The preventive effect of the US pharmaceutical company Modena's COVID-19 vaccine was recognized at the first expert advisory meeting of the Ministry of Food and Drug Safety.
The Ministry of Food and Drug Safety announced the results of clinical trials of Modena vaccines by the Advisory Group for verifying the safety and effectiveness of the COVID-19 vaccine.
The validation advisory group evaluated the safety and effectiveness of the clinical trial results in which approximately 30,000 people were administered the vaccine and the reference drug in the United States.
First, as a result of examining the effectiveness of 28,207 people (14,134 in the vaccine group, 14,73 in the control group) who completed the second dose of the vaccine, the preventive effect was confirmed to be about 94.1%. That’s it.
It showed more than 86% of preventive effects regardless of age or underlying disease.
In the vaccine-treated group, there were no cases of severe patients or deaths from COVID-19.
About 1.0% of serious adverse events were reported in both the vaccine group and the control group, and serious adverse drug reactions that could not be excluded from the vaccine administration were facial midsoles, but most were recovering at the time of submission of clinical trial data.
Accordingly, the verification advisory group considered that the abnormal cases that occurred in the clinical trial were acceptable.