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.
A fugitive in a suspected cosmetic surgery fraud case today returned to Taiwan from Canada, after being wanted for six years. Internet celebrity Su Chen-tuan (蘇陳端), known as Lady Nai Nai (貴婦奈奈), and her former boyfriend, plastic surgeon Paul Huang (黃博健), allegedly defrauded clients and friends of about NT$1 billion (US$30.66 million). Su was put on a wanted list in 2019 when she lived in Toronto, Canada, after failing to respond to subpoenas and arrest warrants from the Taipei District Prosecutors’ Office. Su arrived at Taiwan Taoyuan International Airport at 5am today on an EVA Air flight accompanied by a
A 79-year-old woman died today after being struck by a train at a level crossing in Taoyuan, police said. The woman, identified by her surname Wang (王), crossed the tracks even though the barriers were down in Jhongli District’s (中壢) Neili (內壢) area, the Taoyuan Branch of the Railway Police Bureau said. Surveillance footage showed that the railway barriers were lowered when Wang entered the crossing, but why she ventured onto the track remains under investigation, the police said. Police said they received a report of an incident at 6:41am involving local train No. 2133 that was heading from Keelung to Chiayi City. Investigators
The Keelung District Prosecutors’ Office today requested that a court detain three individuals, including Keelung Department of Civil Affairs Director Chang Yuan-hsiang (張淵翔), in connection with an investigation into forged signatures used in recall campaigns. Chang is suspected of accessing a household registration system to assist with recall campaigns targeting Democratic Progressive Party (DPP) city councilors Cheng Wen-ting (鄭文婷) and Jiho Chang (張之豪), prosecutors said. Prosecutors yesterday directed investigators to search six locations, including the Chinese Nationalist Party’s (KMT) Keelung office and the residences of several recall campaign leaders. The recall campaign leaders, including Chi Wen-chuan (紀文荃), Yu Cheng-i (游正義) and Hsu Shao-yeh
COVID-19 infections have climbed for three consecutive weeks and are likely to reach another peak between next month and June, the Centers for Disease Control (CDC) said yesterday. Weekly hospital visits for the disease increased by 19 percent from the previous week, CDC Epidemic Intelligence Center Director Guo Hung-wei (郭宏偉) said. From Tuesday last week to yesterday, 21 cases of severe COVID-19 and seven deaths were confirmed, and from Sept. 1 last year to yesterday, there were 600 cases and 129 deaths, he said. From Oct. 1 last year to yesterday, 95.9 percent of the severe cases and 96.7 percent of the deaths
RSS