Research, editing : Gan Yung Chyan, KUCINTA SETIA
News on disease control, Taiwan, CCP
News (1)
Paraguay’s "Immune Bridging" Phase III first dose has been delivered. Medigen: There is data in Q4
Reporter : Ye Weichen / Image : Video Screenshot
Since Medigen has not yet obtained the interim data of the third phase clinical trial, it has started vaccination. So the protection power is questioned. Medigen is still conducting Phase III clinical trials in Paraguay by way of immune bridging. Medigen issued a statement on 4 November 2021 that it has completed the first dose of vaccine for 1030 subjects in Paraguay's Phase III clinical trial on 3 November 2021. In the fourth quarter of this year, safety and immunogenicity comparative data will be obtained.
Gao said that the Paraguayan regulatory agency DINAVISA, based on the data from Taiwan's expansion of the Phase II trial for more than 3,000 people, believes that the vaccine safety data has met the regulatory requirements, so the total number of cases in Paraguay's Phase III immune bridging trial is only required to be 1,000 people. This trial is a 1:1 comparison between the Medigen vaccine group and the AZ vaccine group. The two doses are administered 28 days apart, and blood samples are collected 14 days after the second dose for immunogenicity comparison. It is expected to be obtained in the fourth quarter of 2021 the safety and immunogenicity comparison data to accelerate the deployment of the vaccine in Central and South American markets.
Medigen pointed out that the current international regulatory alliance ICMRA and the Access Consortium, composed of five countries including Australia and Canada, are actively advocating the immune bridging test of the covi vaccine.
In addition to the implementation of the Medigen vaccine in Paraguay and the AZ vaccine's head-to-head phase III clinical trial, it has also become one of the WHO solidarity trial vaccines. It can join the global 40,000-scale vaccine through the funding of WHO and trial countries to innovate the third phase of the "shared placebo group" trial.
Medigen emphasizes that having both the traditional Phase III and Immune Bridge Phase III clinical data will not only support the overseas market layout in the future, but also have the opportunity to become a representative of immunogenicity comparison and vaccine protection evaluation. Standards, and even research results are published in international journals, are provided to vaccine developers at home and abroad as scientific reference.
Refs: news.tvbs.com.tw/life/1626054, https://ec.ltn.com.tw/article/breakingnews/3726153
News (2) to (11) / Reporter : Xu Meng'er / Editor : Lin Congwen / https://www.epochtimes.com/gb/21/11/4/n13352496.htm
News (2)
The mainland epidemic spreads to 19 provinces, now community and family transmission
Image : On 26 September, residents of Harbin, Heilongjiang Province, were undergoing nucleic acid testing. (STR/AFP via Getty Images)
Since mid-October, the number of confirmed cases of covid has been on the rise in CCP China. This round of the epidemic has spread to 19 provinces and cities. There is community transmission and family transmission.
According to incomplete statistics from CCP media, this round of the epidemic has affected Beijing, Hebei, Gansu, Inner Mongolia, Guizhou, Heilongjiang, Shaanxi, Qinghai, Chongqing, Sichuan, Hubei, Jiangxi, Yunnan, Ningxia, Shandong, Hunan, Henan, Jiangsu, Zhejiang, etc. 19 provinces.
As of 9 pm on 3 November, there are 3 high-risk areas and 55 medium-risk areas on the mainland.
News (3)
Covid cases in Zhengzhou never disappear
Starting from 4 November, the fourth phase of Yinji Dynasty Phase IV of Weilai Road Office, Jinshui District, Zhengzhou, Henan, was adjusted to a medium-risk area.
News (4)
Covid case in Chengdu
On 3 November, the Shouchuang Jiaozi No. 1 community in Jinjiang District, Chengdu, was adjusted to a medium-risk area.
News (5)
Covid restricted areas in Chongqing
On 3 November, the three places in Chongqing were classified as medium-risk areas: Chongqing Xingchong New Energy Technology Co., Ltd. office area, No. 398, Jinshi Avenue, Shipanhe Community, Baoshenghu Street, Yubei District, and 53 Huanglong Road, Longta Street, Yubei District No. Dongyuan Qingtianjian Community, a group of Central Park Community, No. 88 Xierzhi Road, Guzhen Community, Puti Street, Changshou District.
Zhejiang Tongxiang Wuzhen Scenic Area issued an announcement on the evening of the 3rd, and Wuzhen Dongzha Scenic Area, Xizha Scenic Area and Wu Village will stop tourists from entering from the 3rd. Some venues, shops, restaurants, etc. in the scenic spot temporarily cease operations.
