Outcomes
deaths, clear chronic disease
ADVERSE EVENTS, ADVERSE EVENT, ASYMPTOMATIC SARS-COV-2 INFECTION, SECONDARY
The specific details regarding the safety and efficacy analyses were prespecified in the statistical analysis plan (version 2.0, dated Dec 6, 2022), which was finalised before data locking. The primary safety endpoints were solicited adverse events and reactions occurring within 7 days of either dose; adverse events and reactions occurring within 30 days of any dose; and serious adverse events, medically attended adverse events, and adverse events of special interest from the first dose (ie, day 0) to 12 months after the second dose.Adverse events were graded according to the China National Medical Products Administration (NMPA) guidelines (The primary efficacy endpoint was symptomatic SARS-CoV-2 infection confirmed by RT-PCR occurring 15 days or longer after the second dose. The secondary efficacy endpoints were virologically confirmed symptomatic SARS-CoV-2 infection of any severity in participants with or without a history of SARS-CoV-2 vaccination; in individuals of different age groups (18–59 years and ≥60 years); and in those with clear chronic disease; number of individuals with severe and critical COVID-19; and deaths from COVID-19. All secondary efficacy endpoints were assessed at 15 days or longer after the second vaccination.Due to the low number of individuals with COVID-19 we observed and ongoing virological-related studies, some of the prespecified exploratory endpoints (