(220) BBIBP-Corv Vaccine: An Analysis of Adverse Events on Health Personnel by a Peruvian Pharmacovigilance Center

Publication Number: 1265

Background: In 2020, the World Health Organization (WHO) and the 42nd Global Advisory Committee on Vaccine Safety (GACVS) highlighted the importance to develop systems of surveillance of the safety of COVID-19 vaccine to identify and quantify adverse events following immunization (AEFI) and adverse events of special interest (AESI) in real-time, particularly in low-income and middle-income countries. BBIBP-CorV, an inactivated vaccine against COVID-19 developed by Sinopharm/China National Pharmaceutical Group, was firstly introduced in Peru. On February 2021, the immunization with BBIBP-CorV vaccine started among health personnel of the social security of health of Peru (EsSalud) and pharmacovigilance activities were implemented to better understand the safety profile of BBIVP-CorV in real-world context.

Objectives: To characterize adverse events following immunization (AEFI) with BBIVP-CorV and to identify/quantify adverse events of special interest (AESI) among health personnel of EsSalud between February 9 and August 21, 2021.

Methods: We developed a secondary analysis from the Pharmacovigilance database of EsSalud to calculate the AEFI reporting rate per 100, 000 doses of BBIBP-CorV vaccine. AEFI proportions by gender and age groups were compared. In addition, a multidisciplinary team of clinicians and epidemiologists assessed the potential AESI cases following the Brighton Collaboration case definition using electronic medical records. Finally, we performed a causality assessment or serious AEFI and AESI using the software elaborated by WHO.

Results: A total of 4376 AEFI were identified from 216 736 total doses of BBIBP-CorV administered to personnel of EsSalud, corresponding to the 2019 AEFI reporting rate per 100 000 doses. Systemic symptoms were the most notified, particularly nervous system disorders. AEFI occurred more frequently in women than males (2.33% vs 1.29%; p=0.025) in both doses. Regarding age, those between 40-65 years reported more N-AESI than those < 40 and >65 years (0.52% vs 0.47% vs 0.04%; p=0.001). Over 25 AEFI (1.2%) were classified as serious adverse events (SAE). After clinical evaluation, 23 met the AESI definition. According to the causality assessment, only the three cases of anaphylaxis were found to be associated with the BBIBP-CorV vaccine (A1), which were classified as severe, being the reporting rate of 1.4 cases per 100 000 doses.

Conclusions: BBIBP-CorV has an acceptable short-term safety profile, and thus might help decrease the hesitancy and conspiracy beliefs among the population. Our study presents a comprehensive clinical assessment of potential AESI and serious adverse events reports. Pharmacovigilance is elemental to ensure that the safety profile of vaccines against COVID-19 is acceptable.