News (6)
Yunnan suspends domestic travels
In addition, starting from 3 November, Yunnan Province has suspended travel agencies and online travel companies from operating cross-provincial team tours and "air ticket + hotel" business.
The National Health Commission of the Communist Party of China reported on 4 November that from on 3 November, there were 87 local cases in 31 provinces (45 in Heilongjiang, including 44 in Heihe and 1 in Harbin; 23 in Hebei, including Shijiazhuang) 20 cases in Beijing City, 3 cases in Xinji City). On the 2nd, there were 93 newly confirmed local cases in 31 provinces of the mainland, and 11 new local asymptomatic infections.
News (7)
Heilongjiang records the most number of cases
As of 12 am on 3 November, Heilongjiang had 189 local confirmed cases and 2 local asymptomatic infections. There are 58 confirmed cases in Hebei Province.
In the morning of 4 November, Shijiazhuang, Hebei Province held a press conference on epidemic prevention and control. Zhang Fengzhen, deputy mayor of Shijiazhuang Government, said that the current epidemic situation in Shijiazhuang is still relatively severe.
News (8)
Covid outbreak after attending wedding banquets
In this round of the epidemic, there was also a virus infection due to playing cards or attending wedding banquets. Recently, people diagnosed in the city of Xinji and their children went to Shenze County to attend wedding banquets, and among the family diagnosed in Shenze County, some patients also went to Xinji to participate in adult college entrance examinations and wedding banquets. Among the confirmed cases in Beijing, 5 people were infected while playing cards together.
Family gatherings and community transmission have also occurred in many parts of the mainland.
On 30 October, the State Council’s Joint Prevention and Control Mechanism held a press conference and stated that community transmission has occurred in Heilongjiang Province and there is a risk of spreading and spilling.
News (9)
Covid cases in Shangrao on 31 October
On 1 November, a press conference in Jiangxi reported that on 31 October, there were 1 confirmed patient and 4 cases of asymptomatic infection in Jianshan County, Shangrao City, and most of them were in direct family or roommate relationships.
News (10)
Covid cases in Beijing on 2 November are family transmission
On 2 November , Beijing officials reported that on the 2nd, 4 new local confirmed cases were confirmed in Beijing. It is reported that the 4 confirmed cases all come from the same family and live in the second district of Tiantongyuan North, Tiantongyuan North Street, Changping District.
As of 2 pm on 3 November, Beijing has reported a total of 38 confirmed cases and 1 asymptomatic infection. There are also some reported infected persons outside the province who have taken transit trains or stayed in Beijing.
News (11)
Covid outbreak in Shijiazhuang claims at least 20 cases
In the early morning of 4 November 2021, Shenze County, Shijiazhuang City, announced that between 0:00 and 24:00 on 3 November, 20 new cases were confirmed in Shenze County, and 5 cases were to be re-examined. Of the 20 confirmed cases, 15 were from Hezhuang Village, Daqiaotou Town, 4 from Xihe Village, Daqiaotou Town, and 1 from Jiayue Shangcheng Community, Shenze County. The youngest was only 2 years old.
According to Xinji’s report on the evening of 3 November, the 3 confirmed cases in Xinji were all primary school students and came from Xiaozhang Primary School, Xiaoxinzhuang Township, Xinji.
News (12)
CCP China reports newly added 87 local confirmed covid cases and 16 asymptomatic covi infections
According to the National Health Commission, 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 87 newly confirmed local cases (45 in Heilongjiang, including 44 in Heihe and 1 in Harbin) from 4 November, there were 23 cases in Hebei, including 20 cases in Shijiazhuang and 3 cases in Xinji; 4 cases in Ningxia, all in Yinchuan; 3 cases in Changzhou, Jiangsu; 3 cases in Henan, including 2 cases in Zhengzhou and 1 case in Zhoukou; 2 cases in Inner Mongolia, both in Alxa League; 2 cases in Sichuan, both in Chengdu; 2 cases in Gansu, including 1 case in Lanzhou and 1 case in Tianshui; 1 case in Rizhao, Shandong; 1 case in Shapingba District, Chongqing; 1 case in Xining, Qinghai, including 2 cases that were converted from asymptomatic infections to confirmed cases (1 case in Shandong and 1 case in Sichuan). There were no new deaths. There were 3 new suspected cases, all imported from abroad (all in Shanghai).
