New Taipei City on Friday launched a trial program to monitor and care for people at risk of unknowingly developing abnormally low blood oxygen levels, amid reports of people with COVID-19 dying from the condition. The program, implemented at the direction of New Taipei City Mayor Hou You-yi (侯友宜), has selected 60 people for a trial, during which participants provided with thermometers and oximeters would upload data on their condition to a platform for monitoring, the city government said. Should the program prove successful, it would be expanded to include city residents confirmed to have COVID-19, it said. The platform monitors participants’ temperatures and blood oxygen concentration, and contacts them twice a day to ensure they are hospitalized quickly if they should need it, Hou said. New Taipei City Department of Health Director Chen Jun-chiu (陳潤秋) said that 11.8 percent of recorded COVID-19 deaths have been linked to silent hypoxemia. Normal blood oxygen concentration should be at least 95 percent, she said, adding that the mortality rate for people with blood oxygen concentration of 93 to 94 percent within five days is 2.24 percent. The mortality rate for people with blood oxygen concentration of 92 percent or less within five days is 14.33 percent, she added. People should seek medical attention immediately after being diagnosed with lower than normal blood oxygen concentration levels, Chen said. The department has only received 4,200 of 15,000 oximeters that the central government has committed to provide to the program, it said, adding that it is looking to purchase more oximeters. Chung Shan Medical University Hospital doctor of general medicine Chen Hsin-mei (陳欣湄) said on Facebook on Tuesday that people who have difficulty breathing or who have a blood oxygen level of 94 percent or less after contracting COVID-19 might be able to relieve their symptoms by lying face down, but should prepare to
The Chinese Christian Relief Association yesterday called on people to join a fundraising campaign for delivering necessities to underprivileged families, as many are struggling during the COVID-19 outbreak. After a level 3 COVID-19 alert was implemented nationwide on May 19, the association’s 1919 Food Bank, TSMC Charity Foundation, convenience store chain 7-Eleven and its Good Neighbor Foundation partnered to launch a digital fundraising campaign through 7-Eleven’s platforms. The campaign funds food packages that contain rice, oil, dried noodles and canned food, with each package costing NT$300, the association said in a news release. About 6,000 such packages have already been delivered to children in the association’s study assistance program, it said. The association began accepting applications from other people from Tuesday last week, and plans to send out 4,000 packages containing food, noodles, masks and soap, it said. More than 70 percent of the people who need help are unemployed due to COVID-19, while 19 percent of applications came from New Taipei City, data from the association’s 1919 Food Bank showed. About 20 percent only have odd jobs and 16 percent have been receiving aid from social welfare institutions, while 14 percent were vendors or shopkeepers, or working in the food and beverage sector, the data showed. The association said that a woman surnamed Su (蘇), who has been living with her parents and two children in Tainan after getting divorced, used to work at an industrial plant during the day and had another part-time service job in the evening, while her father worked odd jobs. However, Su lost her part-time job due to COVID-19 and her father lost his jobs, dealing another blow to an already fragile family livelihood, the association said. Another woman grows honey peaches with her husband in Taoyuan’s Fusing District (復興), a mountainous area known for peaches and tourist attractions, it said. They
APPROVAL REQUIRED: The CPBL hopes to restart pro baseball by the first week of next month at the latest, as players are worried that the season will end too late
