Cervical vaccines like Gardasil and Cervarix in India have met with another hurdle as the main oppostion party in the country’s north-eastern state of Assam questioning the efficacy and validity of the vaccines.
Assam has the highest number of cervical cancer incidences in India, according to figures by the National Cancer Registry.
Assam also claims to be the first Indian state to launch the free vaccination drive against cervical cancer.
In an effort to control the increasing incidence of cervical cancer in Assam, the ministry of the state has announced a programme to vaccinate 100,000 girl students against cervical cancer spending Rs.600 million from the public exchequer.
As soon as the announcement came out the main opposition Asom Gana Parishad (AGP) opposed the programme questioning the effectiveness of the vaccine to prevent cervical cancer in young girls in India.
AGP has also raised questions on the validity of the cervical cancer vaccines like Gardasil or Cervarix asking whether the campaign was approved by health experts.
“We think the campaign is being done in haste. We need to know if any expert health committee has cleared or recommended the project being introduced,” senior AGP leader Bijon Mahajan was quoted as saying in reports.
Since such a huge amount of public money is involved, AGP wanted to know if at all the vaccine would yield effective results.
Some section of health experts, however, said AGP’s apprehensions are misfounded. Both the cervical cancer vaccines Gardasil and Cervarix are approved for use in girls by various regulatory agencies including US FDA across the world after finding that they are effective in preventing cervical cancer causing human papillomavirus (HPV) and safe in humans.
The need of the hour, therefore, is to contain the increasing incidence of cervical cancer in Assam and not spreading panic among the public about its safety, they warned.
In April, Indian government suspended Merck’s cervical cancer vaccine Gardasil study in two states following reports of deaths of 4 girls and several complications.
Gardasil was to be tested for its “acceptability and service delivery issues” in about 32,000 girls aged 10-14 in the southern Indian state of Andhra Pradesh and Western state of Gujarat.
Gardasil vaccination programme is being conducted jointly with PATH, a Seattle-based NGO, the Indian Council of Medical Research (ICMR) and the two state governments. The vaccination drive is funded by the Bill and Melinda Gates Foundation
PATH-International, which is conducting the study for the maker of Gardasil Merck, an American pharmaceutical company since July 2009, has described the study as a “demonstration project.”
The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to prevent cervical cancer among women, has been alleged to have led to the death of the four girls who were administered the dose in Khammam district of Andhra Pradesh.
Besides the death, more than 120 girls, who were given the vaccination, have complained severe adverse reactions of stomach disorders, epilepsy, headaches and early menarche.
The cervical cancer vaccination study is not part of the universal immunisation programme of the country and PATH had claimed it was a promotional programme for the vaccine in India. ICMR had clarified that it was, indeed, a clinical trial, human rights NGOs alleged.
Villagers in these states were told that Garadasil was an expensive vaccine and that they would not be able to afford it once the company’s project was over, hence they should get their daughters vaccinated, they alleged.
MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc USA launched Gardasil a quadrivalent human papillomavirus vaccine. Gardasil is the only vaccine that helps protect against 4 types – types 6, 11, 16, 18 – of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV, MSD said while announcing the launch.
Gardasil is recommended to be given to females aged between 9 to 26 years.