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The European Medicines Agency (EMA) has announced that it will convene an ad hoc expert group to provide “additional input” into the assessment of thromboembolic events occurring in European Union (EU) residents who have received AstraZeneca’s COVID-19 vaccine.
The group will meet this coming Monday, EMA noted in an update today.
Several EU countries stopped using the AstraZeneca COVID-19 vaccine in mid-March following reports of blood clots in vaccinated individuals.
Last week, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded its preliminary review of events involving blood clots, some with “unusual features” such as low numbers of platelets, that have occurred in some people who received the vaccine.
The committee concluded that the vaccine is not associated with an increase in the overall risk of blood clots and that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects, as reported by Medscape Medical News.
However, the committee recommended adding more information and advice for healthcare professionals and the public in the vaccine’s product information.
The letter to healthcare professionals notes that “the combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca.”
It advises healthcare professionals to “be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia.”
PRAC is continuing its assessment of the reported cases. The ad hoc group to meet on Monday will include external experts in hematology, cardiovascular medicine, infectious diseases, virology, neurology, immunology and epidemiology.
The group will give PRAC their views on aspects such as “any plausible mechanism of action, possible underlying risk factors and any additional data needed to gain a deeper understanding of the observed events and the potential risk,” the EMA said.
This expert group will also include two representatives from the public.
“The outcome of the expert meeting, together with further analysis of the reported cases, will feed into PRAC’s ongoing evaluation. The PRAC’s updated recommendation on the issue is expected during its April plenary meeting (April 6-9),” the EMA said.