Third-stage testing of Chinese Covid-19 vaccines continues
Nov-03-2020 By : fcccadmin
China National Pharmaceutical Group Co (Sinopharm), is stepping up efforts to develop Covid-19 vaccine candidates, the China Daily reports. Third-stage clinical trials of its two inactivated vaccine candidates, developed by the company’s vaccine and bioscience subsidiary China National Biotech Group (CNBG), are being conducted in 10 countries, including the United Arab Emirates (UAE), Jordan, Argentina, Egypt and Peru, said Liu Jinzhen, the company’s Chairman. Currently, there are around 60,000 volunteers, as people from more than 125 nations joined the vaccine trials, he said.
According to an October 19 document from the World Health Organization (WHO), there are 44 Covid-19 candidate vaccines in clinical evaluation, among which 10 have reached the final stage of testing. China currently has 13 vaccine candidates in clinical trials, and among them three inactivated vaccines and one adenovirus vector vaccine are in phase three trials overseas, according to the Ministry of Science and Technology. Dozens of countries have already contacted CNBG to express interest in buying the vaccines once they have received official approval, according to Liu. Both vaccines have already been approved for emergency use in China in high-risk groups, such as frontline medical personnel, border staff, and people traveling overseas to work.
CNBG has completed building high biosafety production bases with a capacity that will exceed one billion doses next year to meet widespread demand for vaccination. Shanghai Geneodx Biotech Co, an affiliate of CNBG, is also one of the first three companies in China to develop coronavirus test kits, and CNBG is the first in China to develop convalescent plasma treatment for Covid-19 patients. Sinopharm ranked 169th on the Fortune Global 500 last year, and fourth among pharmaceutical companies, the China Daily reports.
After four days of nucleic acid testing of 4.7 million people in Kashgar prefecture in Xinjiang 61 new infections were discovered, bringing the total to 273 – 54 confirmed and 219 asymptomatic cases. Still, the risk that the virus would spread was small, epidemiologists said. Kashgar city remains open and outbound tourists are allowed to leave with a negative nucleic acid report and only the four most affected villages were labeled as high-risk areas. Epidemiologists are still looking for the source of the infection. Most infections are concentrated in Shufu county, but some were also detected in neighboring Akto county.
Despite sporadic outbreaks, a second wave of Covid-19 infections is not likely to happen in China thanks to forceful prevention and control, according to China’s leading respiratory disease expert Zhong Nanshan. Although the pandemic may worsen in most countries in the northern hemisphere, there is little possibility for the coronavirus to hit hard again in China, he added.
China has issued a draft regulation on compulsory insurance for Chinese vaccine manufacturers, saying it will better protect the legal rights of vaccine recipients and strengthen oversight of the industry. The draft regulation, released by the National Medical Products Administration for a month of public consultation, includes mandatory liability insurance for all licensed vaccine suppliers on the Chinese mainland to ensure they can provide compensation for recipients injured or killed by substandard vaccines. It mandates the establishment of a nationwide minimum liability limit, with at least CNY500,000 in compensation for a death and indemnities for injuries. “The overall safety and quality of domestic vaccines is well guaranteed. But vaccine products, from China or overseas, always carry inevitable risks, so devising an adequate compensation mechanism in advance is necessary,” said Du Yifang, Law Professor at Fudan University in Shanghai. China’s Drug Administration Law, which also applies to vaccines, already stipulates that people harmed by substandard drugs are entitled to compensation.
China CDC warns coronavirus can spread from frozen food products; vaccine to be available soon
Oct-27-2020 By : fcccadmin
The coronavirus can pass from objects to humans, and exist in cold chain conditions for a long time, the Qingdao government in Shandong province announced, as it revealed how the virus spread from imported frozen food products in the latest outbreak in the city. The discovery was made public by Luan Xin, Deputy Mayor of Qingdao. China Customs told the Global Times they have been upgrading spot checks of imported goods, with emphasis on imported cold chain products, starting in September, even before Qingdao’s announcement that it discovered “object-to-human” virus passage. The Chinese Center for Disease Control and Prevention (CDC) announced that it had detected and isolated living coronavirus in a positive sample from the outer packaging of imported frozen cod.
