Pertussis Vaccine redefined

Executive Summary

FDA is revising definition of pertussis vaccines to clarify that current licensure standards of production, reference, potency and toxicity are not applicable to acellular pertussis vaccines. FDA notes that it "is not proposing regulations for additional standards for the new acellular vaccines at this time." The final rule is effective as of publication in the Dec. 4 Federal Register. FDA notes that "clinical data and manufacturing specifications in [pending acellular] PLAs may support licensure in the near future".