New Ema warning on capillary leak syndrome (Cls) and Moderna’s anti-Covid vaccine. At its latest meeting (7-10 March), the Prac Pharmacovigilance Committee of the European Medicines Agency recommended adding a warning about Cls exacerbations to the product information for Spikevax *. It is – recalls the Ema – an extremely rare and serious condition that causes fluid to leak from small blood vessels, the capillaries, rapidly causing swelling of the arms and legs, sudden weight gain, feeling of fainting, thickening of the blood, low blood levels of albumin and low blood pressure. The syndrome is often related to viral infections, certain blood cancers, inflammatory diseases, and some drug treatments.
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 / BioNTeche (Comirnaty *). A total of 55 reports of Cls were examined, 11 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.” However, experts have recommended the inclusion of a warning in the product information for Spikevax, to raise health care and patient awareness of the potential risk of Cls exacerbations. 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”.
Healthcare professionals need to be aware of the signs and symptoms of Cls – points out the EMA – and of a possible risk of flare-ups in people with a history of the syndrome. People with prior CLs should consult their treating physician when planning their Covid vaccination.