The Chinese Professional Baseball League (CPBL) hopes to resume this year’s Taiwan pro baseball season with a proposal to play games in strict “bubbles” in the south of the country. CPBL officials have drafted a plan to submit to the Central Epidemic Command Center (CECC) next week for review, sources said. CPBL games were suspended on May 15, along with amateur baseball and school leagues. Due to an increase in the number of domestic COVID-19 cases, the center on May 15 imposed a level 3 alert on Taipei and New Taipei City, and four days later it was expanded to the entire nation. The alert has been extended to June 28. Indoor gatherings of more than four people and outdoor gatherings of more than nine are banned, while schools and many public venues have been closed and people have been advised to stay at home. The CPBL is hoping to resume games at the end of the month or in the first week of next month if the plan is approved, sources said. Under the plan, all games in Taipei and New Taipei City would be canceled, as the two municipalities remain COVID-19 hotspots. The CPBL’s plan would have each team moving together as one group, with their own buses taking them from their hotel to the ballpark, sources said, adding that no visitors would be permitted and outside contact would be minimized. The plan proposes that games be played without fans, with workers and grounds crews kept to a minimum, and no members of the media allowed, sources said. As there is no restart date yet for this season, Uni-President Lions Manager Lin Yueh-ping (林岳平) on Friday said that the players’ main concern is that the playoffs would be pushed to November or December. “That would take quite a heavy toll on the players’ bodies... Normally when we get
Prosecutors yesterday filed attempted murder charges against a New Taipei City man accused of stabbing three nurses at the city’s Shuang Ho Hospital where he was quarantined for COVID-19. The New Taipei City District Prosecutors’ Office in a news release cited the wounds the man surnamed Hung (洪) allegedly inflicted as evidence of his intent to kill and indifference to human life. Prosecutors are also asking the court to indict the man on charges of assault, aggravated assault and obstructing the Medical Care Act (醫療法), the office said. Hung was admitted to the hospital’s COVID-19 quarantine facility on May 25, three days after feeling weak and testing positive for the virus, it said. On Monday morning last week, he left quarantine without authorization before being confronted by two nurses surnamed Tsai (蔡) and Chen (陳), who compelled him to return to the quarantine area, the office said. Later, Hung hid a fruit knife behind his back and went to the hospital’s solarium, where he approached a nurse surnamed Shih (施) and asked her for directions to leave the facility, it said. When Shih refused, Hung allegedly stabbed her in the chest and back until she retreated to a hospital corridor crying for help, the office said. When Tsai and Chen came to investigate, Hung allegedly attacked them. Tsai dodged a thrust that glanced across her abdomen before helping Shih to escape, but Hung allegedly cornered Chen and repeatedly stabbed her in the chest and the groin, it said. After the police subdued Hung, he spat at medical staff, the office added. Shih’s life-threatening injuries included a collapsed left lung. The nerves and tendons in Chen’s right hand were severed while she was defending herself, and she had other non-life-threatening injuries. The New Taipei City District Court has been asked to impose a heavy sentence due to the viciousness of the
Remote learning can place increased strain on children’s eyes and parents should supervise the amount of time they spend in front of a screen during the COVID-19 pandemic, a Hsinchu-based ophthalmologist said. Taiwan’s level 3 COVID-19 alert means that schools nationwide remain closed and have shifted to online classes. Chen Ying-shan (陳瑩山), a doctor at China Medical University Hospital’s Hsinchu Branch, said that he recently treated a high-school student whose sight declined from minus-1.5 to minus-3.5 diopters since the COVID-19 outbreak began. The child had been learning from home and spent too much looking at screens, which created tension in the ciliary muscles and an overabundance of blood in the eye tissue, he said. This can result in worsening myopia, fatigue and soreness of the eyes, he said, adding that eye drops taken nightly relieved the soreness the student was experiencing, while rest might reverse some of the vision loss. A child learning from home should take a 10-minute break for every 30 minutes of online classes and should be made to leave their desks, do eye exercises, stretches and walk around the home, he said. Resting the eyes means not using devices with screens, especially cellphones, which have a smaller screen than computers and are more tiring on the eyes, he said. Lutein, which is found in leafy greens and egg yolks, is good for the eyes, he said, adding that about 6 to 10mg should be ingested per day, or about the amount contained in a bowl of spinach. Moderate amounts of protein and five types of fruits and vegetables should be eaten daily, and deep-fried foods should be avoided, he said, adding that trans fats can harm eye health by hardening the blood vessels.
