The committee said 18 deaths had been reported in its review of 62 cases of CVST (a coagulation in the sinuses that drain blood from the brain) and 24 cases of splanchnic venous thrombosis (in the abdomen) reported in an EU drug safety database. The cases came mainly from spontaneous reporting systems in the European Economic Area and the United Kingdom, where a total of around 25 million people had received the vaccine, it noted.
The agency announced its conclusion when the UK Medicines and Healthcare Products Regulatory Agency held a press conference on the same subject five days after its weekly report confirmed that at least 22 people had experienced CVST and at least eight cases of low platelet thrombosis. , which is a relatively rare combination.
EMA Executive Director Emer Cooke told a news conference on Wednesday that the agency would add blood clots and platelet counts to its list of possible side effects from the vaccine, but added that the safety committee “has confirmed that the benefits of the AstraZeneca vaccine in the prevention of Covid -19 outweigh the the risk of side effects “and that the EMA’s recommendations for the use of the vaccine did not change.
The EMA’s statement urged healthcare professionals and people receiving the vaccine “to remain aware of the possibility of very rare cases of blood clots combined with low levels of platelets occurring within 2 weeks of vaccination.”
“So far, most of the reported cases have occurred in women under 60 within 2 weeks of vaccination. Based on the evidence currently available, specific risk factors have not been confirmed,” the statement said, although Cooke said no one was clear. risk profile found when the safety committee examined the age and sex of individuals who reported these rare side effects.
This is a groundbreaking story, more to follow …