Oral polio vaccine neurovirulence tests

Executive Summary

Lederle files petition with FDA on June 7 seeking a stay of action on the effective date of the agency's recently published rule on neurovirulence testing standards for oral polio vaccine. On the same day, Lederle also filed objections and request for a hearing on the OPV test standards. FDA's OPV final rule, published May 8, was essentially a compromise measure that permitted use of both WHO test standards, sought by Connaught, and the U.S. standard used by Lederle for the past 25 years ("The Pink Sheet" May 20, T&G-6). Lederle maintains that "any change in safety testing for [OPV] must be justified by a conclusive demonstration that the new test is at least as good as the old".