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
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