The European Union drug regulator said on Tuesday it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and “very rare cases of unusual blood clots” – but that the benefits of the injection still outweigh the benefits of the injection. risks.
The European Medicines Agency said in a statement that its safety committee concluded that a “warning of unusual low platelet blood clots 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 associated with low platelet counts 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 platelets is very rare, and the overall benefits of COVID-19 vaccine Janssen in preventing COVID-19 outweigh the risks of side effects. “
To reach its conclusion, the agency said it had taken into account all currently available evidence, including eight reports from the United States of serious cases of unusual blood clots, one of which was fatal.
![The European Medicines Agency said: “all cases [involving the blood clots] occurred in people under 60 years of age within three weeks of vaccination, the majority in women.](https://nypost.com/wp-content/uploads/sites/2/2021/04/jj-vaccine-europe-99.jpg?quality=90&strip=all&w=2000)
Last week, Johnson & Johnson announced it would delay the rollout of its COVID-19 vaccine in Europe due to concerns about possible blood clots in recipients in the US.
On Tuesday, following the EMA statement, the company said it would resume shipments to Europe, CNN reported.
US officials recommended a break in vaccination states last week, after six recipients developed blood clots, including one who died.
To date, nearly 7 million people in the US have gotten the Johnson & Johnson shot.
‘All cases [involving the blood clots] occurred in people under 60 years of age within three weeks of vaccination, the majority in women. Based on currently available evidence, specific risk factors have not been confirmed, ”said the European Medicines Agency.
The EMA safety committee “noted that the blood clots usually occurred in unusual places, such as in veins in the brain (cerebral sinus vein thrombosis, CVST) and abdomen (splanchnic venous thrombosis) and in arteries, along with low platelet counts and sometimes bleed. “
“The cases studied were very similar to those that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria,” the agency said.
The EMA also previously said there is a “possible association with very rare cases of unusual low platelet blood clots” and the AstraZeneca COVID-19 vaccine and said this should be listed as “very rare side effects” of the vaccine.
The agency explained in its statement Tuesday that the cases it reviewed related to unusual blood clots “were very similar to those that occurred with the COVID-19 vaccine developed by AstraZeneca.”
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