Why the study?
The safety profile of inactivated poliomyelitis vaccine made from Sabin strains (sIPV) during its post-marketing real-world use in China from 2015 to 2025 needed evaluation.
Does the Sabin strain inactivated poliomyelitis vaccine (sIPV) improve safety outcomes (reduce adverse events) compared to national IPV benchmarks in infants receiving polio vaccination?
Observational (n=50,111,746)
Yes
Does the Sabin strain inactivated poliomyelitis vaccine (sIPV) improve safety outcomes (reduce adverse events) compared to national IPV benchmarks in infants receiving polio vaccination?
Absolute Event Rate: 25.52% vs 31.43%
p-value: p=<0.001
Real-world data over a decade confirms sIPV has an excellent safety profile, with lower overall and severe adverse event rates compared to national IPV benchmarks, robustly supporting its role in global polio eradication.
sIPV was associated with fewer AEFI than national IPV; extends observational safety data but should not yet change practice.
This study aimed to evaluate the safety profile of inactivated poliomyelitis vaccine made from Sabin strains (sIPV) developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences, during its post-marketing real-world use in China from 2015 to 2025. A database-based retrospective analysis was conducted using multi-source data, including the Chinese Center for Disease Control and Prevention's (CDC) Adverse Events Following Immunization (AEFI) surveillance system, post-marketing safety studies, and internal vaccination databases. Safety metrics were compared with national IPV (2018-2022) and all marketed vaccines. Statistical analyses employed chi-square and Fisher's exact tests. Among 50,111,746 sIPV doses administered, 12,788 AEFI cases were reported (25.52 per 100,000 doses). sIPV exhibited significantly lower AEFI reported incidences than national IPV data for pyrexia (≥38.6°C) (6.19 vs. 8.51 per 100,000 doses, P < .001), vaccination site erythema/swelling (>2.5 cm) (3.46 vs. 3.85 per 100,000 doses, P < .001), and vaccination site induration (>2.5 cm) (0.90 vs. 1.19 per 100,000 doses, P < .001). The incidence of severe AEFI (0.13 per 100,000 doses) was significantly different (P < .001) from that of the national IPV. Most AEFI (97.41%) occurred within 3 d post-vaccination, and 71.31% resolved completely. sIPV demonstrates an excellent safety profile, supporting its role in polio eradication. Continued monitoring is essential for rare events and regional disparities.
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Deng et al. (2026) conducted an observational in Healthy infants and children receiving polio vaccination (n=50,111,746). Sabin strain inactivated poliomyelitis vaccine (sIPV) vs. National IPV and all marketed vaccines was evaluated on Overall Adverse Events Following Immunization (AEFI) incidence per 100,000 doses (p=<0.001).
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