States vs FDA: When Can They Go It Alone On COVID Shots, Treatments?
Two GOP governors are talking about using COVID products in ways not authorized by the US government. But the different paths they are taking could lead to different enforcement approaches by the feds – as well as different political outcomes for the governors.
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Florida Versus US FDA ... Again
The very public attempt by the state of Florida to question FDA’s decision on COVID monoclonal antibodies is the latest example of how the politics of COVID is roiling the agency’s reputation. But is it really so different than Florida’s pre-pandemic plans to import drugs from Canada?
CDC’s Walensky Suggests Higher Bar May Be Needed For Fourth COVID Vaccine Shots
Pfizer and Moderna have both indicated a fourth mRNA COVID vaccine may be needed. Companies may need to show waning protection against severe disease first.
Full Approval Without Some Benefits: FDA Cautions Against Off-Label Use Of Pfizer’s COVID-19 Vaccine For Children, Boosters
Unique nature of COVID-19 vaccine distribution in the US rules out off-label prescribing for Pfizer and BioNTech’s fully approved shot, and FDA isn’t on board with it for children under 12 and boosters yet. The need to better understand dosing and myocarditis risk in young children appears to be a key motivating factor for discouraging unauthorized and unapproved use. FDA handed Pfizer six post-market requirements related to better characterizing the myocarditis risk with its vaccine and one post-market commitment.