As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process. Moderna CEO Stéphane Bancel recently outlined his new timeline, looking to nail down interim efficacy and safety data by the second half of next month that could allow them to hunt an EUA — provided the data work. And Pfizer CEO Albert Bourla has just shifted his stance on their EUA timing to a point just after the looming election, underscoring how the scene has continued to change in light of a heated partisan debate between a president who has repeatedly promised a quick OK and his political opponent, who’s waiting for a thumbs up from experts like NIAID chief Anthony Fauci before offering his own support.