From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots
Executive Summary
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.
You may also be interested in...
Anaphylaxis Is Pharmacovigilance Focus As Moderna Vaccine Distribution Begins
No reactions have been observed with Moderna’s COVID vaccine, but none were seen in Pfizer’s trial either; proprietary components may complicate effort to find cause of anaphylactic reactions, but FDA and CDC officials express confidence in surveillance systems, and CBER’s Peter Marks suggests polyethylene glycol may be possible culprit.
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.
Lack Of Details On J&J COVID Vaccine Trial Safety Pause Raises ACIP Concerns About Transparency
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.