(Artwork: vovidzha / Shutterstock)
At its meeting on April 20, the EMA safety committee concluded that the warning of abnormal blood clotting should be added to the product information of the vaccine COVID-19 Janssen, developed by Janssen. , a subsidiary of Johnson & Johnson.
The committee said that blood clots should be listed as a “very rare side effect” of the vaccine.
The Commission added that it has reviewed “all available evidence” including eight reports from the United States of serious cases involving abnormal blood clots and low platelet counts. , and one of them leads to death.
All of these occurred within 3 weeks of vaccination in people younger than 60 years of age, mostly women.
The EMA says “specific risk factors” has not been confirmed based on available information.
The safety committee notes that blood clots occur “primarily at abnormal sites” such as in the cerebral veins and the abdomen as well as in the arteries, with low and double blood platelets. when causing bleeding.
The EMA says health care professionals and those who will be vaccinated “should be aware that blood clotting is very rare in combination with a low platelet count within 3 weeks of vaccination. strains ”.
The US licensed the J&J vaccine last month and has used more than 7 million doses as of April 13.
The vaccine was also approved for use in the European Union on March 11, but development of the J&J vaccine has yet to proceed.
Previously, another COVID-19 vaccine, AstraZeneca, was under investigation by EMA after reports of blood clots following vaccination emerged.
The agency concluded on April 7 that “there may be” a link between the vaccine and the blood clot, but countries still recommend the vaccine, arguing its benefits. more than the risk.
The Janssen vaccine-related blood clotting cases are “very similar” to those occurring after the AstraZeneca vaccine, the EMA said on Wednesday.