EU Investigating More Side Effects From mRNA COVID Vaccines

European Union regulators are now looking into three new reported side effects from COVID-19 vaccines. This involves vaccines that utilize messenger RNA or mRNA. It’s a type of vaccine that uses a copy of an mRNA molecule to produce an immune response.  

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Three Side Effects Reported For Moderna and Pfizer-BioNTech vaccines

The success of the mRNA technology in warding off COVID-19 helped the entire world. Due to the unprecedented speed at which the vaccines received emergency authorization, there was not enough time to study any long-term side effects.

During the course of administering the vaccines, some reported side effects. These include fever, fatigue, headache, muscle pain, chills, diarrhea, and pain at the injection site. Most symptoms went away after a few hours. 

However, regulators are studying some rare side effects that appear in some patients. A small number of people reported three distinct conditions after getting vaccinated with the Pfizer-BioNTech and Moderna vaccines.

As a result, the European Medicines Agency initiated a study to learn more about these side effects. “Further data and analyses have been requested from the marketing authorization holder to support the ongoing assessment,” the agency said. 

Three New Side Effects Reported

The three side effects involve the skin and the kidney. The first one, erythema multiforme, is a form of allergic skin reaction. Meanwhile, the second one is glomerulonephritis or inflammation of the kidneys. The third side effect is nephrotic syndrome, a kidney disorder that causes a leak of excessive protein in the urine. 

All three are now under study by the safety committee of the European Medicines Agency (EMA), according to the regulator. The agency's Pharmacovigilance Risk Assessment Committee is now attempting to establish if the three conditions are actual side effects in each vaccine. 

Benefits Still Weigh The Risks

Earlier last month, the EMA also discovered a possible link between mRNA vaccines and very rare heart inflammation. Despite the possible risks, the EMA and the World Health Organization have repeatedly stressed that everybody should still get vaccinated for COVID-19. They emphasized that the benefits of these vaccines outweigh any risks. 

Pfizer, Europe’s biggest supplier of COVID-19 vaccines to the European Union, and Moderna have yet to respond and comment on the matter. 43.5 million doses of Spikevax, Moderna’s COVID-19 vaccine, already made it to the shoulders of millions of Europeans.

Meanwhile, Comirnaty, Pfizer’s vaccine co-developed with German company BioNTech, already administered more than 330 million doses. 

Assessments Part of Routine Updates

The EMA did not provide any details on the number of side effects cases. However, the agency said they already requested more data from vaccine companies. At the moment, the EMA is not requiring either Moderna or Pfizer to change the labeling of their vaccines.  

In addition, the EMA said that new assessments are part of routine updates to the safety section of all authorized vaccines' databases. Recently, it recommended adding menstrual disorders as a condition from getting the vaccines. This applies to vaccines from AstraZeneca and Johnson & Johnson.

Watch the JAMA Network FAQ on COVID-19 Vaccines: August 2021 Update:

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