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: Pandemic COVID-19 Vaccine (Non-Replicating Adenovirus-Vectored Vaccine), Pandemic COVID-19 Vaccine (mRNA Vaccine), Pandemic COVID-19 Vaccine (Recombinant Spike protein) and Pandemic COVID-19 Vaccine, Inactivated guidelines are now all available in the full version with the model protocol for manufacturers.
|
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) revised |
07/09/22 |
15/09/22 |
|
Pandemic COVID-19 Vaccine (Recombinant Spike protein) (full version) |
08/03/22 | 21/03/22 |
| Pandemic COVID-19 Vaccine, Inactivated (full version) | 29/11/22 | 15/12/22 |
