Controversy over domestic drugmaker Medigen’s COVID-19 vaccine could have been avoided had the company published data on its phase 2 clinical trials in international journals, National Taiwan University (NTU) College of Public Health vice dean Tony Chen (陳秀熙) said yesterday.
The government on Sunday granted emergency use authorization (EUA) to the Medigen jab after an expert panel said that antibody levels in the blood of phase 2 trial participants met local standards.
However, critics said that the experts’ reasoning was not convincing because not all trial data had been publicized and that Taiwan is the only country to conditionally approve a vaccine that has not yet passed phase 3 clinical trials.
Medigen on Tuesday said it had received approval to conduct phase 3 trials on 1,000 people in Paraguay.
Chen yesterday said that the Paraguay trials’ methodology and safety precautions would be well within international standards, but whether the vaccine could provide sufficient protection, especially against highly infectious variants of SARS-CoV-2, could only be determined with additional trials.
Chen said that he believes the expert panels’ assessment on which the EUA is based, but that the company lacks sufficient credibility based on publication in scientific journals.
“Trial data of the COVID-19 vaccines that are in use worldwide — AstraZeneca, Pfizer-BioNTech, Moderna, Johnsons & Johnson and Novavax, among others — have been published in credible international journals,” Chen said, adding that this, not the transparency of the approval process in various countries, gives them credibility.
Even China last year publicized the phase 2 trial results of the Sinovac COVID-19 vaccine, he said.
The publication of trial data is a critical step that the Medigen vaccine must take, Chen said, adding that verification by the international medical community would be crucial to calm the worries of Taiwanese.
Taoyuan Mayor Cheng Wen-tsan (鄭文燦) and Tainan Mayor Huang Wei-che (黃偉哲), both of the Democratic Progressive Party, have said that they would be willing to receive the Medigen vaccine as their second shot, while New Taipei City Mayor Hou You-yi (侯友宜) of the Chinese Nationalist Party (KMT) has said that the jab’s efficacy should first be determined by the scientific community, not by politics.
Transparency is key to winning public support, Hou said, adding that public support is key to whether the Medigen jab would become widely accepted.
Additional reporting by Lai Hsiao-tung
The brilliant blue waters, thick foliage and bucolic atmosphere on this seemingly idyllic archipelago deep in the Pacific Ocean belie the key role it now plays in a titanic geopolitical struggle. Palau is again on the front line as China, and the US and its allies prepare their forces in an intensifying contest for control over the Asia-Pacific region. The democratic nation of just 17,000 people hosts US-controlled airstrips and soon-to-be-completed radar installations that the US military describes as “critical” to monitoring vast swathes of water and airspace. It is also a key piece of the second island chain, a string of
A magnitude 5.9 earthquake that struck about 33km off the coast of Hualien City was the "main shock" in a series of quakes in the area, with aftershocks expected over the next three days, the Central Weather Administration (CWA) said yesterday. Prior to the magnitude 5.9 quake shaking most of Taiwan at 6:53pm yesterday, six other earthquakes stronger than a magnitude of 4, starting with a magnitude 5.5 quake at 6:09pm, occurred in the area. CWA Seismological Center Director Wu Chien-fu (吳健富) confirmed that the quakes were all part of the same series and that the magnitude 5.5 temblor was
Taiwan will now have four additional national holidays after the Legislative Yuan passed an amendment today, which also made Labor Day a national holiday for all sectors. The Chinese Nationalist Party (KMT) and Taiwan People’s Party (TPP) used their majority in the Legislative Yuan to pass the amendment to the Act on Implementing Memorial Days and State Holidays (紀念日及節日實施辦法), which the parties jointly proposed, in its third and final reading today. The legislature passed the bill to amend the act, which is currently enforced administratively, raising it to the legal level. The new legislation recognizes Confucius’ birthday on Sept. 28, the
The Central Weather Administration has issued a heat alert for southeastern Taiwan, warning of temperatures as high as 36°C today, while alerting some coastal areas of strong winds later in the day. Kaohsiung’s Neimen District (內門) and Pingtung County’s Neipu Township (內埔) are under an orange heat alert, which warns of temperatures as high as 36°C for three consecutive days, the CWA said, citing southwest winds. The heat would also extend to Tainan’s Nansi (楠西) and Yujing (玉井) districts, as well as Pingtung’s Gaoshu (高樹), Yanpu (鹽埔) and Majia (瑪家) townships, it said, forecasting highs of up to 36°C in those areas
RSS