Union Health Minister Ghulam Nabi Azad Thursday said the use of human papillomavirus (HPV) vaccines imported by pharmaceutical companies Merck and Cervarix was stopped, and rejected the charge that Indian girls were being used as guinea pigs for the trial of the anti-cervical cancer vaccines.
The decision to stop the use of vaccines followed apprehensions that deaths in Andhra Pradesh and Gujarat could have been caused by them, he said replying to a call attention motion moved by Brinda Karat of the CPI(M) in the Rajya Sabha.
“Though prima facie there does not appear to be any connection between the deaths and the vaccination, in order to allay apprehensions the States have been advised not to carry out any further vaccination till further orders.”
Rejecting the charge that guidelines were violated, the Minister said the vaccines were being used in more than 100 countries; the U.S. and the U.K. even included them in their national immunisation programmes.
However, in the fourth phase of the clinical trial (post-marketing), the vaccines would be tested on a large sample of 24,000 girls, higher than [the number of] 21,000 people in the U.S.
Clinical trial of the two HPV vaccines (Gardasil) were allowed in the country in accordance with the Drugs and Cosmetics Act, 1940, and these were available in the market. PATH, a U.S.-based non-governmental organisation, was permitted to carry out an operational research on these vaccines in Khammam district of Andhra Pradesh and Vadodara in Gujarat.
Following the deaths, the Centre constituted a committee of experts to find out the efficacy and safety of these vaccines.
Initiating the discussion, Ms. Karat expressed doubts about the composition of the committee and demanded that eminent medical experts be made part of it. An inquiry should be ordered to find out whether multinationals were given any special preference, and whether the stringent guidelines were violated during the trials.
Ms. Karat, who visited the affected district of Bhadrachalam in Andhra Pradesh, also questioned the credentials the NGO. PATH was a partner of an MNC and had a conflict of interest.
However, Mr. Azad said the organisation was rated quite high in the U.S.
She said the trial was done on children belonging to the Scheduled Castes, the Muslim community and very poor families, and the illiterate parents were not consulted. “Can the government do the same with the children at a public school in Delhi without consulting their parents?”
Mr. Azad said that given the gravity of the disease, India could not afford to lose out on the use of the vaccines just because these were dismissed in certain quarters. But he assured the members that Indian girls would not be allowed to be used as guinea pigs for clinical trials, and the vaccines would be used only after the committee cleared it.
He said four deaths were reported among 14,091 girls vaccinated in Andhra Pradesh and two deaths occurred in Gujarat among 10,686 girls vaccinated. The committee would submit its report in two months.
Jayanthi Natarajan and P.J. Kurien of the Congress and Najma Heptulla of the BJP spoke.