12:00 AM
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Nov 05, 2007
 |  BioCentury  |  Strategy

Picking the endpoints

It is not possible to directly demonstrate an HPV vaccine's ability to prevent cervical cancer because it takes decades for infection to cause cancer, and the standard of care is to screen for and excise precancerous lesions. Merck & Co. Inc. and GlaxoSmithKline plc took different approaches to get around this issue.

Given the problem in showing direct clinical efficacy, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) issued recommendations to FDA on efficacy endpoints for HPV vaccines in November 2001.

VRBPAC told FDA that it would be appropriate to use stage 2/3 or worse cervical intra-epithelial neoplasia (CIN 2/3) and cervical adenocarcinoma in situ (AIS) caused by HPV types in a given vaccine as validated surrogates for cervical cancer that can be used to demonstrate efficacy. CIN 2/3 generally occurs between one and five years after HPV infection.

FDA has not yet issued formal guidance for companies developing HPV vaccines.

In their Gardasil trials, MRK (Whitehouse Station, N.J.) and partner Sanofi...

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