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With Pfizer EUA For 5-11 And Moderna Delay For Adolescents, US FDA Walks Myocarditis Tightrope

Executive Summary

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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Moderna’s Vaccine Gets Panel Nod In Adolescents, Older Children; Committee Already Eyes Booster

US FDA advisory committee members debate how a third dose, or booster, of the COVID vaccine should fit into the mix of an EUA expansion for the 12-17 and 6-11 groups; Moderna expects to have immunogenicity and safety data on booster doses in both of age groups by mid-July.

Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says

‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.

Moderna COVID Vaccine EUA For Kids Younger Than Six Will Be Big Test For FDA Efficacy Threshold

Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’

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