(291) Knowledge Build-Up on The Safety of EMA Approved COVID-19 Vaccines: An Overview

Publication Number: 1336

Background: Since the start of the COVID-19 pandemic, regulatory authorities have been actively working on acquiring knowledge about the safety of COVID-19 vaccines, for instance based on spontaneous reporting systems and post-marketing studies. Based on the acquired knowledge, the safety profile is then further characterized, and recommendations are made for the amendment of the product information (PI). Mapping the knowledge build-up on the safety of COVID-19 vaccines and the time frame in which regulatory authorities have taken safety concerns into consideration is important from the viewpoint of providing timely information and transparency for different stakeholders.

Objectives: Describing both the safety concerns of COVID-19 vaccines for which a PI update was recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and safety concerns that were considered by the PRAC without being labeled in the PI. Additionally, this study also had the objective to map the time frame in which the safety concerns were considered by the PRAC.

Methods: The safety concerns were extracted from the publicly available safety updates on the EMA website, published between January 1, 2021 and December 31, 2021, for the following centrally authorized COVID-19 vaccines: Comirnaty®, Spikevax®, Vaxzevria® and COVID-19 Vaccine Janssen®. The month of publication of the safety updates was used to map the time frame in which the safety concerns had been considered by the PRAC. Data-analysis was performed using descriptive statistics.

Results: The safety concerns that were recommended to be added to the PI of the COVID-19 vaccines (N=36) mostly involved nervous system disorders (N=6), immune system disorders (N=5), skin and subcutaneous tissue disorders (N=5) and general disorders and administration site conditions (N=5). Examples include Thrombosis with thrombocytopenia syndrome (TTS) for the AstraZeneca® and Janssen vaccine and myocarditis/pericarditis for the Pfizer® and Moderna® vaccines. On the other hand, immune system disorders (N=2), cardiac disorders (N=2), renal and urinary disorders (N=2) and vascular disorders (N=2) were mostly involved for unlabeled safety concerns that had been considered - but not (yet) been added to the PI - by the PRAC in 2021 (N=13). Examples include multisystem inflammatory syndrome (MIS) and menstrual disorders. The timelines of the knowledge build-up on the safety of the vaccines were graphically represented.

Conclusions: This overview facilitates the identification of differences between labeled and unlabeled safety issues in the PI of COVID-19 vaccines and the timing of label change recommendations for the various vaccines.