It was the first time the presence of the virus has been confirmed in the cold chain transport outside the laboratory and the virus can survive in cold chain conditions across borders. Wholesalers who purchase imported cold chain products have to report to local authorities 24 hours before the food arrives, said Chen Wansheng, a Qingdao official. Fan Xubing, a senior seafood industry analyst, told the Global Times that he does not think it is necessary to check every imported product, since the costs would be too high. “Under normal circumstances, the proportion of Customs spot checks will be 1%. But since sampling is random, no one can cheat on it,” said Fan. “The scale of frozen fish and meat imports is too large to completely cut off, and Customs authorities are strengthening spot checks on cold chain items to almost all containers,” a Customs officer told the Global Times. According to the Shanghai Daily, Qingdao Customs will conduct nucleic acid testing on all imported cold chain products. A Beijing Customs source said that the situation has put pressure on their work, and that Beijing has already suspended some cold chain related imports.
Meanwhile, 164 asymptomatic cases were reported in Kashgar prefecture in Xinjiang. They are all connected to a clothing factory where the parents of the first asymptomatic patient work. The 17-year old woman did not leave Shufu county in the past year and did not have contact with a known virus carrier. Chinese epidemiologists are now looking for the source of the infection, but warn that there could be a community outbreak and cases might be confirmed in the coming days. A Level-1 emergency response has been activated and all close contacts of the infected persons have been isolated for medical observation and testing. All 4.7 million people in the prefecture will be tested in three days time. The outbreak marks the Chinese mainland’s first local infection since October 14, when one was detected in Qingdao. Xinjiang was the site of a local cluster in August, but no new cases had been found in the region since August 15.
Concerning vaccine development, Chinese authorities refuted Western media reports that China has rolled out experimental Covid-19 vaccines to the general public. They are still only used for emergency purposes to vaccinate Chinese personnel traveling to high-risk areas abroad. This emergency use has been undertaken in line with relevant laws and regulations in China with the support of the World Health Organization (WHO), Zheng Zhongwei, an official from the National Health Commission (NHC) in charge of technology development, told a press conference. All those who have received the vaccination under the emergency plan have shown no severe adverse reactions, Zheng added. Zhejiang was the first province in China to announce that it will make Covid-19 vaccinations available to the public, but vaccinations have not started yet. “The vaccination is reservation-based, and it only covers key groups of people. Ordinary people have no access to the vaccines yet,” an official from the Yiwu Center for Disease Control and Prevention (CDC) in Zhejiang province told the Global Times. Key groups of people covered by vaccines for emergency use include medics, workers involved in anti-epidemic prevention and control work, border control staff, and those who ensure city operations and management, according to the Yiwu city government. China has 13 vaccine candidates in clinical trials, including four in phase-3 trials. Around 60,000 volunteers have been inoculated with one of the four advanced vaccine candidates. Initial indications are that the vaccines are safe. China is expected to produce up to 610 million doses of Covid-19 vaccines by the end of this year, Zheng Zhongwei, head of China’s coronavirus vaccine development task force said, the Shanghai Daily reports. “Manufacturing conditions are mature, and the vaccines are ready. We’ll probably see them available to the public as soon as next month, or if not, by the end of this year,” a Beijing-based immunological expert who requested anonymity told the Global Times.