HEALTH CONCERNS: Medical research showed that pregnant women benefit from mRNA vaccines, and are at risk while visiting hospitals for testing, legislators said
Legislators yesterday urged the Central Epidemic Command Center (CECC) to give pregnant women and healthcare workers caring for them priority to receive messenger RNA (mRNA) COVID-19 vaccines. Legislators from various parties urged the center to add pregnant women to its COVID-19 vaccine priority list, with Democratic Progressive Party Legislator Kao Chia-yu (高嘉瑜) citing Taiwan Association of Obstetrics and Gynecology reports that pregnant women would best benefit from receiving mRNA vaccines, specifically the Moderna or Pfizer-BioNTech vaccines. Taiwan Statebuilding Party Legislator Chen Po-wei (陳柏惟) cited a New England Journal of Medicine article that said that contracting COVID-19 could affect a fetus, and recommended that the Moderna vaccine be administered to pregnant women, including those with a history of autoimmune diseases or thrombosis. The exclusion of pregnant women puts their health at great risk, independent Legislator Chao Cheng-yu (趙正宇) said, adding that it would be difficult to separate women undergoing prenatal exams from other high-risk groups in a hospital. Chao, without citing a source, said that research has shown that pregnant women who have contracted COVID-19 are at a higher risk of stillbirths or premature births, adding that mRNA vaccines, considered safer for pregnant women, should be administered to them as well as their healthcare workers. Chinese Nationalist Party (KMT) caucus whip Alex Fai (費鴻泰) cited statements from gynecology associations saying that pregnant women should receive mRNA vaccines, provided that there is sufficient supply. The legislature is asking the Ministry of Health and Welfare to put pregnant women on the priority list for mRNA vaccines, he said. Separately, the nation is next week to start administering 1.24 million doses of the AstraZeneca vaccine received last week as a donation from Japan. People eligible to be inoculated can register at hospitals administering the vaccines, or online a week in advance or using kiosks at four major convenience store chains, the CECC
MAKING CONNECTIONS: Although not the first to issue an EUA before phase 3 trials, Taiwan could be the first to do so with a method known as immunobridging
Taiwan’s approach to evaluating the efficacy of COVID-19 vaccine candidates has not been used by any other country as a basis for granting emergency use authorization (EUA), Minister of Health and Welfare Chen Shih-chung (陳時中) said on Friday. During a legislative hearing, Taiwan People’s Party Legislator Ann Kao (高虹安) questioned Chen about review standards for issuing EUAs for domestic COVID-19 vaccines, which the Food and Drug Administration (FDA) published on Thursday. While Taiwan’s domestically developed vaccine candidates have completed phase 1 and 2 clinical trials, none of them have begun larger phase 3 trials — which are typically the standard for determining efficacy. FDA guidelines allow EUAs to be issued without phase 3 trials, by instead analyzing phase 2 results through immunobridging, which uses the immune response measured in clinical trial participants to infer the overall level of protection a vaccine would provide. Critics say that this approach, which is based on the potency levels of neutralizing antibodies found in clinical trial participants, cannot be used to accurately determine a vaccine’s efficacy. Kao asked Chen whether Taiwan would be the first country to grant an EUA using immunobridging as a substitute for efficacy data obtained in phase 3 clinical trials. Initially, Chen said that he could not speak to the approaches being adopted by regulators in other countries, adding that immunobridging has been a topic of discussion in the WHO. When pressed, Chen said that “there are currently no approvals of this type.” “If that is the case, then this is genuinely frightening,” Kao said. “Taiwan has purchased 10 million [local] vaccines, enough to give to 5 million people.” “If the efficacy of the domestic vaccines does not meet expectations, then these people are like the emperor with no clothes — completely without protection,” she said. Russia and China have approved COVID-19 vaccines for use before they entered phase
A person who was on Friday reported as the first in Taiwan to die after receiving a COVID-19 vaccine died of a heart attack, a Central Epidemic Command Center (CECC) official said yesterday. The deceased, whose sex and age were not disclosed, had coronary artery disease, which led to a fatal heart attack, Centers for Disease Control Deputy Director-General Chuang Jen-hsiang (莊人祥), who is the CECC’s spokesman, told a news conference, citing the autopsy report. It was the first death listed as a possible adverse event after receiving the AstraZenenca COVID-19 vaccine since the start of the vaccination program on March 22. The person had a history of stroke and cirrhosis, and was undergoing kidney dialysis, the CECC said in a statement on Friday. They developed a dry cough two days after receiving the first dose of the vaccine, and later a diminished appetite, sore neck, nausea and constipation, the CECC said. The discomfort lasted until the sixth day after the vaccination, when they vomited in the morning and lost consciousness at about noon, it said. The person was rushed to a hospital, but was pronounced dead before arriving, the CECC said, adding that they tested negative for COVID-19. The center reported no new adverse events yesterday. As of Friday, it had reported 1,061 incidents involving COVID-19 vaccine recipients experiencing side effects or allergic reactions, with two related to the Moderna vaccine, the rollout of which began on Wednesday.
