By NewsDesk @bactiman63
The Spanish Agency for Medicines and Health Products (AEMPS) has reported over the last week several cases of thrombotic events in some European countries, including Spain, temporarily related to the administration of the vaccine against COVID -19 from AstraZeneca.
The initial assessment of these reported cases of thrombotic events did not show a disproportion between the number of reported cases among vaccinated individuals and the number of naturally occurring cases in the general population. The fact that the reported cases were not related to a single lot also indicated that there was no quality defect related to a specific lot. In this context, the AEMPS reported, pending additional data and in line with what was reported by the EMA, that there were no reasons to justify the adoption of precautionary measures either on a specific batch or on the vaccine as a whole.
However, throughout this past Saturday and Sunday (March 13 and 14), and today, some notifications have been received (one of them in Spain) of a specific type of thrombotic event that needs to be studied further. thoroughly as they are very rare in the general population1. These are cases of cerebral venous thrombosis (specifically, cerebral venous sinus thrombosis), with the particularity of being associated with a decrease in the number of platelets in the blood, which would suggest an abnormal activation of the coagulation system that would result in this obstruction of the cerebral veins.
The AEMPS and the rest of the drug agencies coordinated by the EMA, work to collect and analyze the information available on this signal as quickly as possible. It is estimated that more than 17 million people have received the AstraZeneca vaccine in the UK and the European Union and the number of reported cases is very low in proportion to the number of people vaccinated. In the EU, approximately six million doses of this vaccine have been administered and the AEMPS has learned of at least 11 cases of cerebral venous sinus thrombosis reported in the EU, two of them reported today.
However, this subgroup of cases should be studied to know if in addition to having a temporal relationship with the administration of the vaccine, there is a possible causal relationship. The evaluation of this type of signs may end up finding an alternative cause to the administration of the vaccine or, if it is attributable to the vaccine, with measures that try to minimize the risk as much as possible, such as, for example, the identification of factors that predispose to the appearance of this type of thrombosis.
Given that it has not been possible to find a link with a certain batch of the vaccine, and while investigating whether these events, which the AEMPS and the rest of the European agencies have heard about this weekend, are related or not to the vaccine, the Ministry of Health considers it prudent to suspend vaccination with the AstraZeneca vaccine against COVID-19 from tomorrow and for the next two weeks.