From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots
Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.
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Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
Patient confidentiality and trial blinding precluded a Janssen official from sharing specifics about the safety event that led to a study enrollment pause, but Advisory Committee on Immunization Practices representatives say the lack of detailed, publicly disclosed information is not helping vaccine confidence.