EMA to undertake a review of data as to the AstraZeneca vaccine’s efficacy in preventing COVID-19 disease

15 April 2021

The European Medicines Agency (EMA) is undertaking a review of vaccination data of the COVID-19 vaccine from AstraZeneca. The review will include infection rates, hospitalisations, morbidity and mortality. The EMA will also prepare a recommendation for those who have received the first dose of the vaccine.

The EMA is starting a review of vaccination data and data on disease epidemiology in regard to the vaccine from AstraZeneca. The review will look at infection rates, hospitalisations, morbidity and mortality insights, etc. and is made at the request of the EU’s Commissioner for Health and Food Safety following a meeting of EU Health Ministers.

The review by the EMA is to guide the EU countries in their decisions on whether or not to use the vaccine in the COVID-19 vaccination programmes of the individual countries. 

In Denmark, this decision is made by the Danish Health Authority based on a health-scientific assessment of whether the vaccine from AstraZeneca and other authorised vaccines are to be deployed in Denmark. The assessment includes, among other things, infection rates and the availability of other vaccines in Denmark.

The EMA considers that the overall benefits of the AstraZeneca vaccine in terms of prevention of COVID-19 disease continue to outweigh the risks in the form of known and possible side effects.

EMA’s press release: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets.

News from the Danish Health Authority:  

Denmark continues its vaccine rollout without the COVID-19 vaccine from AstraZeneca