Update: India’s HPV vaccination project, clinical trial guidelines were violated


April 29, 12:30 PMVaccines ExaminerNorma Erickson

This morning, The Times of India reported Dr. V.M. Katoch, Secretary of the Department of Health Research, admitted that proper guidelines on vaccine administration in his country were “not adhered to in the present case.”

Early this month, India suspended the administration of any HPV vaccines pending the outcome of an investigation into allegations of death, illness and ethical concerns surrounding a demonstration project in two rural Indian provinces.

Guidelines for vaccine administration, prepared by the Drug Controller General of India, clearly state that third phase clinical trials can not be conducted on children until after a similar trial is conducted on adults.

HPV vaccines are currently approved for use in women, ages 9 to 26. It would have been a simple matter for Merck, GlaxoSmithKline, and Path International to follow the established guidelines. They apparently chose to try and avoid compliance with the established guidelines by calling their efforts to vaccinate children a ‘demonstration project,’ instead of a clinical trial.

No one knows why these people decided to vaccinate children between the ages of 10 and 14, when it would have been just as easy to vaccinate women between the ages of 21 and 26. Why were the official guidelines not followed when it would have been so easy to comply?


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.