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| EU drugs regulator investigating possible new adverse effects from Pfizer and Moderna Covid vaccines | EU drugs regulator investigating possible new adverse effects from Pfizer and Moderna Covid vaccines |
| (17 days later) | |
| 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. | 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. | 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. | 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. | 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. |
| In July, the EMA recommended adding myocarditis and pericarditis, or inflammation of the heart, to the list of possible rare side effects on the warning label of the two mRNA vaccines after assessing several hundred reports. | In July, the EMA recommended adding myocarditis and pericarditis, or inflammation of the heart, to the list of possible rare side effects on the warning label of the two mRNA vaccines after assessing several hundred reports. |
| Despite the rare adverse reactions flagged by the agency, it says that on balance the benefits of vaccination against Covid far outweigh the risks. | Despite the rare adverse reactions flagged by the agency, it says that on balance the benefits of vaccination against Covid far outweigh the risks. |
| More than 43.5 million doses of Moderna’s Spikevax and 330 million jabs of Pfizer-BioNTech’s Comirnaty have been administered across the EU, according to the EMA’s data. | More than 43.5 million doses of Moderna’s Spikevax and 330 million jabs of Pfizer-BioNTech’s Comirnaty have been administered across the EU, according to the EMA’s data. |
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