At the last meeting, the Pharmacovigilance Committee of EMA, the European Medicines Agency, recommended adding to the product information of Spikewax – the vaccine of Modernhighly effective for severe illness, hospitalization and death from Covid-19 – a warning about the possible exacerbation of Czeizel-Losonci syndrome (Cls) for people with a history of capillary leak syndrome. It is an extremely rare and serious condition that it causes fluid leaking from small blood vessels, the capillaries, quickly causing swelling of the arms and legs but also a sudden weight gain, feelings of fainting, thickening of the blood and again low blood levels of albumin and low blood pressure. The warning is to be considered addressed only to those who have suffered from it in the past.
The Prac – reports the EU regulatory body – has evaluated all the available data and all the cases of Cls reported in the Eudravigilance database after the administration of the mRna Covid-19 vaccines from Moderna and Pfizer / BioNTech (Comirnaty). Altogether they have been examined 55 reports of Cls, 11 with Spikevax out of approximately 559 million doses administered e 44 with Comirnaty out of two billion doses administered. Really small numbers that speak for themselves and with respect to which, among other things, “there is insufficient evidence to establish a causal association between the two vaccines and the emergence of new cases of Cls“. However, as proof of the maximum safety and continuous monitoring of the vaccination campaign on a European scale, the experts advised to add a ‘warning about this exacerbation in the product information for Spikevax, to raise awareness among healthcare professionals and patients of the potential but very rare risk of CLs recurrence.
The syndrome is often related to viral infections, some blood cancers, inflammatory diseases, and certain drug treatments. The Prac recommended the warning because “some cases of Cls exacerbations indicated an association with Spikevax, while the cases reported after vaccination with Comirnaty did not support this association”. In short, the link is missing but the association happened with Moderna more than with Comirnaty. Among other things, the indication this is nothing new at all: the Prac had previously formulated the same recommendation for the Johnson & Johnson and Astrazeneca vaccines, those with a viral vector, however, advising against the use of these two vaccines in people with previous capillary leak syndrome. A discouragement that in this case does not seem to be there, limiting itself to an update for healthcare professionals and increasing the awareness of patients on the potential risk of exacerbations. Among other things, the syndrome was in some cases also caused by Sars-CoV-2 infection. However, it should be remembered that this condition rarely occurs in the general population, with fewer con less than 500 cases described in the literature worldwide (National Organization for Rare Disorders), official numbers certainly underestimated but which still give the idea of ​​the disease.
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Source: Vanity Fair
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