Conditions of Authorisation for Vaxzevria - Last updated June 2023
Updated 22 November 2023
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VAXZEVRIA
COVID-19 Vaccine
Full Marketing Authorisation
Obligation to conduct post-authorisation measures
The Marketing Authorisation Holder shall complete, within the stated timeframe, the below measures:
| Description | Due date |
|---|---|
| In order to further characterise the thrombosis and thrombocytopenia syndrome associated to the vaccine and elucidate its mechanism, the MAH should conduct suitable clinical studies. | 30 June 2024 with annual updates |
| In order to confirm the efficacy and safety of COVID 19 Vaccine AstraZeneca in the elderly and subjects with underlying disease, the MAH should submit the final clinical study report for study D8110C00001. | 31 March 2024 |