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The European Union’s drug regulatory agency said Tuesday that it found a “possible link” between Johnson & Johnson’s single-dose COVID-19 vaccine and “very rare cases of unusual blood clots” — but that the shot’s benefits still outweigh the risks.
The European Medicines Agency said in a statement that its safety committee concluded that a “warning about unusual blood clots with low blood platelets should be added to the product information” for the Johnson & Johnson coronavirus vaccine.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” the agency said.
It added, “COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”
In reaching its conclusion, the agency said it took into consideration all currently available evidence, including the eight reports from the United States of serious cases of unusual blood clots — one of which had a fatal outcome.
Last week, Johnson & Johnson announced it would delay the rollout of its COVID-19 vaccine in Europe amid concerns about potential blood clots in US recipients.
On Tuesday, following the EMA’s statement, the company said it would resume shipments to Europe, CNN reported.
US officials last week recommended a pause in the vaccine stateside, after six recipients developed blood clots, including one who died.
Nearly 7 million people in the US have gotten the Johnson & Johnson shot so far.
“All cases [involving the blood clots] occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed,” the European Medicines Agency said.
The EMA’s safety committee “noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.”
“The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria,” the agency said.
The EMA also previously said there was a “possible link to very rare cases of unusual blood clots with low blood platelets” to AstraZeneca’s COVID-19 vaccine and said that should be listed as “very rare side effects” of the vaccine.
The agency explained in its statement Tuesday that the cases it reviewed involving unusual blood clots “were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca.”
With Post wires
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