Limited testing, elderly patients and overflowing hospitals could be responsible for Taiwan’s higher than average COVID-19 case-to-fatality ratio, National Taiwan University Hospital doctor Lee Chien-chang (李建璋) said on Wednesday. The number of COVID-19 deaths in Taiwan has risen to 411, including 399 since May 15, Central Epidemic Command Center data released yesterday showed. The nation’s death rate from COVID-19 among confirmed cases is higher than the 2.14 percent global average. Lee, a Harvard University-trained epidemiologist and doctor of emergency medicine, said that the rate in Taiwan is likely to climb to about 3 percent. Mortality rates among confirmed cases are dependent on testing capacity. More COVID-19 testing uncovers more nonfatal cases, which lowers the result of a deaths-to-cases calculation, Lee said. The US and the UK — countries with which Taiwan compares unfavorably in terms of deaths among cases — had earlier outbreaks and therefore more time to build robust testing capacity, he said. The US and the UK each have tested about 5,000 people in 1 million, while Taiwan tests about 1,000 in 1 million, which leads to light and asymptomatic cases going underreported, he said. As health authorities in Taiwan detect severe cases more reliably than light ones, the death rate is artificially higher, he said. Missing light cases is a warning sign that suggests Taiwan has a serious gap in its capability to battle the pandemic, he said, adding that tests must be improved to keep up with the virus’ spread. Age is another important factor in mortality, Lee said. Of confirmed cases in Taiwan, 8.35 percent are people aged 70 or older, higher than the global average of 5.36 percent, he said. However, people older than 70 account for 9.73 percent of confirmed cases in the US, which has a lower mortality rate among confirmed cases, suggesting that more issues are at play than the ratio of
The Central Epidemic Command Center (CECC) has ordered a monoclonal antibody-based drug to treat mild to moderate cases of COVID-19, which it expects to receive by the middle of the month, it said on Friday. Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the CECC, announced the drug purchase, but did not identify the medicine or how many doses had been purchased. A CECC news release indicated that the shipment would have enough doses to treat 1,000 people. The drug would be used to treat people with mild to moderate symptoms of COVID-19 who are at high risk of developing more serious symptoms, to lower their risk of becoming seriously ill and requiring hospitalization, Chen said. The drug would be distributed to hospitals that also serve as quarantine centers, the CECC said, adding that patients would be treated with the combination of medicines after a physician’s diagnosis. Citing international studies, Chen said that the number of people with COVID-19 who have mild symptoms accounted for about 80 percent of the total cases. About 9 percent of such patients can become seriously ill, but this is often as a result of risk factors such as old age, obesity, chronic kidney failure, cardiovascular disease, high blood pressure, chronic lung disease, immunosuppression disorders and pregnancy, he said. As the domestic outbreak remains strong and is pushing medical resources for severe cases to the brink, the CECC decided to introduce the monoclonal antibody-based drug after obtaining evidence of its efficacy and safety in treating moderate or mild cases of COVID-19, he said. The US Food and Drug Administration and some other countries have issued emergency use authorization for clinical use of anti-SARS-CoV-2 monoclonal antibodies in treating mild to moderate cases of COVID-19 in nonhospitalized patients. The US gave approval to Regeneron Pharmaceuticals’ antibody cocktail of casirivimab plus imdevimab in November last
Chinese Nationalist Party (KMT) Chairman Johnny Chiang (江啟臣) yesterday demanded that Minister of Health and Welfare Chen Shih-chung (陳時中) be replaced as head of the Central Epidemic Command Center (CECC), saying that the epidemic prevention team could no longer lead the public out of the COVID-19 pandemic. Chiang made the remarks in a video a day after President Tsai Ing-wen (蔡英文) said in an online speech that the government would make constant adjustments to its “anti-pandemic battle formations to ensure Taiwan is not beaten by the virus.” The KMT has repeatedly urged Tsai to use a different official to lead the government’s COVID-19 response, Chiang said, adding that the head of the CECC must be able to work with local officials in addition to having public health credentials. The government’s decision to relax quarantine protocols for China Airline’s pilots in April caused the