Thread by @udogumpel

@f_ronchetti Non sono d'accordo. Per quanto ne sappia, non è stata la Merkel a sospendere, ma l"Aifa" tedesca, Paul-Ehrlich-Institut": "Compared to the status on 11 March 2021, additional cases (as of Monday, 15 March 2021) have now been reported in Germany. 1/n pei.de/EN/newsroom/hp…

@f_ronchetti Analysing the new data status, the experts of the PEI now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a deficiency of blood platelets (thrombocytopenia) 2/n

@f_ronchetti ...and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine #AstraZeneca .

@f_ronchetti 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. 3/n

@f_ronchetti It is a very serious disease that is also difficult to treat. Of the seven affected individuals, three individuals had died.(2) The affected individuals had ages ranging from about 20 to 50 years.(3) Six of the affected persons had a particular form of cerebral venous thrombosis

@f_ronchetti called sinus vein thrombosis. All six individuals were younger to middle-aged women. 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 AZ

@f_ronchetti This presented as a comparable pattern.(4) The number of these cases after vaccination with COVID-19 AstraZeneca is statistically significantly higher than the number of cerebralvenous thromboses that normally occur in the unvaccinated population.

@f_ronchetti 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.

@f_ronchetti About one case would have been expected, and seven cases had been reported.(5) 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.

@f_ronchetti 6) 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

@f_ronchetti 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

@f_ronchetti be suspended in Germany as a precautionary measure in
Pagee 2/4order to further analyse the cases. The German Federal Ministry of Health (BMG) has followed this recommendation.

@f_ronchetti 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.