EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine
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.
The EMA’s expert committee, the Committee for Medicinal Products for Human Use (CHMP), is evaluating data from several vaccine manufacturers in connection with their applications for conditional marketing authorisation of their respective vaccine candidates in the EU and thus Denmark.
The assessments are carried out by independent experts who thoroughly review the comprehensive material, including data from phase 3 clinical trials involving some 30,000 trial subjects.
The progress of this procedure depends on the quality of the data submitted to the EMA and on the availability of any additional information the EMA might request to receive from the companies during their evaluations.
A recommendation for a conditional marketing authorisation is likely to be made on 6 January
Only a few days ago, the EMA announced that the experts will hold a meeting on 21 December to discuss a possible recommendation to the European Commission for the granting of a conditional marketing authorisation for BioNTech/Pfizer’s vaccine. Now the agency is also ready to discuss the recommendation of yet another vaccine candidate, namely that of Moderna.
The experts of the EMA will only recommend the European Commission to grant a conditional marketing authorisation if there is sufficient documentation on the vaccine’s quality, safety and efficacy to decide if the benefits of the vaccine in regard to its effect on COVID-19 outweigh the risks in regard to any theoretical side effects.
Conditional marketing authorisation is expected already on 8 January 2021
If the EMA/CHMP recommends the granting of a marketing authorisation for a vaccine, the European Commission will fast track its decision so that a marketing authorisation applicable in all EU and EEA countries can be granted within a few days.
If a conditional marketing authorisation is granted, a lot of extra material will be published along with it to ensure a subsequent informed debate on the vaccine.
This will include:
- Product information and package leaflet with detailed instructions for safe use,
- A plan for safety monitoring of the vaccine,
- Background information on manufacturing and batch controls for vaccines and conditions for storage,
- An investigation plan for use in children,
- The legally binding post-approval obligations (i.e. conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.
A conditional marketing authorisation ensures that COVID-19 vaccines meet high EU standards. It will be valid in all EU member states at the same time.
Further reading:
EMA’s press release:
News on the website of the Danish Medicines Agency 1 December (2 December in English): EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines
Danish Medicines Agency’s COVID-19 theme page. (in Danish only)