current virus outbreak, he said, adding that Deputy Minister of Health and Welfare Shih Chung-liang’s (石崇良) comments that Taipei’s Wanhua District (萬華) was “the gap in [Taiwan’s] anti-pandemic defenses” blames the people for the government’s failure. Health officials had resolved to loosen COVID-19 travel restrictions for pilots without leaving a record of their discussions on the matter, which showed their arrogance, self-satisfaction and an inability to stand up to Chen, Chiang said. Regarding the development of domestic COVID-19 vaccines, Chiang said that while the public would be willing to use local vaccines, the government is still responsible for explaining why doses were ordered at high prices, how effective the vaccines are and if they would be certified by the WHO. “Tsai said that she would receive a domestic vaccine, and I believe the Cabinet would lead the country by example in this,” Chiang said. “But the people want to know about the domestic vaccines’ potency, efficacy, competitiveness and international certification, not see superficial
EXPANDING OPTIONS: New Taipei City yesterday also announced that drivers could deliver meals and goods, a decision that local unions welcomed amid a virus alert
Taipei taxis are allowed to double as meal and cargo delivery vehicles during level 2, 3 or 4 COVID-19 alerts, Taipei Mayor Ko Wen-je (柯文哲) said on Thursday. However, taxi drivers would have to follow industry accepted pricing and not use cab meter rates, he said. The announcement came after Taipei Professional Drivers’ Union president Cheng Li-chia (鄭力嘉) said that Taipei should find ways to help taxi drivers deal with fewer passengers amid the level 3 alert started last month, citing the Kaohsiung City Government’s move to allow taxi drivers to deliver meals for restaurants. Taipei City Dynamic Taxi Industry Union president Hu Wei-cheng (胡偉成) welcomed Ko’s announcement, but said that the city government should consider allowing taxis making deliveries to be considered as cargo vehicles, which would allow them to park in delivery and loading zones. New Taipei City Department of Transportation Director Chung Ming-shih (鍾鳴時) yesterday said that the city was also allowing taxis to deliver meals and cargo during the pandemic, effective yesterday. This would facilitate transportation for the logistics industry, give taxi drivers an additional source of income and help stores sell goods through online platforms, Chung said. Some taxi drivers have chosen to stop working during the pandemic, but many say they cannot, as they have to support their families. “There are just no people around, even if we drive around for 10 hours a day,” a driver said. Cheng on Tuesday said that some union members told him that they only managed to pick up a passenger after five or six hours on the job, and the fares — sometimes little more than NT$100 — were not enough to cover fuel costs. Taxi drivers did not receive fuel stipends this year, Cheng said, adding that even if there were stipends, many drivers would rather rely on their earnings than government subsidies. Taiwan has been
The Ministry of Labor on Tuesday temporarily exempted four key industries from a law mandating that workers receive a minimum of 11 hours rest between shifts, citing the country’s ongoing COVID-19 outbreak. Under the policy, the minimum time between shifts for workers in the manufacturing, wholesale, general retail and warehousing sectors would be shortened to eight hours, as opposed to the 11 hours mandated by the Labor Standards Act (勞動基準法), the ministry said. The move, which applies to an estimated 490,000 workers, would remain in effect until Taiwan’s level 3 COVID-19 alert is lifted, it said. The national level 3 alert, announced on May 19 and extended through June 28, was imposed in response to a COVID-19 outbreak that started in the middle of last month. One byproduct of the outbreak has been a spike in online shopping and demand for staple products, which has in turn placed significant strain on home delivery services, as well as retailers such as supermarkets and their supply chains. The ministry’s announcement follows a decision it made last month to lift limits on overtime work for manufacturing, logistics and retail workers, under special guidelines related to emergency situations. Department of Labor Standards and Equal Employment Director Huang Wei-chen (黃維琛) said that the new policy is intended to give industries flexibility in scheduling to meet increased demand. Companies that wish to use the new guidelines must first obtain permission from their employees, either through labor-management meetings or labor unions, while companies with more than 30 employees must also notify the local government, Huang said.
