Covid vaccines, the new indications on the adverse reactions of the EMA: “Janssen not recommended for people with capillary leak syndrome”. Experts: “Possible link with myocarditis after Pfizer and Moderna”

As had already happened with the Astrazeneca vaccine theEuropean Medicines Agency (Ema) does not recommend the use of the anti-Covid vaccine of Janssen (Johnson & Johnson) in people with history of capillary leak syndrome. The Pharmacovigilance Committee (Prac) of the EU regulatory body recommends not to use the adenoviral product in those who suffer or have suffered from these diseases. A “very rare and serious condition – the experts recall – that 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”.

The Prac also indicates to “add capillary leak syndrome to the product information as a new side effect of the vaccine“J&J,” along with a warning to raise awareness among healthcare professionals and patients about this risk. ” The PRAC evaluated three cases of capillary leak syndrome in people who received the Janssen vaccine, within two days of the vaccine. One of them had a history of the syndrome, two later died. As of June 21, an additional 18 million doses of the vaccine have been administered worldwide.

Again with regard to Vaxzevria, the product information of the vaccine developed by the Oxford researchers will be inserted as a warning sindrome di Guillain-Barré (Gbs). A decision of the Pharmacovigilance Committee (Prac) of the European Medicines Agency Ema, although “at this stage the data available they neither confirm nor exclude a possible association“. The syndrome, experts recall, is “a disorder of the immune system that causes inflammation of the nerves and can cause pain, numbness, muscle weakness and difficulty walking“. GBS had already been identified during the product marketing authorization process as “a possible adverse event that requires specific safety monitoring activities”.

As regards messenger RNA vaccines, the EMA reports “very rare cases” of myocarditis and pericarditis with Comirnaty (Pfizer / BioNTech) and Spikevax (Moderna). Experts considered a link between cardiac inflammation and mRna vaccines “possible”, thus recommending “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 – Ema recalls – Symptoms can vary, but often include shortness of breath, rapid heartbeat that can be irregular (palpitations) and chest pain ”. The Prac took into consideration “all the evidence currently available”, states the agency, including “a thorough review of 145 cases of myocarditis“Registered” in the European Economic Area (See) between 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.

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