The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021. The availability of the list of tests, which have been adopted by the full OCABR network, will help OMCLs and manufacturers prepare for the launch of these anticipated vaccines in a smooth and timely manner.
The new OCABR Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored COVID-19 Vaccine), in force from 1 May 2021, is also available. It includes the list of tests to be performed by OMCLs for OCABR and the model protocol for manufacturers. This new guideline combines and replaces the formerly separate list of tests found in the Guidelines Pandemic COVID-19 Vaccine (Non-replicating Chimpanzee Adenovirus-vectored COVID-19 Vaccine) and Pandemic COVID-19 Vaccine (Non-replicating Human Adenovirus-vectored COVID-19 Vaccine), which entered into force on 12 November 2020.
The guidelines are for use by OMCLs and manufacturers to ensure a codified and smooth process for timely release of these important vaccines.
Both guidelines are available for download from the European Directorate for the Quality of Medicines & HealthCare (EDQM) web page on OCABR activities related to COVID-19 vaccines:
- Guideline for Pandemic COVID-19 Vaccine (Non-Replicating Adenovirus-Vectored COVID-19 Vaccine) (full version)
- Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein) (section 2 only)