News from the Danish Medicines Agency
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EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine
| 22 December 2020 |
The expert committee of the European Medicines Agency, EMA, which is presently assessing Moderna’s application for conditional marketing authorisation of their COVID-19 vaccine in the EU has scheduled a meeting on 6 January at which it may recommend authorisation to the European Commission. If so, the European Commission may formally authorise the vaccine within a few days.
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EMA starts rolling review of corona vaccine from Janssen
| 02 December 2020 |
The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.
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EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines
| 02 December 2020 |
The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.