Europe – Covid-19 vaccine Vaxzevria : Safety update

Severe allergic reaction will be included in the product information as a known side effect.

A warning on very rare specific blood clot events has been included in the product
information, while further investigations into a possible causal relationship with the vaccine are ongoing.

Vaccinated persons should seek immediate medical attention if symptoms of blood clotting
and/or bleeding occur.

The benefits of Vaxzevria in preventing COVID19 continue to outweigh the risks; and there
are no recommended changes regarding the use of this vaccine.

Safety updates provide the outcomes of the assessment of emerging data since marketing authorisation for COVID-19 vaccines. The assessments are carried out by EMA’s safety committee (Pharmacovigilance Risk Assessment Committee [PRAC]). The safety updates are published regularly at COVID-19 vaccines: authorised.

All published safety updates for Vaxzevria (previously known as COVID-19 Vaccine AstraZeneca) are available at Vaxzevria: safety updates…