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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: The guidelines have been prepared based on current knowledge. Once the relevant marketing authorisations have been approved they will be reviewed and updated accordingly including addition of a model protocol for the manufacturer’s data submission.

Document title

Last web update

In force from

Pandemic COVID-19 Vaccine (Non-Replicating Chimpanzee Adenovirus-Vectored Vaccine)

06/11/20

12/11/20

Pandemic COVID-19 Vaccine (Non-Replicating Human Adenovirus-Vectored Vaccine)

06/11/20

12/11/20

Pandemic COVID-19 Vaccine (mRNA Vaccine)

06/11/20

12/11/20

 

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.

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