translated from Spanish: The European Medicines Agency will today rule on the safety of the Janssen vaccine

The European Medicines Agency (EMA) plans to announce on Tuesday the findings of research into six cases of very rare thromboembolism detected in patients vaccinated with Janssen in the United States and will give its scientific verdict on whether the use of this vaccine remains safe and positive. At a press conference scheduled for 5 p.m. Dutch (15.00 GMT), executive director Emer Cooke and part of her team will explain from ema headquarters in Amsterdam the conclusions reached by the Security Committee (PRAC), which has been investigating for two weeks the risk of developing unusual blood clotting with Janssen.PraC, the committee responsible for assessing the safety problems of medicinal products for human use discusses the cases of six people who received Janssen and developed symptoms of venous brain thrombus (CVST) 6 to 13 days later, in combination with low blood platelet levels (thrombocytopenia). It only analyses the cases of six vaccinated patients in the United States, who have given 6.8 million people this vaccine from the Johnson & Johnson subsidiary. Several European countries have received their doses last week in the first installment of Janssen, but keep them stored pending the EMA verdict, on which the rate of vaccination in the European Union (EU) depends. The decision to postpone the use of Janssen in the EU came after last Tuesday, the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended discontinuing its use until these cases of a “rare and severe” type of blood clot are investigated and determining whether there is a causal relationship with the drug. Many European countries had their hopes set in Janssen because it is the first single-dose vaccine available in the community area. Pfizer/BioNTech, Moderna and AstraZeneca require two injections with an interval of several weeks apart, forcing half of the doses stored to complete the protection of those who received the first, while the rest of the country expects new deliveries. This is not the first time that the EMA has been seen in the scenario of deciding on the safety of an already authorised vaccine due to the detection of thromboembolism. Two weeks ago, he had to rule on the risk of developing blood clotting with AstraZeneca, and concluded that there was a “possible link” to those symptoms, but maintained that the benefits of the vaccine continue to outweigh its risks by helping against the pandemic and saving lives. The EMA will today put into perspective the percentage of thromboembolism with respect to the total population of vaccinated with Janssen, study the possible identification of a risk factor – such as age, sex or clinical history – and decide “whether regulatory action is necessary” in relation to the use of this vaccine in the EU, including adding blood clotting to the package leaflet as a possible unusual side effect. At the moment, the most common side effects of Janssen are usually “mild or moderate, and improve a day or two after” the injection, the EMA stresses.

Original source in Spanish