Abstract
Based on the findings from the Phase III clinical trials of inactivated SARS COV-2 Vaccine, (BBIBP-CORV) emergency use authorization (EUA) was granted for the vaccine to frontline workers in the UAE. A prospective cohort study was conducted among frontline workers to estimate the incidence rate and risk of symptomatic COVID-19 infection 14 days after the second dose of inoculation with BBIBP-CORV inactivated vaccine. Those who received two doses of the BBIBP-CORV vaccine in the period from 14th of September 2020 (first dose) to 21st of December 2020 (second dose) were followed up for COVID-19 infections. 11,322 individuals who received the two-dose BBIBP-CORV vaccine were included and were followed up post the second dose plus fourteen days. The incidence rate of symptomatic infection was 0.08 per 1000-person days (95% CI 0.07, 0.10). The estimated absolute risk of developing symptomatic infection was 0.97% (95% CI 0.77%, 1.17%). The confirmed seroconversion rate was 92.8%. There were no serious adverse events reported and no individuals suffered from severe disease. Our findings show that vaccinated individuals are likely to remain protected against symptomatic infection or becoming PCR positive for SARS COV 2 following the second dose of the vaccination.
Highlights
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 251 million people, with deaths exceeding 5 million worldwide, according to the World Health Organization report on November 20211
A prospective cohort study was conducted among frontline individuals at an increased risk of infection with SARS COV2, who received two doses of the BBIBP-CORV vaccine in the period between 14th of September 2020 to 21st of December 2020; and attended SEHA healthcare facilities in Abu Dhabi (UAE) for vaccination
The vaccine is recommended to be stored in original package in a refrigerator at + 2 to + 8 °C
Summary
The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 251 million people, with deaths exceeding 5 million worldwide, according to the World Health Organization report on November 20211. Preliminary findings of randomized, double-blinded, placebo-controlled phase 1 and 2 clinical trials to assess two different β-propiolactone-inactivated whole virus vaccines show that the BBIBP-CORV, vaccine was safe and well tolerated In these trials, individuals reported a low rate of vaccinerelated adverse reactions and demonstrated neutralizing antibody levels similar with those achieved with other vaccine candidates[3,4,5]. Individuals reported a low rate of vaccinerelated adverse reactions and demonstrated neutralizing antibody levels similar with those achieved with other vaccine candidates[3,4,5] Supported by these encouraging findings, and preliminary data from phase 3 trial, the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) granted an Emergency use authorization (EUA) for the inactivated SARS COV-2 Vaccine, BBIBP-CORV to frontline workers during September 2020 as an early attempt to protect individuals at high risk of infection[6]. The aim of this study is to estimate the incidence rate and risk of symptomatic and total COVID-19 infection 14 days after the second dose and to describe the antibody response (i.e. seroconversion) and the side effects experienced by the participants following vaccination
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