Understanding thrombosis with thrombocytopenia syndrome after COVID-19 vaccination

被引:32
作者
Buoninfante, Alessandra [1 ]
Andeweg, Arno [1 ]
Baker, Alexander T. [2 ,3 ]
Borad, Mitesh [4 ]
Crawford, Nigel [5 ]
Dogne, Jean-Michel [6 ]
Garcia-Azorin, David [7 ]
Greinacher, Andreas [8 ]
Helfand, Rita [9 ,10 ]
Hviid, Anders [11 ,12 ]
Kochanek, Stefan [13 ]
Lopez-Fauqued, Marta [14 ]
Nazy, Ishac [15 ]
Padmanabhan, Anand [16 ]
Pavord, Sue [17 ]
Prieto-Alhambra, Daniel [18 ,19 ]
Tran, Huyen [20 ,21 ]
Wandel Liminga, Ulla [22 ]
Cavaleri, Marco [1 ]
机构
[1] European Med Agcy, Hlth Threats & Vaccines Strategy, Amsterdam, Netherlands
[2] Mayo Clin, Div Hematol & Med Oncol, Scottsdale, AZ 85054 USA
[3] Cardiff Univ, Sch Med, Div Canc & Genet, Cardiff CF14 4XN, Wales
[4] Mayo Clin, Ctr Canc, Phoenix, AZ 85054 USA
[5] Univ Melbourne, Royal Childrens Hosp, Murdoch Childrens Res Inst, Dept Paediat, Melbourne, Vic, Australia
[6] Univ Namur, Namur Res Inst Life Sci, Dept Pharm, Namur, Belgium
[7] Hosp Clin Univ Valladolid, Dept Neurol, Valladolid, Spain
[8] Univ Med Greifswald, Dept Transfus Med, Greifswald, Germany
[9] CDC, Natl Ctr Emerging & Zoonot Infect Dis, Atlanta, GA 30333 USA
[10] WHO, WHOs Global Advisory Comm Vaccine Safety, Geneva, Switzerland
[11] Univ Copenhagen, Fac Hlth & Med Sci, Dept Drug Dev & Clin Pharmacol, Pharmacovigilance Res Ctr, Copenhagen, Denmark
[12] Statens Serum Inst, Dept Epidmiol Res, Copenhagen, Denmark
[13] Univ Ulm, Dept Gene Therapy, Ulm, Germany
[14] European Med Agcy, Vaccines & Therapies Infect Dis, Amsterdam, Netherlands
[15] McMaster Univ, McMaster Ctr Transfus Res, Hamilton, ON, Canada
[16] Mayo Clin, Dept Lab Med & Pathol, Rochester, MN USA
[17] Oxford Univ Hosp NHS Fdn Trust, Dept Hematol, Oxford, Oxon, England
[18] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Ctr Stat Med CSM, Oxford, England
[19] Erasmus Univ, Dept Med Informat, Med Ctr, Rotterdam, Netherlands
[20] Alfred Hosp, Dept Clin Haematol, Melbourne, Vic, Australia
[21] Monash Univ, Australian Ctr Blood Dis, Cent Clin Sch, Melbourne, Vic, Australia
[22] Med Prod Agcy, Uppsala, Sweden
关键词
CHADOX1; NCOV-19; ANTIBODIES;
D O I
10.1038/s41541-022-00569-8
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Safety and efficacy of vaccines against the SARS-CoV-2 coronavirus has been demonstrated in clinical trials and next by their real world use through the course of the ongoing COVID-19 pandemic. However, very rare adverse events have been detected post-authorization in certain parts of the world. This meeting report summarizes an EMA workshop's discussion on the epidemiology, clinical presentation and biology of thrombosis with thrombocytopenia syndrome after adenovirus vector COVID-19 vaccination. General agreement was reached by international regulators, scientists and developers on the steps needed to fill the gaps in the characterization of this new syndrome. In particular, actions should be taken to improve the post-vaccination surveillance activities in low and middle income countries and investigate potential genetic predisposition factors.
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页数:6
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