China joins global COVAX vaccine facility
Oct-13-2020 By : fcccadmin
China has joined the Covid-19 Vaccines Global Access Facility, honoring its commitment to turn Covid-19 vaccines into a global public good. China signed an agreement with the Global Alliance for Vaccines and Immunization on its participation in the COVAX facility on October 8. “Even when China is leading the world with several vaccines in advanced stages of R&D and with ample production capacity, it still decided to join COVAX,” Foreign Ministry Spokeswoman Hua Chunying said. “We are taking this concrete step to ensure equitable distribution of vaccines, especially to developing countries, and hope other capable countries will also join and support COVAX,” she said. China will strengthen vaccine cooperation with other countries through the COVAX network, she added. With the Covid-19 pandemic still posing a severe threat to all countries, Hua stated that China will continue to work together with COVAX partners and contribute its share to the global fight against the pandemic to safeguard the safety and health of everyone.
COVAX is led by the World Health Organization (WHO) and two other groups: GAVI, which was founded 20 years ago as the Global Alliance for Vaccines and Immunization to make vaccines more available, and CEPI, the Coalition for Epidemic Preparedness Innovations, which helps finance and coordinate new vaccine development. COVAX aims to speed up the development and manufacture of Covid-19 vaccines and to guarantee fair and equitable access. It aims to have 2 billion doses available by the end of 2021. All participating countries and regions, regardless of income levels, will have equal access to a portfolio of vaccines once available. The facility is designed so that richer countries agree to buy potential vaccines and help finance access for poorer ones. China’s participation in COVAX represents a new move to strengthen international cooperation to fight the pandemic, said Su Xiaohui, Deputy Director of the Department for International and Strategic Studies at the China Institute of International Studies. COVAX helps ensure the ability to pay does not become a barrier to accessing Covid-19 vaccines, Su said, and China’s involvement will help developing economies benefit from the global vaccine initiative and have equal access to safe and effective vaccines. More than 160 countries and regions have joined the initiative, while the U.S. announced in September it would not participate in global coronavirus vaccine efforts.
China has four of the world’s nine vaccines in the third phase of clinical trials, typically the last step before regulatory approval. Two are developed by the China National Pharmaceutical Group, and the remaining two are from United States-listed Sinovac Biotech and Hong Kong-listed CanSino Biologics, the China Daily reports.
The Global Times adds that COVAX is one of the three pillars of the Access to Covid-19 Tools (ACT) Accelerator, which was launched in April by several global organizations including the WHO, Gavi and the Coalition for Epidemic Preparedness Innovations in response to the Covid-19 pandemic. As of September 21, 156 countries and regions had agreed to join the Covid-19 vaccine allocation plan, but the U.S. is not among them. China was also not among the first 156 countries to have announced their participation because the country was still in communication about some details, according to analysts. “The COVAX facility is especially important to developing countries as it ensures equal access to Covid-19 vaccines for both developed and developing countries,” Qiu Dongxu, Senior Vice President and Co-Founder of CanSino Biologics, said. The company targets a yearly output of 200 million to 300 million doses. A recombinant Covid-19 vaccine candidate co-developed by CanSino and a team led by Chinese military expert Chen Wei is currently undergoing Phase-III clinical trials in Pakistan and Russia, and primary results of the trials are expected in early 2021.
After 57 days of reporting no locally-transmitted Covid-19 cases, China reported a small outbreak in the city of Qingdao in Shandong province, identifying 6 locally-transmitted and 6 asymptomatic cases, all linked to the Qingdao Chest Hospital. Close contacts of the cases all tested negative and the city government decided to test all 9 million residents of the city within five days. Although 4.5 million tourists visited Qingdao during the National Day holiday from October 1 to 8, authorities estimate that the risk of people in other cities becoming infected remained small.
Vaccine work continuing, virus no longer circulating in Chinese society
Sep-15-2020 By : fcccadmin
As work on developing a vaccine is continuing in China, Chief Virologist Wu Zunyou said people in China planning to travel during the upcoming National Day holiday do not need to take additional precautions against the coronavirus as the disease is no longer circulating in society. Currently, on the Chinese mainland, the virus can only be found in hospitalized patients, people placed under medical observation and laboratories, Wu, Chief Epidemiologist at the Chinese Center for Disease Control and Prevention, said during an interview with China Central Television. “It is now impossible to contract the virus in social environments, including schools and workplaces,” he said.