Two employees at Next TV in Taipei have tested positive for COVID-19 during on-site screening, following the death of a camera operator at the broadcaster, the city government said yesterday. Over the past two days, 355 workers at the media organization have been tested, while two who have been confirmed as infected have entered quarantine at a government-designated facility, the city government said. On Wednesday, the city set up a testing station at the Next TV compound in Neihu District (內湖) after a camera operator was found dead in the station’s office building and a postmortem COVID-19 test confirmed that he had contracted the disease. As of yesterday, Next TV had not released any information about the two new cases, but other local media reported that they were a camera operator and a satellite newsgathering technician. The Next TV trade union said in a statement yesterday that it had not been informed of the latest infections, and many of its members have had to rely on media reports for information about the COVID-19 situation in the company. The statement followed a call by the union on Wednesday for Next TV to guarantee the wages of infected employees and that contacts who have to go into quarantine or self-isolation. The company said that it was not withholding information about the latest COVID-19 developments among its staff, adding that it has been asked to take preventive measures while awaiting instructions from the city government. Fifteen non-governmental organizations and trade unions representing journalists and other media workers in Taiwan issued a joint statement on Wednesday, urging the government to include frontline media workers on the priority list for COVID-19 vaccination.
OUT OF SHAPE: Gyms have also faced losses, with Taipei Gym saying it would close one of its locations, while World Gym tries online classes
Revenues at hair salons in Taipei have declined 70 percent under a prolonged level 3 COVID-19 alert, an association for hairdressers and cosmetologists said on Tuesday, calling for government help to support workers. The alert was first applied to Taipei and New Taipei City on May 15, and four days later it was expanded to the entire nation. On Monday, the Executive Yuan announced that the alert would be extended until June 28. The government does not require that hair and beauty salons close, but asks that their employees wear masks, register clients’ contact information, check people’s temperatures and regularly disinfect their hands. However, many Taipei salons have suspended operations out of fear of virus transmission due to employees’ close contact with clients. Although hairdressers do not touch clients’ faces and have adopted preventive measures, revenues at hair salons have fallen 70 percent, said Chen Kuei-mei (陳貴梅), secretary-general of a union representing hairdressers and cosmetologists. Salons have to pay rent and utility bills even without clients, while stylists, who rely on commission from their work, cannot make a living without clients, she said. Chen called on the government to support the industry’s workers by providing subsidies or loans to help them get through the pandemic. Many fitness clubs have also suspended operations since last month. Taipei Gym on May 25 announced that its stores on Taipei’s Xinsheng S Road Sec 3 and in New Taipei City’s Yonghe District (永和) would be temporarily closed until Monday next week. However, the gym last week announced that due to the pandemic, it would close its Xinsheng location at the end of the month, adding that paid members could apply for refunds until July 31. Having operated for more than a decade, Taipei Gym counted Taiwanese weightlifter and Olympic gold medalist Hsu Shu-ching (許淑淨) among its customers. Another fitness chain, World Gym, said it
Nantou County, one of the nation’s biggest producers of flowers, has called on the government to provide subsidies, as prices have plummeted in the absence of graduation ceremonies and banquets, amid a water shortage. Puli Township (埔里) has 400 hectares dedicated to cultivating flowers, which is estimated to bring in NT$2 billion (US$72.38 million) in profit per year. While late seasonal plum rains would have reduced losses for farmers, a COVID-19 outbreak that started last month has led to the cancelation of graduation ceremonies and banquets, farmers said. The ceremonies and banquets usually make up the majority of flower sales during this time of the year, they said. One farmer, surnamed Juan (阮), said that a bouquet of roses would be on the high end sold for NT$50 to NT$60 per bouquet at the wholesale