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RESEARCH PRODUCT
Thrombotic complications of vaccination against SARS-CoV-2: what pharmacovigilance reports tell us – and what they don't
Stavros Konstantinidessubject
Venous ThrombosisPulmonary and Respiratory Medicine2019-20 coronavirus outbreakmedicine.medical_specialtyCoronavirus disease 2019 (COVID-19)SARS-CoV-2business.industrySevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)VaccinationCOVID-19ThrombosisVaccination03 medical and health sciencesEditorial0302 clinical medicine030228 respiratory systemPharmacovigilancemedicineHumans030212 general & internal medicineIntensive care medicinebusinessThrombotic complicationdescription
In the present issue of the Journal [1], Smadja et al. present an analysis of global pharmacovigilance reports of thrombotic events following severe acute respiratory distress syndrome coronavirus (SARS-CoV)-2 vaccination. More specifically, the authors analysed the data entered into the World Health Organization (WHO) Global Database for Individual Case Safety Reports (VigiBase) between December 13, 2020 and March 16, 2021, covering, at that time, a population of almost 362 million vaccinated individuals across the world. The study focuses on three of the coronavirus disease (COVID)-19 vaccines available to date, namely the Pfizer-BioNtech (BNT162b2), Moderna (mRNA-1273), and OxfordAstraZeneca (ChAdOx1 nCov-19) vaccine. The study by Smadja et al. confirms the rarity of possible thrombotic complications in association with COVID-19 vaccination, reporting only 0.21 [95% CI 0.19–0.22] cases of thrombotic events per million person vaccinated-days. However, there were also some unexpected observations which deserve closer attention and cautious interpretation.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-04-01 | European Respiratory Journal |