what the EMA warning is and what it says

This is a very rare disorder, which can also be caused by Covid, for which the European Medicines Agency has recommended adding this contraindication to the Spikevax vaccine for those who have had a previous episode.

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The European Medicines Agency (EMA) has issued a new warning on capillary leak syndrome (CLS) which will lead to the inclusion of a new contraindication to Moderna’s Covid vaccine for people with previous capillary leak syndrome (CLS), a very rare but serious disorder, which can also be caused by Covid and other viral infections, as well as by some types of blood cancer, inflammatory diseases and drug treatments. The syndrome, reminds the EMA, causes fluid to leak from small blood vesselsthe capillaries, rapidly causing swelling of the arms and legs, sudden weight gain, feeling faint, thickening of the blood, low blood albumin and low blood pressure.

Capillary leak syndrome: what the EMA warning says

At its latest meeting (7-10 March), EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended adding to the vaccine product information Spikevax by Moderna a warning about flare-ups of capillary leak syndrome (CLS). The PRAC, reports the drug regulatory body of the European Union, evaluated all available data and all cases of CLS reported in the Eudravigilance database after the administration of Moderna and Pfizer / BioNTech’s Covid-19 mRna vaccines ( Comirnaty), examining altogether 55 reports of CLSof which 11 after vaccination with Spikevax out of approximately 559 million doses administered and 44 with Comirnaty out of 2 billion doses administered.

The Committee concluded that “there is insufficient evidence to establish a causal association between the two vaccines and the emergence of new cases of CLS” while recommending the inclusion of a warning in the product information relating to the Moderna vaccine, so long as “some cases of CLS exacerbation indicated an association with Spikevax, while cases reported after vaccination with Comirnaty did not support this association ”.

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Previously, the PRAC had made the same recommendation for Covid-based viral vector vaccines Johnson & Johnson (Janssen) and for that of Astrazeneca (Vaxzevria), advising against the use of these two vaccines in people with previous capillary leak syndrome. Similarly, Moderna’s new vaccine indication (Spikevax) aims to update health care professionals on the points raised by the risk assessment of flare-up of capillary leak syndrome after vaccination and to raise patient awareness of the potential risk of flare-ups. .

What is Capillary Leak Syndrome

As mentioned, capillary loss syndrome is a very rare but serious condition that causes fluid loss from small blood vessels (capillaries), resulting in swelling, mainly in the arms and legs, sudden weight gain, low blood pressure, increased density blood and low blood levels of albumin (an important blood protein). Although the likelihood of this condition occurring following vaccination is very low, those experiencing these symptoms should seek immediate medical attention so that they can receive a quick diagnosis, seek prompt treatment and avoid complications. Symptoms can also be associated with feeling faint (due to low blood pressure).

Covid can also trigger it

Cases of capillary leak syndrome have been reported in the literature associated with Sars-Cov-2 coronavirus infection. In general, this condition rarely occurs in the general population, with fewer than 500 cases described in the literature worldwide (National Organization for Rare Disorders), although these estimates are likely to be lower than the true frequency of the event.

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Videogames entered his life in the late '80s, at the time of the first meeting with Super Mario Bros, and even today they make it a permanent part, after almost 30 years. Pros and defects: he manages to finish Super Mario Bros in less than 5 minutes but he has never finished Final Fight with a credit ... he's still trying.

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