Controversy halts HPV vax trial in India

Human papillomavirus infection is the cause of nearly all cases of cervical cancer, and so immunizing young women before they are exposed to the virus could save a great many lives. So, the idea of a large scale clinical trial of an HPV vaccine in India seems like a valid idea, based on the country's supposed huge cervical cancer healthcare burden. Not so--according to a paper published in the Journal of the Royal Society of Medicine, the epidemiology behind the study is flawed and the trial is currently the subject of an investigation by the Indian government.

The trial was under the auspices of PATH, an international health charity, and included over 23,000 girls in the Indian states of Gujarat and Andhra Pradesh. The charity had claimed that "in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide." However, according to the study, led by Allyson Pollock of Barts and The London Medical School, the cancer surveillance, registration and monitoring in India in general, particularly in the Gujarat and Andhra Pradesh regions, were incomplete, so that it would be impossible to tell whether the vaccine would be successful in preventing the disease.

The figures that do exist for India show that there were only 22 cases of cervical cancer per 100,000 in 2004/2005 in india, falling from 43 cases per 100,000 in 1982/1983--this is around half the rate in countries like Brazil and Zimbabwe.

"This trial has clearly raised serious concerns for the people and government of India," says Pollock. "We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program."

India does have major health burdens, for example in malaria and other infectious diseases, maternal anemia and malnutrition, and so the use of an expensive HPV vaccine, which is one of the more expensive vaccines on the market, for a health issue with a lower impact would seem to be a flawed use of limited financial resources.

- read the press release
- see the paper

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