Reports of Batch-Dependent Suspected Adverse Events of the BNT162b2 mRNA COVID-19 Vaccine: Comparison of Results from Denmark and Sweden

被引:1
作者
Manniche, Vibeke [1 ]
Schmeling, Max [2 ]
Gilthorpe, Jonathan D. [3 ]
Hansen, Peter Riis [4 ,5 ]
机构
[1] LIVA, Rosenvaengets Alle 6A, DK-2100 Copenhagen, Denmark
[2] Innometric, Bavnehojvej 5, DK-9520 Hellum, Skorping, Denmark
[3] Umea Univ, Dept Med & Translat Biol, S-90187 Umea, Sweden
[4] Copenhagen Univ Hosp Herlev & Gentofte, Dept Cardiol, Gentofte Hospitalsvej 1, DK-2900 Hellerup, Denmark
[5] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Blegdamsvej 3B, DK-2200 Copenhagen, Denmark
来源
MEDICINA-LITHUANIA | 2024年 / 60卷 / 08期
关键词
COVID-19; BNT162b2; vaccine; safety; adverse events;
D O I
10.3390/medicina60081343
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background and Objective: An unexpected batch-dependent safety signal for the BNT162b2 mRNA COVID-19 vaccine was recently identified in a nationwide study from Denmark, but the generalizability of this finding is unknown. Therefore, we compared batch-dependent rates of suspected adverse events (SAEs) reported to national authorities in Denmark and Sweden. Materials and Methods: SAE and vaccine batch data were received from national authorities in Denmark and Sweden, and analyses of heterogeneity in the relationship between numbers of vaccine doses and SAEs per batch were performed, along with comparison of SAE rates and severities for batches that were shared between the two countries. Results: Significant batch-dependent heterogeneity was found in the number of SAEs per 1000 doses for both countries, with batches associated with high SAE rates detected in the early phase of the vaccination campaign and positive correlations observed between the two countries for the severity of SAEs from vaccine batches that they shared. Mild SAEs predominated in the batches used in the early part of the vaccination roll-out, where markedly higher SAE rates per 1000 doses in Denmark for the batches that were shared between the two countries suggested that a large proportion of these SAEs were under-reported in Sweden. Conclusions: The batch-dependent safety signal observed in Denmark and now confirmed in Sweden suggests that early commercial batches of BNT162b2 may have differed from those used later on, and these preliminary and hypothesis-generating results warrant further study.
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页数:9
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