global Times. Yang Zhanqiu, Deputy Director of the Pathogen Biology Department at Wuhan University, told the Global Times that the summer season and high temperatures might weaken the effect of the virus on individuals so they display fewer symptoms.
The China Daily reported that Sansure Biotech, a company based in Changsha, Hunan province, has independently developed a fast Covid-19 nucleic acid testing system, which shortens detection time to within one hour. The system doesn’t require a professional laboratory and gives a test result within 15 to 45 minutes. The system obtained the National Medical Products Administration approval and the European Union’s CE mark in April.
China continues to battle Covid-19 outbreaks in Urumqi, Dalian and Hong Kong
Jul-28-2020 By : fcccadmin
As the coronavirus outbreak in Beijing has now ended, China is battling new clusters of infections that emerged in Urumqi, capital of Xinjiang, the port city of Dalian in Liaoning province, and in Hong Kong.
In Dalian, employees working at the Dalian Kaiyang Seafood Co were found to be infected, with the source of the infection unknown. Local seafood markets remain closed and some subway services were suspended. 12 new confirmed cases were reported on July 26. The outbreak ended Dalian’s record of zero Covid-19 cases for 111 days. All the new cases were working in the same area at a local seafood processing company, according to an official report. To curb the spread of infections, the city plans to test its six million residents within four days. The seafood company has suspended its operations and all employees are under medical observation. Dalian authorities said they had acquired detailed information related to the imported products and trading channels of the company, and they will begin to track the source of the infection as soon as possible. The Covid-19 cases could deal a blow to the seafood industry in Dalian, a coastal city that relies heavily on the seafood business, even though authorities did not reveal whether the first patient contracted the virus through seafood or cold-chain products. The Chinese government also issued a guideline, demanding that all imported meat products must be provided with a nucleic acid test certificate before coming into industrial plants for processing, the Global Times reports. Meanwhile, the infection originating in Dalian has spread to six other cities in three provinces.
In Urumqi, nucleic acid testing for more than 1.6 million people was completed, including all the residents in Tianshan district where most confirmed cases were reported as well as in Shaybak district. Urumqi reported more than 100 cases, and about the same number of asymptomatic cases since the outbreak started on July 15.
“First Wuhan’s Huanan seafood market; then the Xinfadi wholesale market in Beijing and now the patient working at a seafood company, it reminds us of the risks associated with cold chain products and how easily they can spread Covid-19,” Wang Guangfa, Respiratory Expert at Peking University First Hospital in Beijing said.
Hong Kong is going through its third wave of the pandemic. The city was setting records last week and 128 new cases were reported on July 26 – the fifth consecutive day of a three-digit spike in cases – taking the total number of infections to 2,633, with 18 related deaths. The AsiaWorld-Expo center is being converted into a ‘mobile cabin hospital’. The Center for Health Protection’s Dr Chuang Shuk-kwan said the next one to two weeks will be key in determining if social-distancing measures are working. Hong Kong Chief Executive Carrie Lam said she would institute a lockdown only if ‘absolutely essential’. Dr Chuang added: “We are very worried about whether this situation can be controlled actually.”
Experts said sporadic cases might be common in the future, underscoring the significance of implementing regular disease control measures and taking precautions. According to newly-released documents, public facilities that see dense and highly mobile crowds – such as office buildings, hotels, malls, banks, restaurants and food markets, as well as institutions that are deemed at higher risk of spreading the virus, including primary and high schools, elderly care homes, prisons and mental health clinics – should all step up their preparedness for the virulent disease. Preparations will include stocking virus control equipment, formulating emergency plans, enforcing strict temperature-taking and implementing social-distancing protocols. In low-risk areas, these public facilities can operate normally. However, in medium- or high-risk areas, business hours will be shortened and the number of people gathering reduced. Cinemas, theaters and karaoke bars in medium-or high-risk areas should be closed. In-person visits to elderly care homes, child welfare homes and prisons will be prohibited and replaced with virtual visits, the China Daily reports.
From July 27 onwards, people who arrive in Shanghai from overseas can spend half of their quarantine period at home if certain conditions are met, local authorities announced. On condition that they have residency in the city, live apart from family members who don’t have to be quarantined or live with people who agree to be quarantined along with them, they will be sent home to resume their quarantine on the eighth day if their nucleic tests on the fifth day are negative and if they apply to be quarantined at home. Qualified persons will be transported directly from collective quarantine facilities to their homes by the authorities of the districts in which their homes are located. Meanwhile, the government said it will continue to allow conditional home quarantine for senior citizens, underage people, pregnant and breast-feeding women, people with mobility restrictions, those who have to take care of other family members, and people with certain diseases. For those whose destinations are Jiangsu, Zhejiang and Anhui provinces, after seven days of collective quarantine in Shanghai, they will be transported to their destinations to continue their quarantine under the condition that their nucleic tests on the fifth day are negative. Those whose destinations are other parts of China will still be placed under 14-day concentrated quarantine, the Shanghai Daily reports.
KLM Royal Dutch airlines resumed passenger flights from Amsterdam Schiphol to Shanghai following the relaxation of travel restrictions by the Chinese government. KLM now operates one flight per week to Shanghai, and makes a stop in Seoul on both outbound and inbound flights. Apart from KLM, other foreign carriers such as Air New Zealand, Delta, United Airlines, Air France, Lufthansa, Swissair, Aeroflot and Turkish Airlines have also resumed flights to Shanghai. Finnair also resumed flights between Helsinki and Shanghai. Passengers on China-bound flights must provide negative Covid-19 test results (for Chinese passengers) or health certificates issued by the Chinese Embassy (for foreigners) before boarding.
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