EMA publishes update on rolling review of AstraZeneca’s COVID-19 vaccine

News Category: 3rd party

Date: 30/12/2020

The European Medicines Agency (EMA) has published an update on its assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University which has been progressing over the past weeks. The Agency is currently assessing data on the vaccine as part of a rolling review.

This update was issued following the decision of the UK MHRA to grant a temporary authorisation of supply of this vaccine in the emergency use setting, which is distinct from a marketing authorisation.

According to the EMA, additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation for Europe and this has been requested from the company. Further information from ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in Q1 2021.

Additional background information on the EMA's ongoing evaluation of potential COVID-19 treatments and vaccines can be found on the Agency's website

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