Vaccine · 2026
Post-marketing safety surveillance of the BBIBP-CorV (Sinopharm) COVID-19 vaccine in Peruvian healthcare workers: A retrospective analysis of a Pharmacovigilance Center.
СтатьяНазвание и аннотация: Перевод в очереди
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Yesenia Rodríguez-Tanta L, Delgado-Escalante Raquel, Del Pilar Solis-Yucra Tania, Rojas Enrique Cachay, Lozada Guisela Alva, Veramendi-Espinoza Liz E, Espinoza-Ildefonso Vladimir, Saromo-Meléndez Violeta, Lazarte-Ramos Anaís, Aldave Juan Carlos, Pimentel Mariela Milla, Torres Carla Garcia, Valdiviezo Claudia Rentería, Lechuga-Noa Víctor E
Аннотация
INTRODUCTION: The inactivated SARS-CoV-2 vaccine (BBIBP-CorV) was first introduced in Peru among healthcare workers. We evaluated its safety profile by analyzing adverse events following immunization (AEFI) reports and conducting clinical and causality assessments for cases meeting criteria for adverse events of special interest (AESI) and serious adverse events (SAEs).
METHODS: We conducted a retrospective analysis using data from the Pharmacovigilance Center of EsSalud. We identified, estimated the overall reporting rate, and described key characteristics of AEFI reports, including differences by gender and age group. Clinicians trained in vaccine safety performed clinical assessments for AESIs and SAEs based on medical records and conducted formal causality assessments.
RESULTS: From February to August 2021, we identified 2280 AEFI reports (1052 per 100,000 doses; 95% CI 1009-1097), corresponding to 4376 adverse event terms. Of these, 22 met AESI criteria, with only two anaphylaxis cases causally linked to the vaccine (A1). The remaining 4354 events were grouped into 14 MedDRA SOC categories, with nervous system disorders (30%) and injection site reactions (11%) most frequent. Gastrointestinal events were more common in women (12.6% vs. 7.9%, p < 0.001), while men reported more general disorders (16% vs. 10.9%, p < 0.001). Adults ≥65 years reported more vascular and eye disorders. Fifteen events were categorized as SAEs and classified as category C.
CONCLUSIONS: This first post-marketing safety evaluation of BBIBP-CorV among Peruvian healthcare personnel found a low AEFI reporting rate, with mostly mild events. Access to medical records enabled accurate assessment, supporting local pharmacovigilance and public health decision-making.
METHODS: We conducted a retrospective analysis using data from the Pharmacovigilance Center of EsSalud. We identified, estimated the overall reporting rate, and described key characteristics of AEFI reports, including differences by gender and age group. Clinicians trained in vaccine safety performed clinical assessments for AESIs and SAEs based on medical records and conducted formal causality assessments.
RESULTS: From February to August 2021, we identified 2280 AEFI reports (1052 per 100,000 doses; 95% CI 1009-1097), corresponding to 4376 adverse event terms. Of these, 22 met AESI criteria, with only two anaphylaxis cases causally linked to the vaccine (A1). The remaining 4354 events were grouped into 14 MedDRA SOC categories, with nervous system disorders (30%) and injection site reactions (11%) most frequent. Gastrointestinal events were more common in women (12.6% vs. 7.9%, p < 0.001), while men reported more general disorders (16% vs. 10.9%, p < 0.001). Adults ≥65 years reported more vascular and eye disorders. Fifteen events were categorized as SAEs and classified as category C.
CONCLUSIONS: This first post-marketing safety evaluation of BBIBP-CorV among Peruvian healthcare personnel found a low AEFI reporting rate, with mostly mild events. Access to medical records enabled accurate assessment, supporting local pharmacovigilance and public health decision-making.