The latest safety data for this vaccine are in line with the known benefit-risk profile; the
outcomes of the related assessments are presented in this update. Swelling of the vaccinated limb usually recovers by itself.
The benefits of Comirnaty 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 Comirnaty are available at Comirnaty safety updates.
This safety update follows the last update of 4 March 2021…