With Pfizer EUA For 5-11 And Moderna Delay For Adolescents, US FDA Walks Myocarditis Tightrope
COVID vaccine safety concerns from international analyses will force sponsors and FDA to again confront the challenge of how to make bad news for one shot not turn into bad news for all.
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Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.
The company sees better times ahead for mRNA-1273, with supply contracts raising guidance for 2022, not to mention progress in its non-COVID-19 pipeline.
11 Going On 12: CDC Panel Pays Special Attention To Kids Caught In Middle Of Pfizer/BioNTech Vaccine Dose Increase
Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.