The European Medicines Agency confirmed that the balance between the benefits and risks of the Janssen vaccine is still “positive”
This European Medicines Agency (EMA) found on Tuesday that there is a “possible link” between the formation of a very rare blood clot and the covid-19 vaccine developed by Janssen Pharmaceuticals, but confirmed that the benefits and risks of the preparation are still in balance “positive”.
After a two-week investigation, eight cases of very rare thromboembolism were found in patients who received the hepatitis B vaccine. Janssen of the United States, EMA decided to add a warning about the small risk of blood clots in the package insert, but still recommends its use in the European Union (EU).
At the PRAC safety meeting this Tuesday, EMA, European scientists concluded that “These events should also be included as very rare side effects.” As of April 13, the vaccine has been accepted by 7 million people. United States, Countries/regions that have suspended the use of Janssen before investigating these thromboembolic events.
European regulators said that all cases occurred in people under the age of 60, and within three weeks after vaccination, most of them were women. The organization warned that based on current evidence, “The specific risk factors have not yet been determined”, For example, the development of these symptoms such as age, gender and medical history.
The agency believes that medical professionals and patients receiving medical insurance Jensen Vaccine “They should be aware of the possibility of blood clotting and lower platelet levels in rare cases within 3 weeks after surgery. Vaccination“.
However, in addition to adding this information to the product, EMA also believes that the risk associated with covid-19 (a disease that may cause the patient to be hospitalized or die) is still greater than the risk of possible clotting, so ” General interest Vaccine Overcoming risk side effect”.
In addition, he added that the use of available covid-19 vaccines will take into account the “pandemic situation and vaccine availability” in different EU countries, and pointed out that the “reasonable explanation” for these cases is that they are similar to those in heparin treatment. The “immune response”.
With these conclusions, European countries will now decide what steps to take against Janssen. This is the hope of many countries because it is the only single-dose vaccine available in this community area, and several countries have received the first dose last week . They keep it until they get the opinion of the decision maker before making a decision. EMA.