Pink Sheet Podcast: NIH Director Leaving, Federal COVID-19 Messaging Issues, FDA Assessment Costs
Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.
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Many of US FDA's outside vaccine advisors wanted to wait for more data before widespread inoculations of kids 5-11, but felt some high-risk populations should get access to vaccine right away. They urged CDC to provide additional guidance on which children should be targeted.
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
Overall benefit still favorable when there could be excess hospitalizations due to vaccine-related myocarditis because of ‘the different clinical implications of hospitalization for COVID-19,’ FDA concludes ahead of the advisory committee.