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Global and regional burden of vaccine-induced thrombotic thrombocytopenia, 1969-2023: Comprehensive findings with critical analysis of the international pharmacovigilance database

Lee, Sooji (författare)
Kyung Hee Univ, South Korea
Jo, Hyesu (författare)
Kyung Hee Univ, South Korea
Woo, Selin (författare)
Kyung Hee Univ, South Korea
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Jeong, Yi Deun (författare)
Kyung Hee Univ, South Korea
Lee, Hayeon (författare)
Kyung Hee Univ, South Korea
Lee, Kyeongmin (författare)
Kyung Hee Univ, South Korea
Lee, Jinseok (författare)
Kyung Hee Univ, South Korea
Kim, Hyeon Jin (författare)
Kyung Hee Univ, South Korea
Kang, Jiseung (författare)
Harvard Med Sch, MA USA; Massachusetts Gen Hosp, MA USA
Jacob, Louis (författare)
ISCIII, Spain; Univ Paris Cite, France
Smith, Lee (författare)
Anglia Ruskin Univ, England
Rahmati, Masoud (författare)
Aix Marseille Univ, France; Lorestan Univ, Iran; Vali E Asr Univ Rafsanjan, Iran
Sanchez, Guillermo F. Lopez (författare)
Univ Murcia, Spain
Dragioti, Elena (författare)
Linköpings universitet,Avdelningen för prevention, rehabilitering och nära vård,Medicinska fakulteten,Region Östergötland, Smärt och rehabiliteringscentrum,Univ Ioannina, Greece
Son, Yejun (författare)
Kyung Hee Univ, South Korea
Kim, Soeun (författare)
Kyung Hee Univ, South Korea
Yeo, Seung Geun (författare)
Kyung Hee Univ, South Korea
Park, Jaeyu (författare)
Kyung Hee Univ, South Korea
Yon, Dong Keon (författare)
Kyung Hee Univ, South Korea
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 (creator_code:org_t)
2024
2024
Engelska.
Ingår i: European Journal of Haematology. - : WILEY. - 0902-4441 .- 1600-0609.
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Objective: The scarcity of studies on vaccine-induced thrombosis and thrombocytopenia syndrome (TTS) limits the comprehensive understanding of vaccine safety on a global scale. Therefore, the objective of this study is to assess the global burden of vaccine-induced TTS, identify the vaccines most associated with it, and suggest clinical implications regarding vaccination. Methods: This study employed the World Health Organization international pharmacovigilance database, extracting records of vaccine-induced immune thrombotic thrombocytopenia from 1969 to 2023 (total reports, n > 130 million). Global reporting counts, reported odds ratios (ROR), and information components (IC) were calculated to identify the association between 19 vaccines and the occurrence of vaccine-induced TTS across 156 countries. Results: We identified 24 233 cases (male, n = 11 559 [47.7%]) of vaccine-induced TTS among 404 388 reports of all-cause TTS. There has been a significant increase in reports of vaccine-induced TTS events over time, with a noteworthy surge observed after 2020, attributed to cases of TTS associated with COVID-19 vaccines. Measles, mumps, and rubella (MMR) vaccines were associated with most TTS reports (ROR [95% confidence interval], 2.87 [2.75-3.00]; IC [IC0.25], 1.51 [1.43]), followed by hepatitis B (HBV, 2.23 [2.07-2.39]; 1.15 [1.03]), rotavirus diarrhea (1.95 [1.78-2.13]; 0.81 [0.53]), encephalitis (1.80 [1.50-2.16]; 0.84 [0.53]), hepatitis A (1.67 [1.50-1.86]; 0.73 [0.55]), adenovirus Type 5 vector-based (Ad5-vectored) COVID-19 (1.64 [1.59-1.68]; 0.69 [0.64]), pneumococcal (1.57 [1.49-1.66]; 0.65 [0.56]), and typhoid vaccines (1.41 [1.12-1.78]; 0.49 [0.11]). Concerning age and sex-specific risks, reports of vaccine-induced TTS were more associated with females and younger age groups. The age group between 12 and 17 years exhibited significant sex disproportion. Most of these adverse events had a short time to onset (days; mean [SD], 4.99 [40.30]) and the fatality rate was 2.20%, the highest rate observed in the age group over 65 years (3.79%) and lowest in the age group between 0 and 11 years (0.31%). Conclusion: A rise in vaccine-induced TTS reports, notably MMR, HBV, and rotavirus diarrhea vaccines, was particularly related to young females. Ad5-vectored COVID-19 vaccines showed comparable or lower association with TTS compared to other vaccines. Despite the rarity of these adverse events, vigilance is essential as rare complications can be fatal, especially in older groups. Further studies with validated reporting are imperative to improve the accuracy of assessing the vaccine-induced TTS for preventive interventions and early diagnosis.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Klinisk laboratoriemedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Clinical Laboratory Medicine (hsv//eng)

Nyckelord

global; thrombosis and thrombocytopenia syndrome; vaccine-induced immune thrombotic thrombocytopenia; vaccines; World Health Organization

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