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

 
• By Sue Sutter

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.’

Comfort zone
The Moderna pediatric EUA request will test the FDA and VRBPAC's comfort zone on vaccine efficacy. • Source: Shutterstock

Moderna, Inc.’s emergency use authorization request for its COVID-19 vaccine in children younger than 6 years could be the first major test of the US Food and Drug Administration’s – and its external advisors’ – comfort with a vaccine that falls at or below the 50% clinical efficacy threshold.

On 28 April, Moderna announced submission of an EUA request for mRNA-1273 in two groups of children: ages 6 months-<2 years, and 2-<6 years

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