Our friends at FDA/CBER have posted a draft master protocol for their COVID-19 vaccine safety surveillance efforts.
The protocol is open for public comment until Thursday, 8 April 2021. We encourage the community to review the protocol and provide your feedback. As with prior FDA draft documents, @hripcsa @msuchard and I will be collating feedback from those in the OHDSI workgroups that are currently working on COVID-19 vaccines methods work (in OHDSI MSTeams; PLE/PLP workgroup team --> EUMAEUS channel), and will submit a collective response to FDA on behalf of the community.
Thanks in advance for your collaboration.