Presented to FDA 10/22/2020
Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation
CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness
NOTE:
– page 2 – TITLE
– slide 8 – POST licensure safety surveillance – this way they do not have to report pre-licensure and this is why no licensed products have been approved
– Slide 11 – BEST System (no publicly available data to this point)
– page 16 – CMS data and near real time efforts
– page 17 – Adverse events outcomes being monitored for
– page 23-24 – Govt agencies monitoring safety and weekly meetings – they knew
