Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people. The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of […]
Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). The US FDA and CDC […]
EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
EMA confirms overall benefit-risk remains positive EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc […]
Commission strengthens transparency and authorisation mechanism for exports of COVID-19 vaccines
The European Commission has introduced the principles of reciprocity and proportionality as new criteria to be considered for authorising exports under the transparency and authorisation mechanism for COVID-19 vaccine exports. This system has significantly improved the transparency of exports. Nevertheless, the objective to ensure timely access to COVID-19 vaccines for EU citizens is still not […]
COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events
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 […]
European Commission authorises fourth vaccine against COVID-19: Janssen
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the fourth COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and […]
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety […]
MEPs urge EU countries to be transparent about their COVID-19 vaccine supplies
Parliament’s Environment, Public Health and Food Safety Committee calls for a fact-based approach to the EU vaccines rollout to avoid disinformation. In order to respond to European citizens’ growing concerns, data on the number of vaccine doses supplied and on the vaccination schedules for each country must be transparent and provided on a monthly basis […]
European Commission authorises the AstraZeneca vaccine against COVID-19
The European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by AstraZeneca, the third COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed […]