European Medicines Agency issues opinion on AstraZeneca vaccine: “It is a safe and effective vaccine”

EMA Executive Director Irish Emer Cooke announced on Thursday. “The committee came to a clear scientific conclusion: this is a safe and effective vaccine”, said the Executive Director of EMA during a video conference.

This announcement was eagerly awaited by several countries, such as France, which have suspended vaccinations with the product AstraZeneca pending a new European scientific opinion. Concern was raised after several cases of bleeding problems or blood clots appeared, sometimes leading to death.

The EMA’s pharmacovigilance risk assessment committee (PRAC) has conducted a specific examination of the cases of thrombosis that have come to its attention in recent days. On Thursday, his verdict fell: it remains recommended to use the vaccine. This is the option that Belgium had also chosen.

“Its benefits in protecting people against Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks“added Ms. Cooke.

Additional exams

On the other hand, the recommendations of the PRAC could lead to a modification of the leaflet of the vaccine produced by the Swedish-British company. “The vaccine is not associated with an increased overall risk of thromboembolic events or blood clots. But during the study, a small number of rare and serious cases of bleeding disorders were seen, which led to further investigation. After days of analysis (including autopsy analyzes) (…), we cannot exclude a link between these cases and the vaccine“, developed Emer Cooke. The PRAC committee therefore recommends communicating about these possible risks and including this information in the leaflet. Concretely, it should be a warning message and a description of the symptoms, among other things so that the population is attentive.

Mrs Straus described these serious cases in more detail, which however remain very rare. Case reports “describe an unusual combination of thrombosis, thrombocytopenia (lack of platelets, editor’s note) and bleeding. In a few cases, small clots have formed in multiple vessels within 7 to 14 days of vaccination. This is referred to as ‘disseminated intravascular coagulation’. There have also been cases of clots in vessels draining blood from the brain.“. We then speak of” cerebral venous thrombosis “(TVC, CVST in English). As of Wednesday evening, the EMA was aware of 7 cases of” disseminated intravascular coagulation “and 18 cases of” cerebral venous thrombosis “, coming mainly from Germany (7) but also from Italy, Norway, Spain, United Kingdom and India. “out of nearly 20 million people vaccinatedThe differences between states (there is only one case reported in the UK, while the vaccine is administered at full rate) could be explained by population profiles.

“We are launching additional examinations to better understand these rare cases, and will conduct targeted observational studies“, adds the director of the EMA. The agency repeated in recent days that cases of blood clots did not seem more frequent among people vaccinated with the product AstraZeneca than in the rest of the population. have heard of serious cases of thromboembolic events with unusual characteristics, such as low blood platelets.