The Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines.
The update includes a revision of the list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for Official Control Authority Batch Release (OCABR), and a note in the protocol section to address the possibility of having vaccines against more than one strain.
The updated version will be in force from 15 September 2022.
The guideline is for use by OMCLs and manufacturers to ensure a codified and smooth process for timely release of these important vaccines.
The guideline is available for download from the European Directorate for the Quality of Medicines & HealthCare (EDQM) web page on OCABR activities related to COVID-19 vaccines: