(Reuters) – Europe’s drug regulator on Friday advised against using AstraZeneca’s COVID-19 vaccine in people with a history of a rare bleeding condition and said it was looking into heart inflammation cases after inoculation with all coronavirus shots.
The European Medicines Agency’s (EMA) safety committee in its evaluation said that capillary leak syndrome must be added as a new side effect to labelling on AstraZeneca’s vaccine.
It is a condition in which blood leaks from the smallest of vessels into muscles and body cavities and is characterised by swelling and a drop in blood pressure.
The regulator first began looking into these cases in April and the recommendation adds to AstraZeneca’s woes after its vaccine has been dogged with problems, including a possible link to rare blood clotting issues.
Last month, the EMA had advised against using the second AstraZeneca shot for people with the clotting conditions.
The watchdog is also broadening its probe into cases of myocarditis and pericarditis following inoculation with AstraZeneca’s vaccine and other shots from Pfizer, Moderna and J&J.
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