COVID Vaccines: Is Expanded Access A Better Option Than Emergency Use Authorization?
Executive Summary
Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.
You may also be interested in...
Expanded Access With COVID Therapeutics Were ‘Worst-Case Scenario’ For Informed Consent
High-profile programs, such as convalescent plasma, also created public confusion about role of preapproval access and highlighted the importance of prospectively planning for reliable data collection, experts said at the DIA global annual meeting.
Moderna’s Stronger Vaccine AdComm Vote Indicative Of Second Mover Advantage, Not Data Profile
Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s phrasing of voting question complicated meeting but resulted in minimal harm.
‘The Gruber Moment’: How CBER Got The Answers It Wanted On COVID Vaccine Guidance
As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.