High-end vaccines (6547-TW) Today (30th) held a shareholders meeting, general manager Chen Canjian said that its new crown vaccine MVC-COV1901 participated in the World Health Organization (WHO) Global Solidarity Phase III clinical trial, and has reached the mid-term analysis conditions, but WHO updated the vaccine listing standards, data analysis The difficulty has increased and the overall time course has been extended, and WHO has mentioned that the trial data will be released at any time.
The new crown vaccine STV Solidarity Trial Vaccines conducted by WHO is mainly aimed at stabilizing the global vaccine supply. Chen Canjian said that WHO has screened 5 vaccines around the world. Among them, high-end clinical trials have been completed and 18,000 cases have been received. It has reached the conditions for unblinding the mid-term analysis, and is analyzing the safety and efficacy of the vaccine.
With the change of the epidemic situation, WHO revised the vaccine marketing standard (TPP). The old version is that the vaccine effectiveness (VE) must reach 50%, which is the market standard. In addition to using VE 50% as a reference index, the new version also uses the vaccine as a reference index. The critical protection ability is included in the evaluation, as well as supplementary agents and mixed beatings.
Chen Canjian admitted that following the WHO changed the vaccine listing standards, it has also become a difficult point in the analysis of clinical trial data, including whether patients are hospitalized, severe, etc. In addition, the WHO also relies on other independent units to obtain information, resulting in a relatively long process. WHO said that at any time There will be answers, but the timing is uncertain.
Regarding the blinding time of the trial, Chen Canjian said that in the past, the high-end second-phase blinding solution implemented in Taiwan will soon publish the data, but for the sake of fairness and scientificity, the WHO sends all scientific data to many units, and they belong to large universities. For large-scale, cross-state and cross-field clinical trials, statistical analysis requires time for a complete report.
Chen Canjian pointed out that in fact, it took a long time for WHO to carry out Ebola vaccine clinical trials in the past. Although the clinical unblinding time of new crown vaccine is still dominated by WHO, WHO has mentioned that high-end is carried out under the epidemic situation of many mutant strains. The clinical trials of omicron showed that if the unblinding is successful, it can be proved that its vaccine can prevent omicron.
