Reference:
European Medicines Agency (2021). Assessment report on the annual renewal of the conditional marketing authorisation for Comirnaty (COVID-19 mRNA vaccine). EMA/596333/2021.
Summary:
The European Medicines Agency (EMA) conducted an assessment for the annual renewal of the conditional marketing authorisation (CMA) for Comirnaty, a COVID-19 mRNA vaccine developed by BioNTech. Originally granted on 21 December 2020, the CMA necessitates that the marketing authorisation holder (MAH) submit ongoing study results.The report outlines the progress on specific obligations (SOBs) related to the vaccine’s efficacy, safety, and quality. While several obligations are ongoing, including the need for additional characterisation and quality control data, the overall benefit-risk balance remains positive. The available clinical evidence supports a tolerable safety profile and high vaccine efficacy, particularly in individuals aged 12 and older. The report concludes that the MAH has complied with the requirements, and recommends the renewal of the CMA, with ongoing monitoring and updates to the risk management plan.