COVID-19: latest on evaluation and authorisation of vaccines

MEPs will quiz EMA Executive Director Emer Cooke on the latest developments regarding the evaluation and authorisation of COVID-19 vaccines in the EU.

On Tuesday, Emer Cooke, Executive Director of the European Medicines Agency (EMA) will update Members of the Environment, Public Health and Food Safety (ENVI) Committee on the status of approving COVID-19 vaccines. They will also discuss the EMA’s recent evaluation of the AstraZeneca vaccine.

When: Tuesday 23 March 2021, 10.00-11.00 (indicative timing)

Where: European Parliament in Brussels, room Paul-Henri Spaak (3C050) and videoconference

You can watch the debate live here.

Background

Following positive scientific recommendations, the EMA has authorised four vaccines against COVID-19 for use in the EU (BioNTech-Pfizer, Moderna, AstraZeneca and Johnson & Johnson). Two additional contracts have been concluded that will allow vaccines to be purchased once they have proven to be safe and effective: Sanofi-GSK and CureVac (both under rolling review). Exploratory talks were also concluded with two companies, Novavax and Valneva. The EMA also started a rolling review of the Sputnik V vaccine (which is not part of the EU’s COVID-19 vaccines portfolio).

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), responsible for evaluating safety issues for human medicines, investigated whether the COVID-19 AstraZeneca vaccine can cause thromboembolic events. The results were presented on 18 March 2021, concluding that the benefits of the vaccine still outweigh the risks, despite a possible link to rare blood clots.