To Avoid ‘Booster Fatigue,’ Future COVID-19 Vaccine Doses Should Target Severe Disease
CDC’s ACIP members say goal for now should not be preventing infection. FDA’s Doran Fink notes that the agency will act diligently on EUA of vaccines in children under five once it receives submissions, cites the complexity of reviewing Novavax’s EUA request for its vaccine.
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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.’
But CBER Director Peter Marks reiterated to Senators that EUAs cannot be granted for those children until applications are completed and submitted.