EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain. The assessment of the vaccine known as Moderna COVID-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline.
The timeframe is truncated as the EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data from laboratory studies and also started assessing data on immunogenicity (how well the vaccine triggers a response against the virus) and safety from an early study.
EMA will now assess the data submitted as part of the formal application for conditional marketing authorisation. The Agency and its scientific committees will continue working on the assessment over the Christmas period. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 12 January, at the latest.
These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds. EMA will communicate on the outcome of its assessment accordingly.
During the review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
In the EU, CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available. CMAs are being used in the context of the COVID-19 pandemic to promptly respond to the public health threat. However, the data must show that the benefits of the medicine or vaccine outweigh any risks. Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm the benefits continue to outweigh the risks.
If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA, post which the European Commission will fast-track its decision-making process with a view to granting a CMA valid in all EU and EEA Member States within days.
As for all medicines, EU authorities continuously collect and review new information on medicines once they are on the market and take action when needed. In line with the EU safety monitoring plan for COVID-19 vaccines, monitoring will take place more frequently and will include activities that apply specifically to COVID-19 vaccines. Companies for example will provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of COVID-19 vaccines after their authorisation.