market, and NT$30 to NT$40 on the low end. Sales this year would not even cover overhead costs, Juan said, adding that farmers are also concerned that the pandemic would continue through the next flowering season. Another farmer, surnamed Nai (乃), said that the overheads on a 293.4 ping (970m2) plot of land could be as much as NT$200,000. Nai, who owns 6,789m2 of land, said that he had decided not to harvest roses this year, as he stands to lose more than NT$1 million. Growers of fruit, such as papaya and passion fruit, have also filed for natural disaster subsidies, Puli Township Mayor Liao Chih-cheng (廖志城). The county government is today to survey the potential losses, and the township would ask that any subsidies include the flower industry, he said. Sales of Texas bluebells have also fallen due to the pandemic. The flower is often exported to Japan, especially during the winter, when the cold weather prevents it from being grown in Japan. Chiayi County’s Singang Township (新港) contributed nearly 20 percent of total exports of
‘FALL-BACK OPTION’: The National Policy Foundation said that because Taiwanese vaccines are not fully tested, they should only be used as a backup for foreign ones
The Chinese Nationalist Party (KMT)-affiliated National Policy Foundation yesterday questioned the safety and effectiveness of COVID-19 vaccine candidates from Medigen Vaccine Biologics Corp, citing a lack of phase 3 trials. Foundation deputy director Huang Hsin-hua (黃心華) made the remarks in an online news conference a day after Medigen unblinded data from its phase 2 trials. Although Medigen increased the sample pool of subjects in its phase 2 clinical tests in a bid to secure emergency use authorization, an expanded phase 2 is no substitute for phase 3 trials, Huang said. The lack of phase 3 studies sets the Taiwan-made vaccines apart from those that have obtained international certifications, he said, adding that the nation should use its vaccines only as a backup to imported ones. United Biomedical Inc, the other local firm developing a COVID-19 vaccine, has said it expects to complete the unblinding process this month. The government has ordered 5 million doses each from Medigen and United Biological. As indigenous vaccines are not fully tested, Taiwan should use them as a backup for when better-proven vaccines are not available, Huang said. Vaccine evaluation, procurement and distribution are processes that should be regulated by professionalism, which government officials have failed to display, he said. The government should show more transparency, use accredited evaluators and keep full records when evaluating domestically developed vaccines for emergency use, Huang added. “It was curious that Medigen’s principal investigator was not at the conference to unblind the trials,” said former KMT legislator Arthur Chen (陳宜民), who was formerly vice president of Kaohsiung Medical University. Chen asked why the government ordered vaccines before trials were unblinded and why the emergency use authorization criteria were announced by the Food and Drug Administration only a few hours before Medigen published its data. Medigen’s and United Biomedical’s vaccines are designed around strains of the virus found in Wuhan, China,
There must be caution in the distribution of COVID-19 vaccines developed by Medigen Vaccine Biologics Corp and United Biomedical Inc before their phase 3 trials are conducted, former Centers for Disease Control director Su Ih-jen (蘇益仁) said on Monday. Su’s comment came a day after Chinese-language media reported that Academia Sinica research fellow Chen Pei-jer (陳培哲) quit a Food and Drug Administration advisory committee to protest the government’s vaccine authorization plans. Chen said he resigned late last month because he felt that the committee would have trouble remaining neutral when reviewing domestic vaccine candidates, with the major challenge to neutrality posed by President Tsai Ing-wen (蔡英文) herself after expressed hope that a locally developed COVID-19 vaccine would be available late next month. Su, a former convener of the Cabinet’s vaccine technology development committee, said that “products that are not certain to be authorized for use or still far from it should certainly not be used in mass inoculation programs.” Medigen and United Biomedical vaccines, of which the government has ordered 5 million doses each, are not expected to be subjected to phase 3 trials before obtaining emergency authorization, he said. The Taiwanese firms are using additional test subjects and antibody counts in phase 2 trials in place of efficacy studies that typically are part of phase 3 trials, he said. The measures are not enough to guarantee that the domestic vaccines will be fully effective, so they should not comprise the main part of Taiwan’s inoculation program, he said. Although Pfizer, Moderna, AstraZeneca and Johnson & Johnson vaccines were granted emergency use authorizations, the manufacturers had carried out phase 3 trials, demonstrating their readiness for use, he said. No more than 1 million people should receive domestic vaccines and only as a supplement to the more proven vaccines that the government must obtain from foreign sources, he said. Should
