A specific form of severe cerebral venous thrombosis associated with platelet deficiency (thrombocytopenia) and bleeding has been identified in seven cases (as of 15 March 2021) in temporal association with vaccination with COVID-19 Vaccine AstraZeneca.
- It is a very serious disease that is also difficult to treat. Of the seven affected individuals, three individuals had died.
- The affected individuals had ages ranging from about 20 to 50 years.
- Six of the affected persons had a particular form of cerebral venous thrombosis, called sinus vein thrombosis. All six individuals were younger to middle-aged women (see above). Another case with cerebral hemorrhage in platelet deficiency and thrombosis was medically very comparable. All cases occurred between four and 16 days after vaccination with COVID-19 Vaccine AstraZeneca. This presented as a comparable pattern.
- The number of these cases after vaccination with COVID-19 AstraZeneca is statistically significantly higher than the number of cerebral venous thromboses that normally occur in the unvaccinated population. For this purpose, an observed-versus-expected analysis was performed, comparing the number of cases expected without vaccination in a 14-day time window with the number of cases reported after approximately 1.6 million AstraZeneca vaccinations in Germany. About one case would have been expected, and seven cases had been reported.
- The younger to middle-aged population affected by the severe cerebral venous thrombosis with platelet deficiency is not the population at high risk for a severe or even fatal COVID-19 course.
- In addition to the experts from the Paul-Ehrlich-Institut, other experts in thrombosis, haematology, and an adenovirus specialist were consulted with the details of the reported cases. All experts agreed unanimously that a pattern could be discerned here and that a connection between the reported above-mentioned diseases and the vaccination with COVID-19 Vaccine AstraZeneca was not implausible.
After an overall review and consideration of the above facts, the Paul-Ehrlich-Institut recommended that vaccination with the COVID-19 Vaccine AstraZeneca be suspended in Germany as a precautionary measure in order to further analyse the cases. The German Federal Ministry of Health (BMG) has followed this recommendation. The Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA) will review during the week of 15 March 2021, whether and how the new findings affect the benefit-risk profile of COVID-19 AstraZeneca and the EU authorisation of the vaccine.