The European Medicines Agency (EMA) is studying the risk of developing thromboembolism using Janssen’s preparations, while continuing to analyze three other Covid-19 vaccines, including Sputnik, which may be used in the European Union (EU) Divide by the risk of blood clots using AstraZeneca.
The Committee on Human Medicines (CHMP) has an open real-time analysis process for US vaccines Novax From February 3 last year; German CureVac Since February 12, Russia Sputnik 5 From March 4, but there is no set timetable, you can apply for conditional licenses for use in the EU, such as licenses granted to Pfizer/BioNtech, Moderna, AstraZeneca and Janssen.
EMA approved the use of Janssen on March 11 Subsidiary of Johnson & Johnson, The vaccine has not been used in the European Union (EU) due to delayed delivery of the dose by the laboratory.
The regulator confirmed on Friday that it is also investigating the vaccine, just like what has happened in AstraZeneca. After four severe blood clotting cases After inoculation of the preparation.
EMA analyzed the abnormally low platelet coagulation of these 4 patients who had previously received the vaccine. One of them was during clinical trials and three were during the use of Janssen in the United States. Among them, One who caused the death of the vaccinator.
“These reports point to safety signals, but it is not yet clear whether there are safety signals. Causality between vaccination Use Janssen vaccine and these conditions.
The first injection This single-dose vaccine The pharmaceutical company itself has announced that the product will arrive in European countries on April 19. Currently, it is only used in the United States.
Last Wednesday, EMA concluded an investigation, stating that “Possible connection” with AstraZeneca The vaccine was discovered within two weeks after the injection, so he decided to include this clinical picture among the very rare side effects of the vaccine authorized by the European Union.
However, although there are now several European countries that restrict its use nationwide to people over 60 years old, the EMA has not determined risk factors such as age, gender or specific clinical history. Explain the reported thromboembolism, And it is recommended to continue to use it, because its benefits outweigh the risks.
Regarding AstraZeneca, PRAC also reported today that it will review another “safety signal” related to the possible link to the vaccine, the so-called “safety signal”. “Capillary Leak Syndrome”, After EMA explained information on five cases of this very rare disease, the disease is characterized by “vascular leakage that causes tissue inflammation and lower blood pressure.”
These cases have been registered in the EudraVigilance database. The EudraVigilance database is a European network used to report adverse drug-related reactions, but the EMA emphasized that “it is not yet clear Causal connection Between the vaccination and the capillary leak report”, or this is a coincidence of time.
So far, although Novavax and Curevac have not been shocked, the Sputnik V vaccine is full of controversy. EMA will execute “Examination of Good Clinical Practice” How to test volunteers in Russia to determine whether the correct scientific and ethical procedures have been followed.
Moscow stated that military and state employees participated in a vaccine trial developed by the State Direct Laboratory and funded by the Russian Direct Investment Fund (RDIF). The sovereign fund of the Kremlin, They pointed out that there was no pressure on those who participated in the trial.
According to the digital newspaper EU observer, 4 people died in Russia (died from problems related to the heart, lungs or blood sugar), and 6 others developed medical complications in Russia A few days after receiving Sputnik V, Although it is not clear that these cases are directly related to vaccination.
Although it has not yet been recognized by European scientists and has not signed a centralized purchase contract with Brussels, Berlin and the Russian Direct Investment Fund (FIDR), it has opened bilateral negotiations for the agreement. Germany will buy a certain dose of artificial satellite V in the future, When it was approved from EMA.