Anti-cervical cancer programme using HPV vaccine Gardasil in Bhutan

Merck’s cervical cancer vaccine Gardasil will be offered to girls and young women between the ages of 12 and 18 in Bhutan.

Bhutan’s national cervical cancer vaccination programme has been launched through a collaboration with the Royal Government of Bhutan, Merck Sharp & Dohme (MSD) and the Australian Cervical Cancer Foundation (ACCF) as a preventive measure against human papillomavirus quadrivalent (Types 6, 11, 16 and 18) girls and young women in the country. Related: Cervical cancer in India

Cervical cancer affects more women in Bhutan than any other cancer.

As part of the 6-year programme, Merck will provide Gardasil vaccine free to the programme partners in the first year. Gardasil will be provided at a concessional rate for the remaining five years.

Merck will also provide additional support for implementation of the program.

The Royal Government of Bhutan is committed to ensuring sustainability of this programme beyond the six year partnership with Merck and ACCF.

Bhutan is the first low income country in the world to implement a national vaccination programme with an HPV cancer vaccine.

Cervical cancer represents a significant public health problem for Bhutan and the impact on affected women, their families and their communities is great.

ACCF, a charity whose mission is to minimize the incidence and burden of cervical cancer and related women’s health issues on women is supporting the national vaccination programme by providing financial support to the Government of Bhutan to secure doses of Gardasil at the access price after the first year of the programme is complete.

Merck’s Gardasil has been in the spotlight following deaths of 6 girls in India during a cervical cancer vaccination study.

Cervical cancer vaccine Gardasil study, which has allegedly led to the death of 6 girls in Indian village of Khammam, was conducted in children before evaluating its safety in adult girls, senior officials with Indian government has stated.

According to the clinical trial guidelines being practised in India, any trial of drug or vaccine cannot be conducted on children until a similar trial was held on adults. This practice was not adhered to while conducting studies using Merck’s cervical cancer vaccine Gardasil trials in India, reports said quoting the secretary of Department of Health Research, under Union Ministry, Government of India. Related story: Cervical cancer vaccines in India

The secretary, however, said the vaccine is supposed to be given before sexual activity begins to protect against cancer and therefore it was used on young girls aged 10-14 years.

A high level three-member committee formed by the Union health ministry is trying to probe the link between cervical cancer vaccine Gardasil and the death of four girls in Andhra Pradesh.

Four deaths in the target of 14019 in Andhra and two in the target of 10,686 in Gujarat have been reported from among the children who were administered these vaccines.

The cause of deaths was determined as viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite. Based on the concerns on these deaths, States have been advised not to carry out any further vaccinations at present.

For assessing the health services needs and preparedness for introducing Human Papilloma Virus (HPV) vaccines into the health services in future, PATH, an international NGO, was given permission for a post licensure observational study of HPV vaccination in Khammam district (Andhra Pradresh) and Vadodara district ( Gujarat).

The study by PATH, was recommended by the Ethical Committee and Advisory Groups at State and Central level. Indian Council of Medical Research, an autonomous body under the Ministry has provided technical support for the development of protocols, and advised on ethical issues as per Govt. of India guidelines, the release stated.

Two imported brands of Human Papilloma Virus (HPV) vaccines namely Gardasil (imported by M/s MSD Pharmaceuticals, Gurgaon) and Cervarix (imported by M/s GSK Pharmaceuticals, Mumbai), were allowed to undergo clinical trial (Phase III) in India, before granting permission to import and Market Authorization.

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.”

Gardasil is approved in the US for use in girls and young women nine through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

Gardasil is also approved in the US for use in boys and men ages 9 through 26 years of age for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11.

HPV types 16 and 18 account for approximately 75 per cent of cervical cancer cases.