Safety signal (risk of thrombosis in combination with thrombocytopenia) VAXZEVRIA/COVID-19 Vaccine
Safety signal (risk of thrombosis in combination with thrombocytopenia) VAXZEVRIA/COVID-19 Vaccine
Safety signal (risk of thrombosis in combination with thrombocytopenia) VAXZEVRIA/COVID-19 Vaccine
European Medicines Agency EMA) has published Direct healthcare professional communications (DHPC) regarding VAXZEVRIA/COVID-19 Vaccine link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Key facts of DHPC
| Medicine name | VAXZEVRIA/COVID-19 Vaccine AstraZeneca suspension for injection |
| Active substance | (ChAdOx1-S [recombinant]) |
| Therapeutic area (MeSH) | COVID-19 virus infection |
| DHPC type | Safety signal |
| Date Dissemination | 13 Apr 2021 |
Safety signal (risk of thrombosis in combination with thrombocytopenia) VAXZEVRIA/COVID-19 Vaccine
Summary
- A causal relationship between the vaccination with Vaxzevria and the occurrence of thrombosis in combination with thrombocytopenia is considered plausible.
- Although such adverse reactions are very rare, they exceeded what would be expected in the general population.
- No specific risk factors have been identified at this stage.
- Healthcare professionals should be alert to the signs and symptoms of thromboembolism and or thrombocytopenia and inform vaccines accordingly.
- The use of this vaccine should be in accordance with official national recommendations.
DHPC Communication
| Medicinal product(s)/active substance(s) | VAXZEVRIA/COVID-19 Vaccine AstraZeneca suspension for injection |
| Safety concern and purpose of the communication | Updated information on the risk of thrombosis in combination with thrombocytopenia |
| DHPC recipients | General practitioners, specialists in internal medicine, haematology, emergency medicine and vaccination centres.
The target group should be further defined at national level, in agreement with the respective national competent authority |
| Member States where the DHPC will be distributed | All EU member states where COVID-19 Vaccine AstraZeneca is marketed |
Source from EMA site
Call for reporting
Healthcare professionals should report any suspected adverse reactions associated with the use of Vaxzevria in accordance with the national spontaneous reporting system.
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