The European Medicines Agency (EMA) announced on Aug. 11, 2021 that it is investigating a possible link between the experimental messenger RNA (mRNA) biologics developed by Pfizer/BioNTech and Moderna/NIAID and an allergic skin condition called erythema multiforme, as well as two kidney disorders known as glomerulonephritis and nephrotic syndrome.1 2
Symptoms of erythema multiforme are the appearance of “symmetrical, red, raised skin areas” all over the body. The allergic reaction can cause itching, cold sores, fatigue, joint pain and fever.3
According to a paper describing the reaction and summarizing treatment options published in American Family Physician:
Erythema multiforme s an immune-mediated reaction that involves the skin and sometimes the mucosa. Classically described as target-like, the erythema multiforme lesions can be isolated, recurrent, or persistent.4
Glomerulonephritis (GN) is characterized by inflammation of the “tiny filters” (glomeruli) in the kidneys that remove “excess fluid, electrolytes and waste” from the bloodstream and pass them into the urine. Severe or chronic glomerulonephritis can damage the kidneys.5
According to Cleveland Clinic, GN can develop secondary to endocarditis (infection of heart valves), other viral infections, diseases that inflame the blood vessels, and when the immune system attacks healthy parts of the body, such as with lupus, an autoimmune disease.6
Nephrotic syndrome (NS) occurs when there is damage to the “clusters of small blood vessels” in the kidneys that “filter waste and excess water” from the blood. The condition causes swelling, notably in the feet and ankles, and it can increase the risk of infections and blood clots.7
A recent study published in the Journal of the American Society of Nephrology evaluated kidney, cardiovascular, and mortality outcomes in adults with primary nephrotic syndrome and found that they were at increased risk for end stage kidney disease (ESKD), acute coronary syndrome, heart failure, ischemic stroke, venous thromboembolism and death.8
The EMA did not say how many people may have suffered from these two reported adverse events involving an allergic skin reactions or kidney disease following reciept of Pfizer/BioNTech’s BNT162b2, which is also known as “Comirnaty”9 and Moderna/NIAID’s mRNA-1273, also known as “Spikevax.”10 The European health agency confirmed that 330 million doses of Pfizer’s BNT162b2 and 43.5 million doses of Moderna’s mRNA-1273 have been administered in the European Economic Area (EEA) as of July 29.1 2
Other Safety Problems for COVID Shots in Europe and the U.S.
There have also been safety concerns in Europe with regard to the experimental AZD1222 and Ad26.COV2.S adenovirus vaccines developed by AstraZeneca/Oxford University and Johnson & Johnson/Janssen respectively. The concerns involve reports of blood clots in people who received these vaccines. On Apr. 14, the European Commission (EC) decided not to renew production and delivery contracts for Astra Zeneca’s AZD1222 and J&J’s Ad26.COV2.S.2 7
In June, the U.S. Food and Drug Administration (FDA) added warning labels to Pfizer’s BNT162b2 and Moderna’s mRNA-1273 after determining a “likely link” between these pharmaceutical products and cases of heart inflammation (myocarditis) in the United States.11 In July, the FDA added a warning label to J&J’s Ad26.COV2.S linking the vaccine to cases of a paralyzing neurological disorder known as Guillain-Barré syndrome (GBS).12
The EMA recently recommended that immune thrombocytopenia (low blood platelets leading to internal bleeding), dizziness, and tinnitus (ringing in the ear) be added as potential side effects to the label of J&J’s Ad26.COV2.S and GBS be added as a possible reaction to AstraZeneca’s AZD1222.13
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1 Aripaka P. EU regulator looking at new possible side-effects of mRNA COVID-19 shots. Reuters Aug. 11, 2021.
2 Dunleavy K. Pharma Pfizer, Moderna COVID vaccines face new safety probe in Europe over possible link to skin condition, 2 kidney disorders. Fierce Pharma Aug. 11,2 2021.
3 Johns Hopkins Medicine. Erythema Multiforme.
4 Trayes KP, Love G, Studdiford TS. Erythema Multiforme: Recognition and Management. American Family Physician 2019; 100(2): 82-88.
5 Mayo Clinic. Glomerulonephritis.
6 Cleveland Clinic. Glomerubnephritis (GN). Nov. 4, 2020.
7 Kansteiner F. Europe won’t renew AstraZeneca, Johnson & Johnson COVID-19 vaccine contracts next year: report. Fierce Pharma Apr. 14, 2021.
8 Go AS, Tan TC, Chertow GM et al. Primary Nephrotic Syndrome and Risks of ESKD, Cardiovascular Events and Death: the Kaiser Permanente Nephrotic Syndrome Study. J Am Soc Nephrol 2021; 32(8).
9 Bulik BS. The inside story behind Pfizer and BioNTech’s new vaccine brand name, Comirnaty. Fierce Pharma Dec. 23, 2020.
10 Bulik BS. Moderna locks up Spikevax name in Europe, joins Pfizer Comrinaty in wait for official brand approval in U.S. Fierce Pharma June 30, 2021.
11 Dunleavy K. Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk, FDA says. Fierce Pharma June 24, 2021.
12 Weixel N. FDA adds new warning to J&J COVID-19 vaccine. The Hill July 12, 2021.
13 Aripaka P. No link found so far between menstrual disorders and COVID-19 vaccines, EU says. Reuters Aug. 6, 2021.