Europe’s medicines regulator has announced it has asked a group of experts to provide their views on links to blood clots purportedly associated with some Covid-19 vaccines.
In a statement published on its website on Thursday, the European Medicines Agency (EMA) announced the new group will meet with the Pharmacovigilance Risk Assessment Committee (PRAC) on March 29 to discuss the possible reasons why some people developed blood clots after receiving a Covid-19 vaccine “to gain a deeper understanding of the observed events and the potential risk.”
The new group includes experts in hematology, cardiovascular medicine, infectious diseases, virology, neurology, immunology and epidemiology.
The outcome of the meeting will feed into PRAC’s ongoing evaluation around blood clots links to the Covid-19 vaccine, with any updated recommendations expected to be announced during its April plenary meeting, which takes place between April 6 and April 9.
The EMA's announcement comes after its safety committee said on March 18 that investigations into the link between the Oxford-AstraZeneca vaccine and blood clots had come to a clear scientific conclusion:
“This is a safe and effective vaccine,” EMA Executive Director Emer Cooke told a news conference after the committee had concluded.
However, the committee said it was unable to “rule out definitively” a possible link to blood clots.
This led to the committee recommending vaccine patient information leaflets and information be provided to health care professionals and updated to include warnings about potential side effects, including low platelet levels and blood clotting disorders. The new updated advice is now available of their website
Meanwhile, the World Health Organization’s Global Advisory Committee on Vaccine Safety said Friday that current available data does not indicate that recent reported blood clots following administration of AstraZeneca are connected to the vaccine.
The committee noted that people naturally develop blood clots, and Covid-19 infection can also cause them. It said observed rates of these events have actually been lower than expected. Just because someone suffers a blood clot and was also recently vaccinated does not mean the vaccine caused the clot, the committee said.