Europe Confirms the Comirnaty Vaccine's Benefit-Risk Profile

The European Medicines Agency (EMA) announced on March 4, 2021, the latest safety data for the Comirnaty Vaccine (Pfizer-BioNTech) are in line with the known benefit-risk profile, and the outcomes of the related assessments are presented in this update.

The benefits of Comirnaty in preventing COVID19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine, says the EMA.

Safety updates provide the outcomes of the assessment of emerging data since marketing authorization for COVID-19 vaccines. Diarrhea and vomiting after vaccination have been identified as new side effects.

The EMA’s Pharmacovigilance Risk Assessment Committee carries out the assessments based on all available data.

Comirnaty was authorized in the European Union on December 21, 2020, for use in people aged 16 years and older to prevent the development of COVID-19 when infected with the coronavirus SARS-CoV-2. Comirnaty contains a molecule called mRNA, which the body uses to produce the SARS-CoV-2 spike protein temporarily.