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December 23 2009

Efficacy Data and HPV Vaccination Studies—Reply

JAMA. 2009;302(24):2658-2660. doi:10.1001/jama.2009.1884

In Reply: In response to Drs Baylor and Wharton, it appears that the sentence in my Editorial referring to the time the clinically important end points used in the HPV vaccine trials were reported can be misunderstood. To clarify, there is broad agreement that the effect of the vaccine on cervical cancer cannot be measured directly and must be calculated indirectly through surrogate markers—in this case CIN 2/3 or AIS. As Baylor and Wharton state, data on CIN 2/3 were available and presented at meetings and used as a basis for the FDA approval in June 20061 and the recommendation by CDC ACIP shortly thereafter.2

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