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FDA master protocol for COVID-19 vaccine safety open for public comment

(Patrick Ryan) #1


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.

Weekly OHDSI Digest-12April2021
(Patrick Ryan) #2

Team, thanks to all who provided feedback on this FDA draft protocol in the OHDSI MSTeams chat. Special shout-out to @schuemie and @Daniel_Prieto for their comments. In the interest of full transparency, attached is the feedback response document that @hripcsa submitted to FDA today on behalf of our community. OHDSI comments on FDA COVID19 Vaccination Master Risk Assessment Protocol.pdf (76.3 KB)

For those thirsting for more protocol review opportunities, our friends at FDA have posted yet another document that is open for public comment through 15Apr2021: https://www.bestinitiative.org/wp-content/uploads/2021/04/Assessment-of-C19-Diagnosis-Code-Using-SARS-CoV-2-Test-Results-Study-Draft-Protocol.pdf.

This work should be of particular interest to the phenotype evaluation enthusiasts in the community (looking at you @Juan_Banda @jswerdel @Azza_Shoaibi @Gowtham_Rao @aostropolets @karthik @jon_duke ) as well as everyone who has been developing COVID-related phenotypes for OHDSI network studies (@krfeeney @scottduvall ) or in other related efforts like N3C (@Andrew @Vojtech_Huser). Happy commenting!