Coronavirus: EMA receives application for conditional marketing authorisation for AstraZeneca vaccine

date: 12/01/2021

The European Medicines Agency (EMA) received an application for a conditional marketing authorisation (MA) for AstraZeneca's candidate vaccine. The evaluation of the candidate vaccines will be performed under accelerated assessment. An evaluation on the marketing authorisation will be issued on 29 January 2021, 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.

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.

How does the AstraZeneca vaccine work?
The vaccine developed by AstraZeneca and the University of Oxford is a viral vector vaccine.
Viral vector vaccines use a known virus that does not cause disease in humans. This can be an innocuous virus or a live attenuated virus used in another vaccine. In AstraZeneca's case, it’s the adenovirus. An antigen (spike protein) or the genetic code of an antigen is added to this viral vector. Some viral vector vaccines can replicate in the host cell (replicating viral vector vaccines), others cannot (non-replicating viral vector vaccines), depending on the changes made to the vector genome. AstraZeneca's vaccine is a non-replicating viral vector vaccine.

Last updated on 15/01/2021