CONNAUGHT OPOL LIVE OPV: FDA FINDS SEVEN OF 12 CLINICALS CONFORM
CONNAUGHT OPOL LIVE OPV: FDA FINDS SEVEN OF 12 CLINICALS CONFORM to federal requirements for vaccine licensure under 21 CFR 630.11, FDA Office of Vaccines Research & Review Senior Staff Fellow Judy Beeler, MD, said during discussion at a Nov. 18 meeting of FDA's Vaccines & Related Biological Products Advisory Committee. Beeler said the PLA committee for Toronto-based Connaught, Ltd.'s trivalent live oral polio vaccine reviewed the immunogenicity data derived from 12 clinical trials. FDA analysis was based on determining seroconversion rates to find a four-fold or greater rise in type-specific neutralizing antibody, Beeler noted.
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