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US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’

 
• By Sarah Karlin-Smith

Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.

spikevax and comirnaty
FDA authorized both Pfizer’s and Moderna’s COVID-19 vaccines for infants, toddlers and preschoolers on 17 June. • Source: Shutterstock

The US Food and Drug Administration’s authorization materials for Pfizer Inc./BioNTech SE and Moderna, Inc.’s COVID-19 vaccines in the youngest Americans includes one noticeable difference between the two products – while Moderna’s vaccine efficacy data for young children is highlighted, Pfizer’s more premature data is missing.

The difference reflects a higher level of confidence FDA said it has in the available Moderna data.

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BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

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