31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 16 new cases of local asymptomatic infections (6 cases in Henan, all in Zhengzhou; 5 cases in Jiangxi, all in Shangrao City; 1 case in Heilongjiang, in Harbin; 1 case in Jiangsu, in Changzhou; 1 case in Jiaxing, Zhejiang; 1 case in Rizhao, Shandong; 1 case in Dehong Dai and Jingpo Autonomous Prefecture, Yunnan; 3 cases were converted to confirmed cases on the same day (1 case imported from abroad) 6 cases were released from medical observation on the same day (all imported from abroad); 406 cases of asymptomatic infection were still under medical observation (343 cases imported from abroad).
The current round of the epidemic continues to ferment. Since Xi’an reported 2 positive cases on 17 October 2021, over 700 new local positive cases have been reported nationwide in more than ten days. Among them, the trajectory or gene sequencing of 497 positive infections has been compared with Inner Mongolia, Gansu and other places. The epidemic is directly or indirectly related.
Image : Beijing Daily
News (13)
Novavax kicks! Approved by Indonesia EUA, Novavax will ship 20 million doses
Image : Novavax two-dose covi vaccine has applied for emergency use authorization (EUA) from many countries, and finally announced on the 1st that it has obtained the first EUA in Indonesia. (Associated Press, Euronews Press, synthesized by LTN)
Novavax, a US biotech company, said on the 1st that its two-dose covi vaccine has obtained the first Emergency Use Authorization (EUA) in Indonesia.
According to comprehensive foreign media reports, the covi vaccines of Novavax, Taiwan's Medigen MVC-COV1901 and UBI Asia's UB-612 all use protein subunit technology. The third phase of large-scale clinical trials conducted in the United States and Mexico showed that the vaccine’s protective power exceeds 90%, including effective against various mutant virus strains, and the vaccine has mild side effects.
After Indonesia obtained the EUA, Novavax said that it expects to start shipments to Indonesia soon. The vaccine purchased in Indonesia will be produced by the Serum Institute, the world's largest vaccine manufacturer, and sold under the Covovax brand of the Indian company.
The Indonesian government claims that the country will receive 20 million doses of Novavax vaccine this year.
This vaccine is different from some other vaccines that must be stored in extremely low temperature devices and can play an important role in increasing the supply of vaccines in poorer countries in the world. According to Indonesian epidemiologists, “this vaccine is easier to transport, store and distribute in places with many islands like Indonesia”.
Novavax and the Serum Institute of India have pledged to provide more than 1.1 billion doses of vaccine to the COVAX platform led by the World Health Organization (WHO).
In addition, the company has applied for emergency use authorization in the United Kingdom, the European Union, Canada, Australia, India and the Philippines, but has not yet been approved; in addition, the company is expected to apply to the US government by the end of the year.
News (14)
China Airlines and EVA Air resume flights to London in December 2021
One of the world's top three travel exhibitions, the "World Travel Mart" (WTM) physical exhibition, closes on 3 November. This year, the Taiwan Pavilion has received more active contacts from tourism industry and media than before. In addition, China Airlines and the British branch of EVA Air also announced the resumption of London-Taipei direct flights in December.
Taiwan’s Central Epidemic Command Centre announced on the 3rd that it would remove the United Kingdom from the list of “key high-risk countries”, and people who have entered from the United Kingdom do not need to be quarantined in a centralized quarantine station for 14 days.
Coincidentally, China Airlines and EVA Air also announced the resumption of London-Taipei direct flights that had been grounded for nearly five months in December. The Taiwan Pavilion held the highlight of the lottery, and the grand prize was the premium economy class ticket of EVA Air's direct flight.
The London Office of the Tourism Bureau was established in December 2019. Although business development was quickly affected by the epidemic that raged around the world last year, it continued to accumulate Taiwan’s visibility through online activities and placement marketing; epidemic prevention achievements, changes in the international atmosphere, etc. Factors have also helped to increase interest in Taiwan from all walks of life in the UK for more than a year.
Li Sixian, the director of the office, told the Central News Agency that since last year, the eagerness to get to know the British industry and the media in Taiwan has almost made the office "overwhelmed." Taiwan’s biggest selling point is that travelers can experience the ever-changing natural scenery and multicultural sceneries in a relatively short period of time. What is surprising is that the number of people who want to learn more about Taiwan by staying for a few weeks is increasing.
Based on her extensive negotiation experience in the Taiwan Pavilion at the London Travel Expo in the past three days, Li Sixian said that many potential partners expressed the hope that they would have an "original" travel experience with local characteristics and without excessive packaging. Help the local economy and environment.
In addition, themed and customized tours are also very popular. Those with higher inquiries include Taiwan’s cycling, climbing, diving, railway, bird watching, geopark, aboriginal and other cultural and custom tours.
