Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (1): 29-36.
DOI: 10.19803/j.1672-8629.20240968

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Safety Surveillance for Vaccine-Induced Immune Thrombotic Thrombocytopenia: a Systematic Review

SUN Yixin1,2, WANG Chen3, YU Yuelin4, GUO Peng1,2,5#, NIE Xiaolu6,*   

  1. 1Clinical Research Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    2Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    3Outpatient Department, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    4Department of Scientific Research, Huashan Hospital, Fudan University, Shanghai 200040, China;
    5Key Laboratory of Major Diseases in Children,Ministry of Education, Beijing 100045, China;
    6Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China
  • Received:2024-12-09 Online:2025-01-15 Published:2025-01-22

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Abstract: Objective To review the safety surveillance of vaccine-induced immune thrombotic thrombocytopenia (VITT). Methods The evidence-based medicine method was used in this research. PubMed (including Medline), Embase, Cochrane Library, CNKI, Wanfang, VIP and SinoMed were searched for eligible studies on the safety surveillance for VITT published between the inception of each database and September 30, 2024. Two researchers independently screened the literature and retrieved data. Qualitative methods of systematic review were used to summarize information from the literature, and the incidence rates (including reporting rates) and risks of VITT were analyzed. Results A total of 24 articles were included, which could be divided into two categories: 15 passive surveillance studies based on spontaneous reporting systems, and 9 active surveillance studies based on population or electronic healthcare databases. The results showed that VITT mostly occurred after the COVID-19 adenovirus-vectored vaccination (especially the first dose). The reporting rates ranged from 0.2/million doses to 19.9/million doses, and the incidence rates ranged from 2.11/100 000 person-years to 311/100 000 person-years. There were fewer reports on other types of COVID-19 vaccines, but some studies found that mRNA vaccines might also lead to an increased risk of VITT. Additionally, eight vaccines, including the measles-mumps-rubella vaccine, hepatitis B vaccine, rotavirus vaccine, encephalitis vaccine and hepatitis A vaccine, were also observed to be associated with VITT. In the included literature, nine studies reported the diagnostic criteria for VITT, involving five primary factors: recent vaccination history, thrombosis, concurrent thrombocytopenia, specific laboratory findings, and a comprehensive assessment by clinical experts. Conclusion VITT is a potential adverse event following immunization that requires extensive attention and can occur after multiple vaccine types. Its pathogenesis, clinical manifestations, and laboratory test characteristics have not yet been clarified and need to be understood and explored in depth by further studies.

Key words: Vaccine, Adverse Event Following Immunization, Vaccine-Induced Immune Thrombotic Thrombocytopenia, Thrombosis with Thrombocytopenia Syndrome, Safety Surveillance

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