The position of European Medicines Agency (EMA’s) safety committee Pharmacovigilance Risk Assessment Committee (PRAC), responsible for assessing all aspects of the risk management of medicines for human use, is that the COVID-19 Vaccine AstraZeneca’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing, reported the agency.
PRAC is already reviewing all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with the vaccine. The EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 Vaccine AstraZeneca. This was decided as a precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died. Some other Member States have also paused vaccination with this vaccine. There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.
The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. As of March 10, 2021, 30 cases of thromboembolic events had been reported among close to five million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.
COVID-19 Vaccine AstraZeneca is a vaccine for preventing COVID-19 in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. COVID-19 Vaccine AstraZeneca does not contain the virus itself and cannot cause COVID-19. The most common side effects with COVID-19 Vaccine AstraZeneca are usually mild or moderate and improve within a few days after vaccination.
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 and that warrants further investigation. Once the review is completed, PRAC will make any recommendations necessary to minimize risks and protect patients' health.
