US FDA To Publish Advisory Committee Timeline For COVID-19 Vaccine In Children Under 5
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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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.
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.’
The company announced early data for a combination vaccine against SARS-CoV-2 and influenza, which could provide a revenue opportunity of $2bn.