‘The Gruber Moment’: How CBER Got The Answers It Wanted On COVID Vaccine Guidance

12 Nov 2020

• By Kate Rawson

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.

US FDA's CBER's Office of Vaccine Research & Review Director Marion Gruber presents during the 22 October VRBPAC meeting. — CBER's Office of Vaccine Research & Review Director Marion Gruber presents during the 22 October VRBPAC meeting. • Source: Screenshot

The senior US FDA official at an advisory committee meeting can choose to adopt very different tactics in how they engage in the discussion, depending on the situation.

Sometimes, an office director may sit back and say nothing during an eight-hour meeting and limit their interaction to passing...