The European Medicines Agency (EMA), the European Union’s drug regulator, issued a warning on Friday that a possible link between Johnson & Johnson’s COVID-19 vaccine and rare cases of blood clotting in deep veins has been found.
During a Pharmacovigilance Risk Assessment Committee meeting, the agency spoke out that it had found a possible link between venous thromboembolism (VTE) and the J&J vaccine.
“VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences,” the agency wrote. It went on to recommend that the condition be listed as a rare side effect.
The agency also would like to see immune thrombocytopenia (ITP) be listed as a side effect of both the J&J vaccine and AstraZeneca’s vaccine. It defined ITP as a bleeding disorder in which “the immune system mistakenly targets blood cells called platelets that are needed for normal blood clotting.”
J&J has previously said that the conditions are rare, but it has agreed to update the product information based on these findings. It has also pledged to continue to work closely with EMA and other government agencies, according to Reuters.
“We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated,” J&J said in a July statement.
In this same statement, J&J admitted to potential complications from its vaccine.
“Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen COVID-19 vaccine,” the company said at the time. “Most occurred within 42 days after vaccination. While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome.”
“Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization, and other health authorities around the world where our vaccine is authorized,” J&J added.
This all just goes to show that people have more than enough of a reason to question the safety of these COVID-19 vaccines. These shots were rushed into production, and there’s no telling what complications will arise from them down the road. That’s why the decision on whether or not the vaccine should be left up to individuals rather than the government.