Li Sixian said that Taiwan is rich in tourism resources, but many foreigners still do not know enough about Taiwan. "They don't even know that there are many high mountains over 3,000 meters in Taiwan." One of the important tasks of the office is to provide information. The Time for Taiwan online Taiwan Pavilion launched by the Tourism Bureau in September is also the focus of publicity.
In order to stimulate the recovery from the international tourism epidemic, the "Business-to-Business" (B2B)-based London Travel Fair will be held this year in a virtual exhibition held on 8 to 9 November. Several Taiwanese tourism companies have participated. Li Sixian said that this year CNBC, Discovery and other media actively requested interviews; with Taiwan’s good reputation for epidemic prevention, the tourism industry can look forward to new opportunities for post-epidemic growth.
(Central News Agency)
News (15)
Japanese professor: warning the CCP to acquire technology from outside
In the Sino-US trade war, China is expected to produce important industries in the CCP's domestic production. In this regard, the Japanese professor pointed out: We must be alert to the CCP stealing foreign technology in the internal loop.
Masahiko Hosokawa, a policy adviser in Aichi Prefecture, Japan, said, "Not only semiconductors, but also China's important industries such as artificial intelligence and numerous electronic component industries. In January, China clearly stipulated the transfer of domestic production, and worked hard to keep important industries such as robots and machinery in China. The CCP focuses on how to obtain technology from foreign countries. The United States has also begun to be wary of this."
Regarding industries such as core components such as electric vehicles, European and American countries have also begun to attach importance to domestic production. Under such an international situation, Professor Hosokawa pointed out that Japan, which plays an important role in this industrial chain, needs to formulate strategic countermeasures.
Masahiko Hosokawa, policy adviser in Aichi Prefecture, Japan: "Japan's important economic policy in the future should be to examine industries in a more precise field, to determine how certain industries should develop, and to ensure that certain technologies will not be leaked."
Professor Hosokawa pointed out that Japan needs to unite countries with common values, such as the United States, Australia, and Europe, to jointly solve the problem of industrial chain crisis.
He said, "Japan and countries that share common values establish specific mechanisms from the very foundation. This is the right direction."
Professor Hosokawa believes that, in addition to this, it is also crucial to make Taiwan one of the most important partners and how to position the Taiwan issue.
News (16)
UK is the first country to approve molnupiravir as the first covid pill
According to Daily Mail, the first at-home pill to treat covid has been approved by Britain's medicines watchdog.
Antiviral molnupiravir was shown in clinical trials to slash the risk of hospitalisation by half in vulnerable and elderly patients.
The tablet - which will be sold under the brand name Lagevrio - will be given twice a day to people within a week of testing positive.
It will be targeted at those who are deemed high risk, including Britons over the age of 60, or patients with heart disease, diabetes, obesity, or other comorbidities.
Health secretary Sajid Javid said the treatment was a 'gamechanger' for the most frail and immunosuppressed, who are vulnerable to Covid even when vaccinated.
The pill is expected to be rolled out on the NHS within weeks, providing the country with an extra layer of defence heading into winter.
Britain has bought 480,000 doses of molnupiravir at a cost thought to be in the region of £250million.
Announcing its approval today, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said the drug was safe and effective
Molnupiravir, made by pharmaceutical giant Merck and its partner Ridgeback Biotherapeutics, works by blocking the virus from replicating in the body.
News (17)
Mixing international vaccines denies Medigen? Scholar criticizes: Basically treat Medigen as water
Editor : Zhang Shizhe
The Central Epidemic Command Center will open the public to vaccinate Medigen MVC COVID-19 Vaccine. If there is an urgent need to go abroad, they can mix with other international vaccines. Some people in Taiwan will have "four doses". Thus this strategy has caused controversy.
In this regard, Wang Renxian, the chairman of the National Defense Epidemiological Society of China, pointed out that Taiwan’s approach fundamentally denies the effectiveness of Medigen, and "treats Medigen as water". So this move is a heavy fight rather than a mixed fight.
According to the “United Daily News” report, Wang Renxian pointed out that there is no problem with vaccination in theory. However, the Central Epidemic Command Center said that if Medigen vaccinators want to go abroad, they have to receive international vaccination.
Wang Renxian said that any vaccine must wait for the previous vaccine's titer to drop before mixing with other vaccines, most of which will take 6 months, because the vaccine will be afraid of the existing antibodies. However, other international vaccines can be given in 28 days for Medigen it is "just treat it as water and deny Medigen." Since the former is denied, of course it will be re-vaccinated later.
