S.A.N.E. Vax requests temporary suspension of Gardasil sales as cervical cancer preventive

October 09, 2017

Erickson further informed the Commissioner that the NCI knew the only reliable HPV genotyping method is a "PCR system with short target sequences." However, such a reliable HPV genotyping method was never used to 'determine the associated HPV type' in the clinical trials for evaluation of the efficacy of Gardasil?? to prevent type-specific HPV infections. Obviously, any data collected using unreliable methods cannot be used to reliably evaluate the efficacy of any drugs or vaccines, said Erickson.

Based on their recent research, S.A.N.E. Vax, Inc. requested a temporary suspension of the sales and marketing of Gardasil?? as a cervical cancer preventive, until such time as the efficacy of the vaccine is properly re-evaluated using the true endpoint for cervical cancer prevention, and a reliable HPV genotyping method for detection of type-specific HPV infections.

In view of the pending review of Merck's new application for expanded use of Gardasil?? as a vaccine to prevent "anal dysplasia and cancer" in both men and women, Erickson also sent a letter to all members of the VRBPAC, requesting the Committee to use appropriate primary endpoint and reliable HPV genotyping methods to evaluate the efficacy of the vaccine, based on the same scientific arguments put forth in the letter addressed to the FDA Commissioner.

Source S.A.N.E. Vax, Inc.