EU Launches Investigation of Possible Side Effects of mRNA Vaccines
A skin condition and two types of kidney problems may be linked to vaccines
Another bump in the road for the mRNA vaccines.
In June 2021, the FDA required Pfizer-BioNech and Moderna to put a warning label on their vaccines, alerting users to a rare possible side effect of heart inflammation in some individuals. After an intensive study, regulators concluded that the benefits outweighed the risks.
Now, three new possible side effects are being studied in the EU, after reports of adverse reactions to the Pfizer and Moderna Covid-19 vaccines.
- Erythema multiforme - a dermatological condition causing skin lesions, which may also affect mucous membranes inside the body's internal cavities. Symptoms include skin or mouth lesions that have a pink-red center surrounded by a pale ring border and an outer pink-red ring. The lesions can sometimes be painful or itchy.
- Nephrotic syndrome - a kidney disorder which causes the kidneys to pass too much protein in the urine. Usually, nephrotic syndrome is caused by damage to the clusters of small blood vessels in the kidneys that filter waste and excess water from the blood.
- Glomerulonephritis - a type of kidney disease in which the tiny filters in the kidneys that help filter waste and fluids from the blood are damaged.
Symptoms for both kidney disorders can include foamy or bloody urine, fatigue, and swelling of the hands, feet, eyelids or abdomen.
The EMA (European Medicines Agency) is currently investigating whether these reported conditions are actually side effects of the mRNA vaccines. Some of the individuals involved had pre-existing kidney problems.
The EMA's Pharmacovigilance Risk Assessment Committee has requested more data from Pfizer-BioNTech and Moderna. The companies are cooperating.
"We take adverse events that are potentially associated with our COVID-19 vaccine, BNT162b2, very seriously. We closely monitor all such events and collect relevant information to share with global regulatory authorities." - statement released by Pfizer
The EMA did not reveal how many people have reported these potential side effects.
Over 330 million doses of Pfizer-BioNTech have been administered in Europe, in conjunction with over 43 million doses of Moderna.
So far, scientists agree that the vaccines' benefits outweigh the risks.
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