The European drug regulatory agency recommends recording “these rare blood clot cases” together with thrombocytopenia as “very rare side effects”, but insists that the risks and benefits of vaccination are beneficial. His goal now is to complete the scientific evidence for this link and determine the possible risk group.
European Medicines Agency (EMAIt was concluded that cerebral venous thrombosis, visceral venous thrombosis, and platelet decline were found in patients receiving the Oxford/AstraZeneca vaccine Should be considered a “very rare side effect” This serum.
To reach this conclusion, the EMA Pharmacovigilance Committee (wash) Analyzed 62 cases of cerebral venous sinus thrombosis and 24 cases of visceral venous thrombosis reported to the European Union Drug Safety Database, EudraVigilance, Of which 18 people died.
As they pointed out, these rare cases of thrombocytopenia (low platelets) may be caused by the vaccine “triggered” the immune response, which is an atypical disease. Heparin-induced thrombocytopenia. However, PRAC insists on not knowing whether this is the ultimate cause, and has not yet determined specific risk factors.
It is important that both vaccinated individuals and healthcare professionals must be aware of the signs and symptoms of these abnormal bleeding disorders and be able to quickly test them to minimize the risk.
Therefore, the agency has reminded health authorities and people who have been vaccinated that they “should be aware” of the possibility of a very small number of blood clots and low platelet levels within two weeks after vaccination. For reference, as of April 4, 169 cases of cerebral venous thrombosis and 53 cases of visceral venous thrombosis were reported among 34 million people in the United Kingdom and the European Union.
EMA executive director Emer Cooke said, “It is important that both vaccinated persons and health professionals must be aware of the signs and symptoms of these abnormal bleeding disorders and be able to detect them quickly to minimize the risk.”
Cook said: “EMA will continue to monitor all available scientific evidence on the effectiveness and safety of all licensed covid-19 vaccines, and make new recommendations based on strong evidence when necessary.”
He added: “This case shows that our pharmacovigilance system is effective: these very rare and unusual events are collected, identified, and analyzed, and we have made clear scientifically-based recommendations to allow safe and effective use of vaccines.”
Comprehensive review of registered cases
The EMA’s Pharmacovigilance Committee, with the help of a team of experts, conducted a comprehensive review of rare and unusual cases of blood clots with low platelets. To this Who checked the details.
To date, most reported cases have occurred in women under 60 years of age within two weeks of immunization. “Based on the currently available evidence, no specific risk factors can be determined. Therefore, it is not recommended to take any specific measures to reduce the risk,” continued PRAC President Sabine Straus.
“Although most cases occurred in people under 60 and women, the committee did not conclude that age and gender are obvious risk factors for these uncommon diseases due to the different ways in which vaccines are used in different countries. Effect,” he Say.
Straus pledged to conduct more research and analysis in this regard: “While continuing the vaccination campaign, PRAC will continue to evaluate all evidence on this issue.”