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.
RULES TIGHTENED: Passengers arriving from Sydney and Los Angeles tested positive for COVID-19, while passengers arriving from Seattle all tested negative Seventeen of the 217 passengers who arrived on long-haul at Taiwan Taoyuan International Airport yesterday morning tested positive for COVID-19, the Central Epidemic Command Center (CECC) said, adding that the positivity rate was higher than expected. Yesterday was the first day that the government enforced stricter health guidelines for the testing of passengers arriving on long-haul flights. They must undergo a polymerase chain reaction test immediately after arriving at the nation’s international airports. Those who test positive are sent directly to hospitals to avoid spreading the virus to people working in and around the airports and at quarantine hotels. Victor Wang (王必勝),
‘NEW YEAR GIFT’: While the MAC called the song propaganda, China’s Taiwan Affairs Office said that it addressed the homesickness of ‘Taiwanese compatriots’ A pro-unification pop song aired on Chinese television earlier this month would only further sour Taiwanese sentiment toward China, the Mainland Affairs Council (MAC) said on Wednesday. The music video for We Sing the Same Song (我們同唱一首歌), which aired on China Central Television, features Chinese artists performing alongside Taiwanese singers Jam Hsiao (蕭敬騰), Ouyang Nana (歐陽娜娜) and Chen Li-nong (陳立農). The lyrics were reportedly written by Taiwanese lyricist Vincent Fang (方文山), known for his collaborations with Jay Chou (周杰倫), to music composed by a Chinese musician. Sung in Chinese and Hoklo (commonly known as Taiwanese), the song is about three Taiwanese siblings who
President Tsai Ing-wen’s (蔡英文) administration is seeking to join an Indo-Pacific economic framework being planned by the US, a senior official said. The government is paying close attention to the regional economic pact being touted by US President Joe Biden, although too few details have emerged from Washington for Taipei to make specific plans, the official said, speaking on the condition of anonymity. The US is expected to launch the Indo-Pacific economic framework next month after negotiations with Australia, India and Japan, the official said. The economic initiative is to tackle trade facilitation, standards for the digital economy and technology, supply-chain resiliency and
‘CHAOS’: Victor Wang, the CECC’s on-site commander at Taiwan Taoyuan International Airport, said testing of arrivals has sped up in time to meet holiday demand For now, people are not banned from eating and drinking on trains, despite the rise in locally transmitted cases of COVID-19, Minister of Transportation and Communications Wang Kwo-tsai (王國材) told reporters on the sidelines of a meeting of the legislature’s Transportation Committee yesterday. “On Sunday, the Central Epidemic Command Center (CECC) announced that the nation would remain on a level 2 COVID-19 alert until at least Jan. 24. So we will follow the center’s disease prevention guidelines for passengers on public transport systems,” Wang said. However, bus and train depots have been asked to disinfect facilities more frequently, he said. The center’s new