This is the key point. All other comments are about the base rates of general forms of thrombosis, but the concern is about a rare, special type. It is actually not inconceivable that the risk of death for young people from this vaccine might be higher than the risk from Covid-19.
Yes, that was the main argument for the decision of the PEI—the risk for a group that does not profit as much from a vaccine as older people.
If I had to guess:
The women had taken oral contraceptives.
Maybe this group will be excluded from this specific vaccine in the future.
(But it is just a guess, I am no expert).
Here additional background information from the German PEI (translation by deepl):
“In seven cases (as of 03/15/2021), a specific form of severe cerebral venous thrombosis associated with platelet deficiency (thrombocytopenia) and bleeding has been identified in temporal association with vaccination with AstraZeneca COVID-19 vaccine.
It is a very serious disease that is also difficult to treat. Of the seven affected individuals, three had died.
The affected individuals had ages ranging from about 20 to 50 years.
Six of the affected individuals had a particular form of cerebral venous thrombosis, namely 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 AstraZeneca COVID-19 vaccine. This presented as a comparable pattern.
The number of these cases after AstraZeneca COVID-19 vaccination 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 group of people affected by the severe cerebral venous thromboses with platelet deficiency is not the group of people at high risk for a severe or even fatal COVID-19 course.
In addition to the experts from the Paul Ehrlich Institute, other experts in thrombosis, hematology, and an adenovirus specialist were consulted with the details of the reported cases. All experts were unanimous in their opinion that a pattern could be discerned here and that a connection between the reported above-mentioned diseases and the AstraZeneca vaccination was not implausible.
After an overall review and consideration of the above facts, the Paul Ehrlich Institute recommended that vaccination with the AstraZeneca COVID-19 vaccine be suspended in Germany as a precautionary measure in order to further analyze 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 March 15, 2021, whether and how the new findings affect the benefit-risk profile of the AstraZeneca COVID-19 vaccine and the EU approval of the vaccine.”
This is the key point. All other comments are about the base rates of general forms of thrombosis, but the concern is about a rare, special type. It is actually not inconceivable that the risk of death for young people from this vaccine might be higher than the risk from Covid-19.
Yes, that was the main argument for the decision of the PEI—the risk for a group that does not profit as much from a vaccine as older people.
If I had to guess:
The women had taken oral contraceptives.
Maybe this group will be excluded from this specific vaccine in the future.
(But it is just a guess, I am no expert).
Here additional background information from the German PEI (translation by deepl):
“In seven cases (as of 03/15/2021), a specific form of severe cerebral venous thrombosis associated with platelet deficiency (thrombocytopenia) and bleeding has been identified in temporal association with vaccination with AstraZeneca COVID-19 vaccine.
It is a very serious disease that is also difficult to treat. Of the seven affected individuals, three had died.
The affected individuals had ages ranging from about 20 to 50 years.
Six of the affected individuals had a particular form of cerebral venous thrombosis, namely 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 AstraZeneca COVID-19 vaccine. This presented as a comparable pattern.
The number of these cases after AstraZeneca COVID-19 vaccination 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 group of people affected by the severe cerebral venous thromboses with platelet deficiency is not the group of people at high risk for a severe or even fatal COVID-19 course.
In addition to the experts from the Paul Ehrlich Institute, other experts in thrombosis, hematology, and an adenovirus specialist were consulted with the details of the reported cases. All experts were unanimous in their opinion that a pattern could be discerned here and that a connection between the reported above-mentioned diseases and the AstraZeneca vaccination was not implausible.
After an overall review and consideration of the above facts, the Paul Ehrlich Institute recommended that vaccination with the AstraZeneca COVID-19 vaccine be suspended in Germany as a precautionary measure in order to further analyze 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 March 15, 2021, whether and how the new findings affect the benefit-risk profile of the AstraZeneca COVID-19 vaccine and the EU approval of the vaccine.”
Source: PEI