This year’s National Day Holiday will run from October 1 to 8, one day longer than usual as it overlaps with the Mid-Autumn Festival, which also falls on October 1 this year. Tourist agencies have predicted a surge in domestic travel during the eight-day holiday as the outbreak has been suppressed in the country and most travel restrictions have been lifted. No new locally transmitted infections have been reported on the Chinese mainland for more than 30 consecutive days.
CanSino Biologics’ top scientist Zhu Tao said that its vaccine candidate for Covid-19 jointly developed by the company and military biomedical expert Chen Wei is generally safe and effective, and no serious adverse reactions that require medical attention have been reported. The Chinese recombinant adenovirus vector vaccine, Ad5-nCoV, uses a weakened and modified common cold virus as a vector to introduce parts of the genetic material of the novel coronavirus into the body, training it to recognize and fight off the disease. Zhu said the Ad5-nCoV is expected to provide two years of protection, and one dose is enough to trigger an adequate immune response.
China’s only nasal spray vaccine against the novel coronavirus is expected to start phase I clinical trials in November, and 100 volunteer recipients are being recruited, meaning that all five technical routes of vaccines against the disease that China has introduced will be in clinical trials. It is the only vaccine of its type approved by China’s National Medical Products Administration. China has approved 10 coronavirus vaccines for clinical trials. This nasal spray vaccine is a collaborative mission between Hong Kong and the Chinese mainland that involves researchers from the University of Hong Kong, Xiamen University and Beijing Wantai Biological Pharmacy. Leading microbiologist from the University of Hong Kong Yuen Kwok-yung told the Global Times that the vaccine simulates the natural infection pathway of respiratory viruses to activate the immune response. The nasal spray vaccination could generate double protection for vaccine recipients – influenza and the coronavirus. The nasal spray vaccine uses live attenuated influenza vaccine; the other four technical routes China is using to develop coronavirus vaccines are inactivated vaccines, adenoviral vector-based vaccines, and DNA and mRNA vaccines. The inactivated vaccine is estimated to be the earliest to be on the market.
Quarantine policies for international travelers to Shanghai with their final destination in neighboring Jiangsu, Zhejiang or Anhui provinces have changed. While the total length of quarantine for inbound passengers remains 14 days, people traveling to the three neighboring provinces and testing negative after three days of quarantine in Shanghai – instead of the previous seven days – will be transferred to their city of destination to finish the last 11 days of quarantine in designated places. Inbound travelers whose destination is within Shanghai are still allowed to do a seven-day hotel quarantine plus a seven-day home quarantine if they have a fixed residence in the city, a negative nucleic acid test on the fifth day of the hotel quarantine and mandatory home quarantine for those living in the same apartment.
Travelers from Belgium to China need to note that starting from September 2, the validity period of the negative Covid-19 test certificate was shortened from 5 to 3 days after its issuance for all passengers traveling from or transiting via Belgium to China. This means that travelers need to pass a test and obtain a negative certificate within three days before departure. Foreigners need to present the test result to the Chinese Embassy in Brussels to obtain a Health Certificate to be allowed to board the plane to China.
China reports no domestic Covid-19 cases for more than 14 days
Sep-01-2020 By : fcccadmin
China has reported no new Covid-19 cases for more than 14 days, but there are still a dozen or so cases a day of arriving passengers, detected carrying the virus during their 14-day quarantine period. Meanwhile, the number of Covid-19 cases in Belgium has surpassed the number in China, while there are twice as many deaths in Belgium.