‘SECOND BEST’: A researcher said that as phase 3 vaccine trials could take several years, it would be best for Taiwan to use the vaccines based on the phase 2 results
Phase 2 clinical trial results of a COVID-19 vaccine developed by Medigen Vaccine Biologics Corp generated good data, experts said, although they warned that there was still no way to know how effectively it would prevent the disease. “Data look quite good,” Academia Sinica researcher Michael Lai (賴明詔) said on Thursday after Medigen announced that its vaccine candidate had shown no major safety concerns. The data showed that the vaccine produced sufficient neutralizing antibodies and as long as there were antibodies, there should be protection, Lai said, adding that its toxicity was low. The Medigen vaccine has achieved the goals of creating sufficient neutralizing antibodies and having low toxicity, but only phase 3 trials could determine if it actually protects people who receive it, said Lai, who is a virologist and a coronavirus researcher. There are many ways to produce vaccines, including via protein subunits such as the one Medigen is working on, he said. The most traditional way is to use the virus to produce a vaccine with several proteins that the immune system recognizes should not be there, triggering an immune response, he said. However, this method can produce a level of toxicity, he said. A protein subunit vaccine has only one protein, in this case a spike protein, he said. “It is purer, but could trigger a weaker immune reaction,” Lai said. “Different vaccine production methods have different advantages and disadvantages. One cannot be compared to another.” It could take several years for a domestic vaccine to go through phase 3 trials, so given Taiwan’s situation, “it should opt for second-best,” even though major vaccines made elsewhere in a matter of months obtained enough efficacy data in phase 3 trials to get emergency use authorization (EUA), he said. It would be acceptable for Medigen to apply for EUA with only the results of its phase 2 trials,
Prominent businesspeople and figures in entertainment yesterday said that they were on a list and had been vaccinated for COVID-19 at a Good Liver Clinic (好心肝診所) branch in Taipei. PChome Online Inc chairman Jan Hung-tze (詹宏志) said that he was on the list and had received the vaccination at one of the clinic’s branches, as did TV and radio host Alvin Hou (侯昌明), actors Kuo Tzu-chien (郭子乾) and Jamie Weng (翁家明), and iQiyi executive Young Min (楊鳴). Judicial personnel are investigating alleged breaches of the law amid a public outcry over the vaccinations, which the clinic said were conducted in the belief that all of Taipei’s healthcare workers had been inoculated. Critics said that the clinic had favored “wealthy and famous” people to receive its allocation of AstraZeneca vaccines, which would be a breach of Central Epidemic Command Center (CECC) policy to prioritize frontline medical personnel, police and emergency-response workers, among others. Lists published online have been claimed to be of names of those in line to receive vaccines at the clinic. Taipei Mayor Ko Wen-je (柯文哲) said that he had handed a list, apparently of names of people who Good Liver Clinic had vaccinated, over to prosecutors. Prosecutors on Thursday questioned clinic director Sheu Jin-chuan (許金川) and 11 others, and searched clinic offices, as well as Taipei Department of Health offices. Prosecutors said that corruption charges would be brought if evidence shows that health officials colluded with the clinic to obtain extra allotments of vaccines through falsified requisitions. The Taipei Medical Association condemned the Taipei City Government in a press release. “At the time this was written, more than 5,000 medical personnel at Taipei hospitals and clinics have not received jabs, but Good Liver Clinic was provided with vaccines to inoculate people affiliated with its office and even members of the public,” the statement said, demanding that