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COVID-19 vaccines: making sure they are safe

All medicines, including vaccines, are closely monitored in the EU after they are authorised and put on the market.
Statistically, side effects are rare or very rare. The safety and effectiveness of authorised COVID-19 vaccines will be rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.

The role of the European Medicines Agency

Europe already has a robust system to ensure long-term vaccine safety, and the European Medicines Agency has a solid track record in keeping Europe safe.

 

Constant monitoring

Europe-wide database

Global protection
The European Medicines Agency (EMA) constantly monitors reports of any side effects after a vaccine is used.

The EMA has a Europe-wide database of reports from patients, health professionals and researchers.

 

The database allows EMA experts to quickly identify and act on potential risks while medicines are in use.

The EMA regularly exchanges information with the World Health Organization and with medicines regulatory agencies of other countries, to keep track of issues that have arisen in other parts of the world.

 

This increases the level of medicines’ safety in Europe even more.

EU’s medicines monitoring system

Large-scale monitoring

Exceptionally high numbers of people are expected to receive the vaccines at the same time. The European Medicines Agency has mobilised extra resources to carry out its regular monitoring activities more rapidly and on a bigger scale.

Follow-up studies and tests

A conditional authorisation may be granted for a medicine or vaccine to be made available in emergency situations such as COVID-19.

Manufacturers commit to do more studies and tests after the vaccine is launched.

Frequent safety reports

Usually, vaccine manufacturers must send a safety report to the European Medicines Agency every six months.

For COVID-19 vaccines, the safety report must be sent every month.

Maximum transparency

The European Medicines Agency ensures maximum transparency in its work on COVID-19 vaccines.

Once a vaccine is approved, the EMA will publish additional regular updates summarising safety reports.

Documents

 

10 DECEMBER 2020
Factsheet: COVID-19 vaccines: Making sure they are safe
English
(5.95 KB - HTML)
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