The Indian Council of Medical Research (ICMR) has told Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination programme for girls. The programme is part of a two-year study to look into the utility of a vaccine in public health programmes and acceptability of Gardasil, the human papillomavirus (HPV) vaccine made by Merck. Gardasil, available in medical stores across the country, is marketed in India by MSD Pharmaceuticals Pvt Ltd.
The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche. Women activists fear the vaccine may impact the mental health of girls who have shown no signs of distress so far.
Health ministry sources said the vaccination programme is being conducted by Gardasil, jointly with PATH, a Seattle-based NGO, ICMR and the two state governments. About 32,000 girls, aged 10-14, were to be tested in the study.
ICMR chief Dr VM Katoch clarified ICMR was only a technical partner, with an advisory role, in the project. But Katoch said they were checking out who was at fault.
Questioning the study, CPM leader Brinda Karat said: “How has the government embarked on the study of giving three injections to the girls when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?”
For a drug to be administered to children, Karat said, it has to go through stages of clinical trial, including phase 3 adult clinical trials. With Gardasil, only one trial has been carried out with a small sample of 110 girls, which has followed up with them for a month after completion of vaccination and that too only to look at the immune response post-vaccination, Karat said. The vaccine has also been approved for adult women aged 27, Karat said, without any trials on them.
Karat also alleged scientific logic and ethical guidelines have been violated at each step during drug and vaccine trials.