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OCABR activities related to COVID-19 vaccines

  • IDENTIFY AN OMCL FOR OCABR: To help manufacturers identify OMCLs for the conduct of OCABR a list of OMCLs with capabilities relevant for OCABR of COVID-19 vaccines has been established and is available to manufacturers on request at BatchRelease@edqm.eu.
  • FACILITATING TIMELY TEST TRANSFER: Recommendations for early transfer to OMCLs of methods for potential EU OCABR tests of COVID-19 vaccines candidates to comply with the accelerated vaccine development timelines; available to manufacturers on request at BatchRelease@edqm.eu. Elements of this recommendation are also relevant for blood derived medicinal products.
  • PRODUCT SPECIFIC GUIDELINES: NEW: Pandemic COVID-19 Vaccine (Non-Replicating Adenovirus-Vectored Vaccine) and Pandemic COVID-19 Vaccine (mRNA Vaccine) guidelines are available in the full version and include an update with the model protocol for manufacturers. A NEW Pandemic COVID-19 Vaccine (Recombinant Spike protein) guideline containing section 2 only is also available. It was prepared based on knowledge available at the time of drafting. It will be updated accordingly including addition of a model protocol for the manufacturer’s data submission, in line with the relevant approved marketing authorisations when available.

Document title

Last web update

In force from

Pandemic COVID-19 Vaccine (Non-Replicating Adenovirus-Vectored Vaccine) (full version)

20/04/21 01/05/21

Pandemic COVID-19 Vaccine (mRNA Vaccine) (full version)

06/04/21

01/05/21

Pandemic COVID-19 Vaccine (Recombinant Spike protein) (section 2 only)

20/04/21 20/04/21

 

The availability of the ‘section 2 only’ guidelines, with the list of tests to be performed by OMCLs for OCABR, at an early stage helps to anticipate the launch of the vaccines and allows OMCLs and manufacturers to take the necessary steps for OCABR thus preventing delays in availability while still ensuring their quality and safety. As soon as possible full guidelines including model protocols are adopted by the network to provide a codified framework for ongoing OCABR.

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