The OCABR guidelines outline the tests that will need to be performed by the Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches.
The new guidelines, released today, cover non-replicating chimpanzee adenovirus-vectored vaccines (as for AstraZeneca’s vaccine candidate); non-replicating human adenovirus-vectored vaccines (as for Johnson & Johnson’s candidate); and mRNA vaccines (as for Pfizer/BioNTech).
“These [guidelines] are expected to address the vaccines currently predicted to arrive first on the European market,” notes the EDQM. “Additional guidelines are under development to address other vaccine types which are under development for the COVID-19 pandemic and are intended for the European market (e.g. recombinant protein-based vaccines).
“Independent control of each batch of COVID-19 vaccine, before it reaches the patient, is an important part of the EU regulatory network strategy to ensure the availability of vaccines that meet the appropriate quality requirements and to protect public health.”
The European Commission has agreed COVID-19 vaccine deals with Pfizer/BioNTech (300 million doses); Sanofi/GSK (300 million doses); AstraZeneca (300 million doses); and Janssen (up to 400 million doses). It has also concluded ‘successful exploratory talks’ with CureVac and Moderna.
No COVID-19 vaccines have yet obtained marketing authorisation in the EU: although the EMA has started a rolling review for candidates (including AstraZeneca and Pfizer’s candidates).
“The guidelines have been prepared based on current knowledge,” notes the EDQM.
“Once the relevant marketing authorisations have been approved, they will be reviewed and updated accordingly, including the addition of a model protocol for the manufacturer’s data submission.
"The availability of these guidelines at an early stage will help anticipate the launch of the first vaccines and allow OMCLs and manufacturers to take the necessary steps to prepare for OCABR, thus preventing delays in availability while still ensuring their quality and safety.”
The guidelines can be found here.
