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US FDA To Publish Advisory Committee Timeline For COVID-19 Vaccine In Children Under 5

Executive Summary

But CBER Director Peter Marks reiterated to Senators that EUAs cannot be granted for those children until applications are completed and submitted.

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COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review

Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.

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.’

Straggler Novavax Still Hopes To Hit Paydirt With Combo Vaccine

The company announced early data for a combination vaccine against SARS-CoV-2 and influenza, which could provide a revenue opportunity of $2bn.

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