Wang Renxian also further pointed out that there are only three doses of the covi vaccine in the world, and Taiwan’s first case of four doses in the world is no longer feasible. Chen Yimin, the convener of the Sustainable Development Group of the Kuomintang think tank, also criticized this. Without empirical data, the command center opened up the Medigen family to re-vaccinate internationally. He said, "That is irresponsible".
News (18)
Taiwanese mixed vaccinating research is out! mRNA in mixed vaccination can reach 100% protection and the pure AZ is less than 20%
Reporter : Ye Weichen
The Central Epidemic Command Centre on 19 November 2021 opens the first dose of AZ vaccine to people who received the first dose of AZ vaccine to make online appointments for mixed BNT vaccine or Moderna vaccine. National Taiwan University Hospital has also completed clinical research on mixed-vaccinating trials a few days ago.
The interim report announced on 19 November that the antibody concentration of the AZ mixed-dose mRNA vaccine is significantly higher than that of the two doses of AZ, and if the protection against Delta is calculated, the mixed-dose or two doses of mRNA can reach almost 100% but the two doses of AZ are only 10-20%.
National Taiwan University Vice President Zhang Shangchun said that the earliest available in our country was the AZ vaccine, but there are actually other vaccines abroad. National Taiwan University wanted to study the effects of mixed administration for a long time. Later, Moderna was added.
At the time of planning, there were already AZ+BNT vaccines in foreign countries. The results were better than AZ+AZ. At that time, they were submitted to the command centre for approval. It happened that the vaccine advisory committee was discussing whether to use AZ+mRNA. The foreign information only saw AZ+BNT but did not see He Mod Nano’s research also successfully received 400 clinical participants.
Sheng Wanghui, an infectious disease physician at National Taiwan University Hospital, reviewed foreign literature. Germany published an article on AZ mixed BNT this year. There were 87 subjects with an average interval of 30 days. The antibody concentration of pure AZ was significantly lower than that of mixed BNT. It is also compared to Wuhan, Britain (Alpha), South Africa (Beta), Brazil (Gamma) virus strains, and the antibody titer for different mutant strains is higher than AZ+AZ.
Another article shows that AZ mixes BNT or Moderna, and the anti-S IgG antibody is almost equal to both doses of mRNA vaccine. It is much higher than two doses of AZ. In addition, the side effects are analyzed when the first dose of AZ vaccine is administered. The side effects are relatively strong, and the side effects of mixed BNT and Moderna in the second dose are relatively high, which is approximately equal to the situation when both doses of the mRNA vaccine are given.
Sheng Wanghui explained the research and design structure of the National Taiwan University Hospital. A total of 400 people were admitted, with an average age of 41 years old. 75% were female subjects. The first dose of AZ vaccine was 300. The first group received AZ 8 weeks apart, and the second group vaccinated Modena at an interval of 8 weeks, the third group were vaccinated with Moderna at an interval of 4 weeks, and the other 100 people were vaccinated with Moderna at an interval of 4 weeks in both doses.
From the results after vaccination, it can be seen that the antibody titer of the S antigen IgG antibody in the mixed group is higher than that of the two doses of AZ, and it can even be maintained for more than 28 days. For the neutralizing antibody part of the Alpha mutant, AZ is also protective, but the potency is still lower than that of the mixed group, and the effect is better when the interval is 8 weeks. The results for the current main mutant Delta are also the same, AZ + Moderna is close to two. The dose of Moderna was higher than two doses of Moderna even 28 days after vaccination. The Delta virus mixed group is also close to 100%.
The estimated protection against Alpha (NT50>1:40) AZ vaccine is 10-20%, and the mixed group can reach almost 100%, the Delta virus mixed group is also close to 100%, and AZ is 10-20%.
As for the side effects, the systemic side effects of mixed vaccinating Moderna are higher than pure vaccinating AZ.
Sheng Wanghui explained the conclusion that mixed vaccination with two doses before and after AZ/Moderna provides a higher immune antibody response than the two doses of AZ/AZ vaccination, and the effect of the two doses of Moderna/Moderna vaccination is equivalent. Mixed AZ/Moderna vaccination has a higher proportion of side effects than A/AZ vaccine, but most of them are mild to moderate transient reactions.
The results of this study show that mixed AZ/Moderna vaccination has a good immune response effect and safety, which is similar to the results of foreign AZ/BNT mixed vaccination. As the virus continues to change, the vaccine's antibody efficacy against the mutant virus may be affected. This study found that the neutralizing antibody effect for the Delta mutant strain is lower than that for the Alpha mutant strain.
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