The World Health Organisation's Strategic Advisory Group of Experts on Immunization (SAGE) committee has stated that one dose of the Human Papillomavirus Vaccine is effective against the cervical cancer-causing Human Papillomavirus and has recommended a one dose regimen for girls between the ages of 9-14.
According to the committee, this recommendation could be a game-changer to prevent the spread of cervical cancer which is often referred to as the silent killer and is preventable. As the fourth most common cancer among women, the scope of prevention is limited due to the inequity in accessing this life-saving jab for girls and women. About 25 per cent of women who die from cervical cancer annually are from India.
Normally given as a two or three dose regimen, the recommendation to decrease the dosage is a step toward ensuring that the vaccine becomes a part of immunisation schedules across the world. In India, Delhi, Punjab, and Sikkim are few of the states that have incorporated the vaccine into their programs for vaccinating girls but it is still not a part of the national programs.
The currently available vaccines are expensive as they stand at about ₹2,000 to ₹3,000 a dose and it was earlier a two-to-three dose regimen. Additionally, when the vaccine was launched in the country in 2008, it faced several ethical issues when studies were being launched to study the effectiveness of the same.
Although the National Technical Advisory Group on Immunisation (NTAGI) in 2017 had recommended for the inclusion of the HPV vaccine in India's Universal Immunisation Programme, the Government has not taken any measures in the particular direction. While the Indian Academy of Pediatricians has included the vaccine for girls between 9-14, it is not mandatory for children to receive it.
When the WHO is trying to achieve universal access to the vaccine, especially in the low- and middle-income countries, there continue to be hurdles in the road to eliminating cervical cancer. The WHO intends to fully vaccinate 90 per cent girls of 15 years of age with two doses of HPV vaccine by 2030.
WHO Recommendations For HPV Vaccine
More than 95% of cervical cancer is caused by sexually transmitted HPV. HPVs, a class of DNA viruses are of 14 types of which 16 and 18 are related to 70 per cent cervical cancers. Cervical cancer can also be caused due to continuous smoking, birth control pills, and other sexual disorders such as chlamydia.
In a statement, Dr Alejandro Cravioto, SAGE Chair said, "SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes."
The new recommendations state a one or two-dose schedule for the primary target of girls aged 9-14, a one or two-dose schedule for young women aged 15-20, and two doses with a 6-month interval for women older than 21. If there are any immunocompromised individuals, including those with HIV, they should receive three doses if feasible, and if not at least two doses as there is limited evidence regarding the efficacy of a single dose in this group.
The general belief stands that the vaccine should be given to women before they become sexually active or by the age of 26. The vaccine was found to reduce incidence of cervical cancer by 90 per cent in a study of 1.7 million women as compared to those who had not received the vaccine before they were 17.
To further accelerate achieving the goal of vaccinating 90 per cent girls by the age of 15, the WHO also launched the Cervical Cancer Elimination Initiative in 2020. The other goals of the initiative include screening of 70 per cent women with a high-performance test at 35 and 45 years of age and 90 per cent of women diagnosed with cervical pre-cancer and cancer receiving treatment to achieve a goal of less than four cases per 100,000 women.
In the same year as the initiative, the global coverage of two doses was only 13%. According to the WHO, several factors influence the slow uptake and low coverage of HPV vaccines including supply challenges, and the relatively high cost of HPV vaccines, particularly for middle-income countries. SAGE officials believe that the push towards a single dose regimen is beneficial as 'it is less costly, less resource intensive and easier to administer. It facilitates implementing catch-up campaigns for multiple age groups, reduces the challenges linked to tracing girls for their second dose and allows for financial and human resources to be redirected to other health priorities.'
When diagnosed, cervical cancer is one of the most successfully treatable forms of cancer, as long as it is detected early and managed effectively.
Cervical Cancer In India
In 2020, Globocan estimated 123,907 incident cases and 77,348 deaths, with an age-standardized incidence rate of 18 per 100,000 women in India. It contributes to one-fifth of the global burden. The 5-year relative survival rate of approximately 46% (range 34–60%) is much lower than that of other Asian countries. This is because cervical cancer in the country is not diagnosed at earlier stages when it is preventable in close to 80 per cent of the cases resulting in high mortality.
A 2021 study by gynecologists at All India Institute of Medical Sciences to study the Cervical Cancer prevention mechanisms in India found that 80% of cervical cancer and 63% of high-grade lesions in India are linked with infection due to HPV 16 and 18, which is greater than the global average.
This study shared that India was using cytology (pap smears), co-testing (HPV + cytology), primary HPV testing, and visual inspection with acetic acid in various settings. There, however, was aneed to strengthen efforts by developing an affordable, point-of-care HPV test for low- and middle-income countries. India also needed to speed up its HPV vaccination.
The study also pointed that professional organizations like FOGSI, Asia-Oceania Research Organization in Genital Infection and Neoplasia (AOGIN-India), Indian Society of Colposcopy and Cervical Pathology (ISCCP) and Association of Gynaecologic Oncologists of India (AGOI) have contributed to cervical cancer prevention strategies by developing screening guidelines, conducting screening outreach camps and conducting awareness talks across the country, using innovative strategies like the Lifeline Express to reach remote areas and collaborating with corporate and paramedical organizations.
While Delhi, Sikkim, Punjab have incorporated the vaccine, the Indian government is yet to include the vaccines in the national programs.
Problems With Uptake Of HPV Vaccine In India
Currently, India has two HPV vaccines- one produced by GlaxoSmithKline and the other by Merck. Cervarix by GlaxoSmithKline is a bivalent vaccine that protects against infection by two HPV strains – type 16 and type 18. Gardasil by Merck, is a quadrivalent vaccine that provides protection against four HPV strains – types 16, 18, 6 and 11. Types 6 and 11 mainly cause genital warts which are considered to be additional risk factors for cervical cancer.
Both of these are charged exorbitantly at ₹2,000 to ₹3,000 a dose. Along with the high cost of the vaccine, there are issues about its efficacy and safety, too. When the NTAGI had recommended for the inclusion of the vaccine in the immunisation schedule, Dr. Soumya Swaminathan, Chief Scientist at the WHO, urged that the vaccine be included. The Swadeshi Jagran Manch, an affiliate of the Rashtriya Swayamsevak Sangh wrote to the government requesting that the vaccine not be introduced as they were alleged to have the highest rate of adverse side effects. The WHO debunked this claim by stating that they did not find any causal link between the vaccines and effects.
Along with this letter, in 2009, a year after the vaccines were launched in the country, the Public Health Foundation of India declined to partake in two clinical trials for the vaccines in Andhra Pradesh and Gujarat. American non-profit PATH was conducting trials which were said to have endangered the life of 13,000 girls in Andhra Pradesh and 10,000 girls in Gujarat aged 10–14.
After seven girls who had received the vaccines in the trials reportedly died, the government halted the trial in March 2010. A government enquiry found that these deaths were unrelated to the vaccines. but it was later found that the study violated ethical norms and India's laws and regulations.