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Statement by Commissioner Kyriakides on the review by the European Medicines Agency of the AstraZeneca COVID-19 vaccine

Met dank overgenomen van Europese Commissie (EC), gepubliceerd op vrijdag 23 april 2021.

Following a formal request by the European Commission, the European Medicines Agency has reviewed additional vaccination and epidemiological data submitted by Member States in relation to the AstraZeneca vaccine to give a more precise scientific opinion on the safety profile of the vaccine in the context of the benefits for different age groups and different rates of infection.

This interim assessment from the European Medicines Agency will support national authorities in making decisions on how to best use this vaccine as part of their vaccines portfolio. I welcome that several of our Member States are reflecting this in their decisions to administer the vaccine to their citizens.

It is clear: the overall benefits of the AstraZeneca vaccine in preventing COVID-19 outweigh the risks of very rare and unusual side effects. The AstraZeneca vaccine is an important part of our vaccines portfolio - it is an effective vaccine that protects from severe disease and death, in the EU and globally.

Today I have written to all EU Ministers of Health to inform them about the interim outcome of this assessment and the maximum possible coordination of our approaches, based on science, taking into account the different national situations.

The rollout of vaccinations across the EU is gaining pace by the day. Over the past week, we have seen on average 2.5 million vaccinations per day across the EU. As of today, 24.5% of the adult EU population is vaccinated with one dose and 9.1% fully vaccinated. This is more than twice as high as one month ago. And as we see from the EU vaccine rollout on the ground - the vaccines are saving people.

With four safe and effective vaccines based on different technologies available across the EU, production capacity ramping up and even exceeding expectations from some companies, this quarter will see a fourfold increase in deliveries compared to the first three months of the year. We are on the right track.

The European framework ensures that we have the most rigorous safety procedures in place and a strict safety monitoring of the use of all vaccines in the EU with the European Medicines Agency at the centre.

The basis for safe vaccination campaigns and the EU Vaccines Strategy is pharmacovigilance. The basis for successful vaccination campaigns is citizens' trust.

Trust requires science, clarity and coherence - let's ensure that we provide this to our citizens.

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