Former Chinese Nationalist Party (KMT) vice chairman Hau Lung-bin (郝龍斌) is to appeal the Food and Drug Administration’s (FDA) authorization of Medigen Vaccine Biologics’ COVID-19 vaccine, he said yesterday.
The administration on July 19 granted Medigen emergency use authorization, even though the drugmaker had not yet completed phase 3 clinical trials.
The government should not authorize the use of a vaccine that has not completed phase 3 trials, Hau said in Taipei on the sidelines of an event to distribute boxed meals with former president Ma Ying-jeou (馬英九) and Broadcasting Corp of China chairman Jaw Shaw-kong (趙少康).
Photo: Fang Pin-chao, Taipei Times
Hau said the government had politicized science in its hasty approval of a domestically developed COVID-19 vaccine.
The emergency use authorization of a vaccine prior to the completion of phase 3 trials is unprecedented, as it means a vaccine’s efficacy has not been verified, he said, adding that President Tsai Ing-wen (蔡英文) and Vice President William Lai (賴清德) have set a poor example in saying they would take the Medigen vaccine.
“The government should spare the lives of the Taiwanese people,” he said.
Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the Central Epidemic Command Center, yesterday said that the center respects the right of citizens to file petitions related to the authorization.
Medigen is the only Taiwanese company to which the FDA has granted emergency use authorization.
The administration said it based its decision on data Medigen obtained in a phase 2 clinical trial of about 4,000 participants earlier this year, which was analyzed through immunobridging and compared with a control group of 200 recipients of the AstraZeneca COVID-19 vaccine in Taoyuan.
Immunobridging is a method to infer the efficacy of a vaccine by comparing the concentration of neutralizing antibodies in each group of recipients with that of an approved vaccine.
Medigen on July 20 announced that it had received permission to conduct a 1,000-person phase 3 clinical trial in Paraguay for its COVID-19 vaccine.
Participants in the trial, to be held with the National University of Asuncion’s medical school, would be recruited in the third quarter of this year and Medigen expects to have interim analysis data in the fourth quarter, the company said.
The trial would compare recipients of the Medigen and AstraZeneca vaccines through immunobridging, it said.
Medigen did not elaborate on its reasons for holding such a small trial or its use of immunobridging, which has been criticized as an insufficient substitute for traditional efficacy data.
Taiwan has agreed to buy 10 million doses of COVID-19 vaccines from two Taiwanese manufacturers: Medigen and United Biomedical, which has not yet been granted emergency use authorization by the FDA.
ANOTHER EMERGES: The CWA yesterday said this year’s fourth storm of the typhoon season had formed in the South China Sea, but was not expected to affect Taiwan Tropical Storm Gaemi has intensified slightly as it heads toward Taiwan, where it is expected to affect the country in the coming days, the Central Weather Administration (CWA) said yesterday. As of 8am yesterday, the 120km-radius storm was 800km southeast of Oluanpi (鵝鑾鼻), Taiwan’s southernmost tip, moving at 9kph northwest, the agency said. A sea warning for Gaemi could be issued tonight at the earliest, it said, adding that the storm is projected to be closest to Taiwan on Wednesday or Thursday. Gaemi’s potential effect on Taiwan remains unclear, as that would depend on its direction, radius and intensity, forecasters said. Former Weather Forecast
As COVID-19 cases in Japan have been increasing for 10 consecutive weeks, people should get vaccinated before visiting the nation, the Centers for Disease Control (CDC) said. The centers reported 773 hospitalizations and 124 deaths related to COVID-19 in Taiwan last week. CDC Epidemic Intelligence Center Director Guo Hung-wei (郭宏偉) on Tuesday said the number of weekly COVID-19 cases reported in Japan has been increasing since mid-May and surpassed 55,000 cases from July 8 to July 14. The average number of COVID-19 patients at Japan’s healthcare facilities that week was also 1.39 times that of the week before and KP.3 is the dominant
The Chinese Communist Party’s (CCP) working group for Taiwan-related policies is likely to be upgraded to a committee-level body, a report commissioned by the Mainland Affairs Council (MAC) said. As Chinese President Xi Jinping (習近平) is increasingly likely to upgrade the CCP’s Central Leading Group for Taiwan Affairs, Taiwanese authorities should prepare by researching Xi and the CCP, the report said. At the third plenary session of the 20th Central Committee of the CCP, which ended on Thursday last week, the party set a target of 2029 for the completion of some tasks, meaning that Xi is likely preparing to
US-CHINA TRADE DISPUTE: Despite Beijing’s offer of preferential treatment, the lure of China has dimmed as Taiwanese and international investors move out Japan and the US have become the favored destinations for Taiwanese graduates as China’s attraction has waned over the years, the Ministry of Labor said. According to the ministry’s latest income and employment advisory published this month, 3,215 Taiwanese university graduates from the class of 2020 went to Japan, surpassing for the first time the 2,881 graduates who went to China. A total of 2,300 graduates from the class of 2021 went to the US, compared with the 2,262 who went to China, the document showed. The trend continued for the class of 2023, of whom 1,460 went to Japan, 1,334 went to