WHO AND EMA expert panel confirms safety of AstraZeneca's vaccine after clotting reports
In a recent update, the World Health Organization (WHO) and the European Medicines Agency (EMA), combinedly has put forward a declaration that benefits of preventing hospitalization and death from COVID-19 outweigh the possible risks of thromboembolic events and thrombocytopenia, which are clearly rare, after receiving AstraZeneca's COVID-19 vaccine.
The vaccine had been put on hold after 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST were reported in patients receiving the doses, urging an immediate investigation on the safety of the vaccine.
The Committee's experts looked in extreme detail at records of DIC and CVST reported from Member States, 9 of which resulted in death. Most of these occurred in people under 55 and the majority were women. "Because these events are rare, and COVID-19 itself often causes blood clotting disorders in patients, it is difficult to estimate a background rate for these events in people who have not had the vaccine."the panel opined.
Moving a step further to ensure safety , the expert panel has advised that , though rare,if symptoms suggestive of clotting problems occur patients should seek immediate medical attention and inform healthcare professionals of their recent vaccination. Also,Steps are already being taken to update the product details for the vaccine to include more information on these risks.
Key highlights from the declaration has been provided below.
The Committee confirmed that:
- The benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
- The vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
- There is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
- However , the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).
For the full article follow the link: Press briefing on the conclusion of the investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events by the Pharmacovigilance Risk Assessment Committee (PRAC) (18/03/2021)