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Published on: August 4, 2023
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Thrombotic events and COVID-19 vaccines
Summary
Severe adverse events, including rare vaccine-induced prothrombotic immune thrombocytopenia linked to viral vector COVID-19 vaccines, were investigated. mRNA vaccines remain safe, with no increased thrombosis risk in those over 60.
Area of Science:
- Immunology
- Pharmacovigilance
- Epidemiology
Background:
- COVID-19 vaccines are crucial for pandemic control, but severe adverse events (AEs) have been reported post-authorization.
- Real-world data is essential to assess vaccine safety beyond clinical trials.
Purpose of the Study:
- To evaluate thromboembolic AEs following COVID-19 vaccination in real-world settings.
- To review the benefits and risks of EU-approved vaccines and provide recommendations.
- To understand the impact of safety signals on vaccination campaign continuity.
Main Methods:
- Literature review using Medline/PubMed.
- Analysis of institutional and pharmacovigilance reports.
- Assessment of safety data for viral vector and mRNA vaccines.
Main Results:
- Vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) identified as a rare AE with viral vector vaccines, primarily in women under 60.
- Vaccination campaigns for Vaxzevria and Janssen were paused due to safety concerns.
- No increase in deep vein thrombosis or pulmonary embolism reports; mRNA vaccines show continued safety.
- No increased thrombotic event rates observed in individuals over 60.
Conclusions:
- mRNA COVID-19 vaccines are safe and recommended for continued use.
- VIPIT risk factors require identification for informed decision-making.
- Ongoing systematic safety monitoring is vital to ensure vaccination benefits outweigh risks.
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