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.’

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

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