Latest From Brenda Sandburg
Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.
NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead.
Agency is removing warning contraindicating use of statins during pregnancy; the move comes after FDA has permitted COVID-19 vaccination of pregnant women and amidst push for their enrollment in clinical trials.
FDA’s Robert Temple says he is gratified by the way companies have implemented the agency’s guidance on IND safety reporting. Merck, AbbVie and Janssen representatives discuss issues with unblinding data and the value of an aggregate analysis at DIA’s annual meeting.
ACIP will discuss possible boosters for immunocompromised people next week. Pfizer’s head of vaccine R&D and BioNTech co-founder and CEO discuss whether neutralizing antibodies are necessary for protection against SARS-CoV-2, indication in children, and the low and high points of their collaboration at Stat summit.
Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.