Covid vaccines, Ema updates AstraZeneca, J&J, Pfizer and Moderna ‘leaflet’

Vaccines Covid, the European Medicines Agency modifies the indications based on the possible “but rare” side effects of AstraZeneca, J&J, Moderna and Pfizer. The update of the leaflet to notify both health professionals and those who receive it, signing the informed consent. Let’s see what changes: Pfizer and Moderna “Very rare cases” of myocarditis and pericarditis can occur after the anti-Covid vaccination with Comirnaty (Pfizer / BioNTech) and Spikevax (Moderna). Experts from the European Medicines Agency’s Pharmacovigilance Committee (Prac) considered a link between cardiac inflammation and mRna vaccines “possible” and therefore recommended “listing myocarditis and pericarditis as new side effects in the product information for these. vaccines “. Together, the PRAC suggests inserting “a warning to raise awareness among health professionals and people who take these vaccines.” “Myocarditis and pericarditis are inflammatory conditions of the heart – recalls the Ema – Symptoms can vary, but often include shortness of breath , rapid heartbeat which may be irregular (palpitations) and chest pain “. The Prac considered “all the evidence currently available”, the agency specifies, including “an in-depth review of 145 cases of myocarditis” registered “in the European Economic Area (SEE) among people who received Comirnaty and 19 cases among people who received Spikevax “. The Committee also reviewed “the reports of 138 cases of pericarditis following the use of Comirnaty and 19 cases after Spikevax”. The Prac also analyzed the reports “received all over the world”. As of May 31, 2021, “about 177 million doses of Comirnaty and 20 million doses of Spikevax” had been administered in the See area. AstraZeneca Guillain-Barré syndrome ( Gbs) will be included as a warning in the product information of AstraZeneca’s Covid Vaxzevria * vaccine. This was decided by the Pharmacovigilance Committee (Prac) of the European drug agency EMA, even if “at this stage the available data do not confirm or exclude a possible association” between GBS and the vaccine. The syndrome, the experts recall, is “a immune system disorder that causes inflammation of the nerves and can cause pain, numbness, muscle weakness and difficulty walking. ” GBS had already been identified during the product’s marketing authorization process as “a possible adverse event that requires specific safety monitoring activities.” Johnson & Johnson The European Medicines Agency Ema advises against the use of the anti-vaccine Janssen’s Covid (Johnson & Johnson) in people with a history of capillary leak syndrome. The Pharmacovigilance Committee (Prac) of the EU regulatory body recommends not using the adenoviral product in those who suffer or have suffered from these diseases. A “very rare and serious condition – the experts recall – which causes fluid loss from small blood vessels, resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin”. also to “add capillary leak syndrome to the product information as a new side effect of the” J&J vaccine, “along with a warning to raise awareness among healthcare professionals and patients about this risk”. The EMA Prac examined “3 cases of capillary leak syndrome in people who had received the Janssen vaccine, which occurred within 2 days of vaccination – the agency specifies – One of the affected people had a history of capillary leak syndrome and 2 subsequently died “. For this “health professionals must be aware of the signs and symptoms of capillary leak syndrome and its risk of recurrence in people who have previously been diagnosed with this condition.” worldwide “over 18 million doses of J&J vaccine”.