Tuesday, June 22, 2021

Covid-19: EU advises adding a condition to the AstraZeneca label

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LONDON: The European Medicines Agency says it is recommending that people who have had a rare blood vessel syndrome not be immunized with AstraZeneca’s Covid-19 vaccine.
In a statement on Friday, the EU drug regulator said it reviewed the cases of six people who had capillary leak syndrome after receiving an injection of the AstraZeneca vaccine. The vaccine has previously been linked to rare blood clots, but health officials say its benefits still outweigh the small risks.
The EMA experts also concluded that the capillary leak condition should be added to the product information as a new side effect of the vaccine.
The agency said it is continuing its review of heart inflammation in a small number of people who developed conditions after being vaccinated with the vaccines made by Pfizer-BioNTech or Moderna Inc.
The EMA said it is studying cases of myocarditis, inflammation of the heart and pericarditis, inflammation of the membrane that surrounds the heart. Symptoms include shortness of breath and chest pain; problems are usually temporary.
“More analysis is needed to determine if there is a causal link to vaccines,” the EU agency said.
The EMA said it expects to finalize its review of such cases next month.
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