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This is an archive article published on April 18, 2010

Central panel to probe cervical cancer vaccine trial

A three-member committee has been formed to look into clinical trials of the human papillovirus vaccine meant for the treatment of cervical cancer.

Human papillovirus vaccine was stopped after 4 deaths occurred in Andhra Pradesh

A three-member committee has been formed to look into clinical trials of the human papillovirus vaccine meant for the treatment of cervical cancer. The drug was stopped by the Union Health Ministry after four deaths occurred in Andhra Pradesh. Altogether 24,705 patients,primarily from tribal areas of two districts in AP and Gujarat had been administered doses of the vaccine.

Dr B R Solanki,Chief District Medical Officer for Vadodara,said all the 10,686 girls,who were vaccinated over a span of three months,are safe. “There were no deaths or major illnesses reported from any of these areas in Vadodara. However,after administering the drug,vomiting and nausea were reported,which was taken care of,” he said.

Dr Solanki said that several NGOs in Vadodara that work in the tribal areas of the district—Naswadi and Kawant— had conducted the trials.

But according to Jan Swasthya Abhiyan—an inter-state collective formed out of women’s and health safety organisations—licensing of the vaccines,Gardasil and Cervarix,was done on the basis of sketchy studies. These were not close to ground reality in the districts (Vadodara in Gujarat and Khammam in AP) where the clinical trials were conducted. Incidentally,the body had earlier opposed the clinical trials.

“They have not even included the age-groups for which the vaccines have been approved. While Gardasil has been approved for the age group of 10-27 years,it has only been tried on a small fraction of patients aged 10-14 years and not adult women. Cervarix has been approved for the age group of 10-45 years,but it has been tested only on a small group of women aged 18-35 years,” said Renu Khanna of the group.

She added that a US-based NGO,PATH,was responsible for conducting these trials with help from the Indian Council of Medical Research (ICMR) and respective state health departments.

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Meanwhile,Solanki said that a three-member ICMR committee has been set up to inquire about the trials and their side-effects on the women in the two states. “The report will be submitted to the Union Health Ministry in about three months,” he added.

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