What does the EMA recommend for people who will be immunized with Janssen

The Janssen / Johnson & Johnson vaccine is the last option approved in the European Union to protect against covid-19. Clinical trials, carried out in part in Spain, support the efficacy of this serum. In addition, it is the first regimen that requires a single dose and can be stored and distributed at refrigerator temperature (between 2 and 8 ºC), even for a maximum of 12 hours at room temperature (up to 25 ºC).

The pharmacovigilance committee of the European Medicines Agency (EMA), known as PRAC, has found a possible link between rare cases of thrombosis and low platelets related to the administration of the vaccine after identifying eight cases in the United States, where more than seven million people have received it.

The EMA insists on seeking immediate medical assistance with the following symptoms: shortness of breath, chest pain, leg swelling, persistent abdominal or belly pain, neurological symptoms and small spots of blood under the skin

Despite these very rare cases of thrombosis with thrombocytopenia (low platelets), the European drug regulator emphasizes that Benefits of this vaccine outweigh these potential risks.

However, it requests the population that can receive this vaccine to be attentive to any complications during the three weeks following administration and to seek immediate medical assistance if they present the following symptom: shortness of breath, chest pain, leg swelling, persistent abdominal or belly pain, neurological symptoms (severe and persistent headache or blurred vision), and small spots of blood under the skin beyond the injection site .

The role of toilets

The EMA has advised professionals that these rare cases of thrombosis with thrombocytopenia include venous thromboses in unusual locations, such as cerebral venous, splanchnic and arterial sinuses. All the investigated cases occurred in children under 60 years of age, within three weeks of vaccination and in a majority of women. Only one of the people who suffered these thromboses with thrombocytopenia died.

Healthcare providers should be aware of the signs and symptoms of thromboembolism and thrombocytopenia in order to quickly treat those affected

“Healthcare workers must be aware of the signs and symptoms of thromboembolism and thrombocytopenia in order to be able to quickly treat affected people according to available guidelines,” they stated.

Cases similar to AstraZeneca

The cases reviewed by the agency’s experts were very similar to those that occurred with the vaccine developed by AstraZeneca, Vaxzevria.

“In terms of mechanism, it is believed that the vaccine can trigger an immune response that leads to a disorder similar to heparin-induced thrombocytopenia. At this time, the pathophysiological mechanism has not been established, and it is currently not possible to identify specific risk factors ”, they concluded.

Fountain: EMA

Rights: Creative Commons.