Statistical analysis
EVENTS
In phase, I and phase II, vaccine safety and efficacy analysis for up to 1 year were performed on all vaccinated subjects (intention-to-treat). Vaccine safety is presented descriptively by showing the proportion of unintended events in each dose group. The efficacy of the vaccine for up to 1 year was presented descriptively by showing the proportion of COVID-19 incidence in each dose group. If you meet the requirements (the number of expected counts <5 does not exceed 20%), then the difference in proportion is tested using chi-square. However, if it does not meet the requirements, the proportion difference test is carried out using Fisher’s exact test.