Moderna’s COVID-19 Second Booster Authorization Largely Thanks To Pfizer/BioNTech Data
Safety and effectiveness of an mRNA-1273 second booster dose was inferred in large part by extrapolation from reported evidence following use of the Pfizer/BioNTech COVID-19 vaccine in individuals 60 years and older in Israel, FDA review memos show.
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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.’