COVID-19
COVID-19 vaccines: Article 5(3) reviews
Table of contents
The European Medicines Agency (EMA) may review COVID-19 vaccines under Article 5(3) of the Regulation establishing EMA (Regulation (EC) No 726/2004).
This is intended to support national decision-making on the use of these vaccines.
EMA's CHMP is currently not reviewing data on any vaccine under Article 5(3) of Regulation (EC) No 726/2004.
EMA's CHMP has reviewed data on the following vaccines, under Article 5(3) of Regulation (EC) No 726/2004:
| Vaccine | Key milestones | More information |
|---|---|---|
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Start of review: 14/04/2021 Interim opinion: 23/04/2021 | Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets AstraZeneca’s COVID-19 vaccine: benefits and risks in context Article 5(3) opinions: Use of Vaxzevria to prevent COVID-19 |
For more information, see: