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26-03-2021 15:04 |
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COVID-19
Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases |
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Last week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very rare cases of blood clots with unusual features such as low numbers of platelets, in people vaccinated with COVID-19 Vaccine AstraZeneca. The committee confirmed 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. The committee recommended including more information and advice for healthcare professionals and the public in the vaccine’s product information. The amended
product information and the associated direct
healthcare professional communication are now available on the EMA
website. PRAC is continuing its
assessment of the reported cases. In this context, EMA is convening an ad hoc expert group
on 29 March to provide additional input into the assessment. External experts
in haematology (thrombosis and haemostasis), cardiovascular medicine,
infectious diseases, virology, neurology, immunology and epidemiology will
meet to provide their views to PRAC 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. 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 (6–9 April). More about the procedure The review of thromboembolic
events with COVID-19 Vaccine AstraZeneca is being carried out in the context
of a safety signal, under an accelerated timetable. A safety signal is
information on a new or incompletely documented adverse event that is
potentially caused by a medicine such as a vaccine and that warrants further
investigation. The review is being carried out
by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the committee
responsible for the evaluation of safety issues for human medicines. Once the
review is completed, PRAC will make any recommendations necessary to minimise
risks and protect patients’ health. (ΜΚΥ) |
