What Will Trigger Modification Of COVID-19 Vaccines?
US FDA’s advisory committee members question when it will be clear current vaccines are not providing sufficient protection and express concern about the time it will take to change their composition given the need for clinical data to gain authorization.
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CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time.
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.