Italian Medicines Agency Agenzia Italiana del Farmaco

EMA publishes safety updates for the COVID-19 vaccines Comirnaty, Moderna and AstraZeneca - EMA publishes safety updates for the COVID-19 vaccines Comirnaty, Moderna and AstraZeneca

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EMA publishes safety updates for the COVID-19 vaccines Comirnaty, Moderna and AstraZeneca

EMA continues the publication of safety updates for COVID-19 vaccines, the third report for Comirnaty and Moderna and the first for the AstraZeneca vaccine, Vaxzevria. The safety updates summarise the data that have become available since the vaccine's authorisation. They also indicate whether any safety information requires further investigation.

For Vaxzevria, severe allergic reactions have been identified as new side effects. In addition, a warning on specific rare events associated with blood cloths has been inserted. Evaluation on such events in still ongoing to establish a possible causal role of the vaccine. Vaccinated persons should be advised of the need to seek immediate medical attention if they develop symptoms related to blood clots or bleeding.

For Comirnaty and Moderna, the latest safety data for this vaccine are in line with the known benefit-risk profile.

The benefits of Vaxzevria, Comirnaty and Moderna in preventing COVID-19 continue to outweigh the risks and there are no recommended changes regarding the use of these vaccines.

The safety updates are available in "Related Link"


Published on: 30 March 2021

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