Urumqi, capital city of Xinjiang, lifted the lockdown after 37 days to allow residents of some local communities where there have been no Covid-19 patients to engage in outdoor activities within the community as infections have gradually subsided. In response to difficulties that locals had during the long lockdown, major officials in Urumqi released their phone numbers, allowing them to hear residents’ anxiety and help solve their problems. The easing is a sign that the Covid-19 resurgence is gradually subsiding and Urumqi is expected to return to normality soon after the city locked all communities and required residents to stay indoors from July 17. As another easing sign, some domestic airlines serving Xinjiang started to resume operations, including some flights to Beijing, Shanghai and Hangzhou. Travelers need a green health QR code and negative nucleic acid test to board the flights, the Global Times reports.
Hong Kong plans to start mass testing on September 1. The number of daily cases has been dropping in the past week, from a peak of 149 in late July to around 10 to 20 in recent days. But restrictions and social distancing measures still have a serious impact on the economy of Hong Kong. A total of 141 sites across 18 districts have been prepared as makeshift testing facilities. “For yourself, your loved ones, our hardworking medical staff and the wider community, you should join the testing,” Secretary for the Civil Service Patrick Nip said. Those who test negative for Covid-19 would receive their results via text message within three days of screening, while those testing positive would get a call from the Department of Health. The Hong Kong government had conducted 950,000 tests since January, and had recently performed 420,000 tests on high-risk groups – such as taxi drivers and care home staff. The mass testing scheme is aimed at detecting the remaining silent carriers of the virus. About 600 staff from the mainland will assist in testing. But Professor Yuen Kwok-yung, who advises the government on the pandemic, says infections could spike again as temperatures fall. He called for ‘watertight’ border controls, and for people to record their own movements to facilitate contact tracing in the event of infection. Hong Kong could face a fourth wave of Covid-19 infections in the autumn and winter season, and disruptions to normal life could persist for another six months to a year, he added.
Shanghai’s Fosun Pharma is on track to bring German partner BioNTech’s mRNA Covid-19 vaccine to China by the end of the year. Fosun has injected 72 volunteers with BioNTech’s vaccine in a phase-one trial in Jiangsu province, and the preliminary safety data are ‘good’, said CEO Wu Yifang. “We hope to be able to commercialize it by year end, but there are plenty of uncertainties with clinical trials as well as the regulatory approval processes,” Wu added. Fosun Pharma, part of the Shanghai-based conglomerate Fosun International, in March obtained a license from Mainz-based BioNTech to exclusively develop and commercialize its mRNA Covid-19 vaccine in mainland China, Hong Kong, Macao and Taiwan. U.S.-based Pfizer is working with BioNTech to commercialize it outside China, and is conducting phase 2 and 3 clinical trials in the U.S. where it has won “fast track” designation from the Food and Drug Administration (FDA). They plan to supply up to 100 million doses worldwide by the end of this year and 1.3 billion by the end of 2021. RNA vaccines are faster and cheaper to produce than traditional vaccines, and an RNA-based vaccine is also safer for the patient as they are not produced using infectious elements.
Meanwhile, the Canadian National Research Council (NRC) confirmed a planned clinical trial of the Ad5-nCov vaccine developed by CanSino had been scrapped due to delays in shipping the vaccine. The NRC said it was now working with Massachusetts-based VBI Vaccines and the University of Saskatchewan’s International Vaccine Center. Phase three trials of Ad5-nCoV are now under way in Saudi Arabia and Russia. The Chinese military has already approved the use of the vaccine candidate on armed forces personnel.
- KURT VANDEPUTTE (UMICORE) APPOINTED CHAIRMAN OF THE BOARD OF THE FLANDERS-CHINA CHAMBER OF COMMERCE (FCCC)
- Webinar: “Knowing Your Chinese Partner” – May 26, 2021, 10 am – 12 am
- EMA starts rolling review of CoronaVac, WHO approves Sinopharm vaccine for emergency use
- The Global Times warns not to politicize the Comprehensive Agreement on Investment (CAI)
- Hainan to become biggest duty-free market in the world