Coronavirus: EMA receives first two applications for conditional marketing authorisation of COVID-19 vaccines

date: 01/12/2020

The European Medicines Agency (EMA) received applications for a conditional marketing authorisation (MA) for Pfizer/BioNTech's candidate vaccine and Moderna's candidate vaccine. The evaluation of the candidate vaccines will be performed under accelerated assessment. An evaluation on the marketing authorisation could be issued within weeks, depending on whether the submitted data are sufficiently robust and complete to prove the quality, safety and effectiveness of the vaccines.

The accelerated assessment is only possible because the EMA has already reviewed the available data on these vaccines during a rolling review.

The EMA will now assess the data submitted as part of the formal application for a conditional marketing authorisation. The EMA and its scientific committees will continue working on the evaluation over the Christmas period. If the data submitted are robust enough to prove the quality, safety and effectiveness of the vaccines, EMA’s scientific Committee for Medicinal Products for Human Use (CHMP) will complete its evaluation on the Pfizer/BioNTech and Moderna vaccines at the latest during an extraordinary meeting scheduled on respectively 29 December 2020 and 12 January 2021. These timelines are based on the type of data assessed so far during the rolling review and may be subject to change as evaluations proceed.  

During the evaluation and throughout the pandemic, the EMA and its scientific committees are supported by the COVID-19 EMA pandemic Task Force (COVID-ETF), which brings together experts from across the European medicines regulatory network (of which the FAMHP is a member) in order to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

What could be the next steps?
If the EMA concludes that the benefits of the vaccines outweigh their risks in the protection against COVID‑19, the agency will recommend granting a conditional marketing authorisation. The European Commission will then fast-track its decision-making process by granting a conditional marketing authorisation valid in all EU and EEA members within days.

As for all medicines, EU authorities continuously collect and review new information on medicines once marketed 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. For example, companies will provide monthly safety reports in addition to the regular updates required by the legislation and they will conduct studies to monitor the safety and effectiveness of COVID-19 vaccines once authorised.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.

Last updated on 09/12/2020