European Commission authorises Moderna vaccine against COVID-19
Yesterday, on 6 January 2021, the European Commission granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Moderna, following a positive scientific recommendation issued by consensus by the European Medicines Agency (EMA) and with the endorsement of the Member States. This is the second COVID-19 vaccine authorised by the Commission, after the approval of the BioNTech/Pfizer vaccine on 21 December 2020.
Under EU law, a CMA (which is granted on the basis of less complete data required for a normal marketing authorisation) is a regulatory mechanism to facilitate early access to medicines that fulfil an unmet medical need. CMAs can be granted to new medicines if their benefits clearly outweigh the risk linked to the fact that not all the data are yet available. Once a CMA has been granted, companies must provide further data within certain deadlines.
Moderna submitted on 30 November 2020 an application for a CMA for their vaccine to EMA, which has assessed data on the vaccine’s safety, effectiveness and quality and results from laboratory studies and clinical trials in the context of a rolling review (one of the regulatory tools that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency).
On 25 November 2020, Moderna and the Commission signed a contract for the delivery of 160 million doses of the vaccine between the first and the third quarters of 2021.
For more information, read the Commission’s press release.