The European Medicines Agency also wants Pfizer and Johnson & Johnson to update warnings and lists of side effects relating to face swelling (Pfizer) and blood clots (J&J).
EU regulators Friday called on Pfizer and Moderna to provide additional data related to the companies’ COVID vaccines and a potential link to heart inflammation, after the agency completed a safety review of all four COVID vaccines authorized for emergency use in the EU.
EU wants data on heart inflammation, but European Commission also approves Merck's marketing authorization for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat).
In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world.
The European Medicines Agency (EMA) has said it is investigating three new possible side effects that may be linked to mRNA Covid vaccines made by Pfizer and Moderna, after reports of allergic skin reactions and kidney disorders.
Europe’s medicines watchdog issued statements on Wednesday confirming that its Pharmacovigilance Risk Assessment Committee (PRAC) is looking into whether three medical conditions are connected to the administration of Covid jabs made by Pfizer and Moderna, after being made aware of a “small number” of incidences.
One of the three potential side effects being investigated is a skin disorder called erythema multiforme, an allergic reaction which manifests as reddish-purple skin lesions, sometimes around the mouth, eyes and other moist cavities on the body.
The two other conditions the PRAC is assessing for any link to the Pfizer and Moderna vaccines are related to the kidneys, with one disorder linked to inflammation of filters in the organ. The other, nephrotic syndrome, causes the kidneys to leak excess protein into the urine, which can then appear bloody or foamy. Symptoms of the disorder also include swollen eyelids, feet and abdomen, and fatigue. Some cases occurred in people with a history of kidney conditions.