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Cervarix Delayed: Setback for GSK is Opportunity for FDA to Create New Model for Adjuvant Approvals

This article was originally published in RPM Report

Executive Summary

GSK's Cervarix HPV vaccine is going to miss another back-to-school vaccination season in the US, giving Merck even more time to cement its lead with Gardasil. The delay surprised Wall Street-but shouldn't have. FDA is exercising caution about the approval of a second HPV vaccine - one containing a new active adjuvant. The final approval will set new standards for the coming wave of adjuvant-enhanced vaccines.

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