HPV vaccination in India: How far we have come?

In 2020, WHO – Director-General had called for all countries to take action against cervical cancer. The vision was a world without cervical cancer, with a proposed elimination threshold to reach <4 cases per 100,000 women/year. The control target strategy outlines three measurable global targets to prevent and treat cervical cancer by the year 2030:

• 90% of girls should be fully vaccinated with HPV vaccine by 15 years of age
• 70% of women needs screening by the age of 35 years and again by the age of 45 years
• 90% of those identified with cervical disease should receive appropriate treatment

Reason to include HPV vaccination in the program

Scaling-up of both girls-only HPV vaccination and twice-lifetime screening is necessary. If this global elimination strategy of combined intensive scale-up of HPV vaccination and cervical screening can be achieved, the results suggest that cervical cancer elimination could be achieved in all countries by 2100. According to epidemiological modelling, 90% female-only vaccination coverage will dramatically reduce cervical cancer incidence in every country. Due to the herd effect, a huge reduction is possible in HPV infection in men and older women.

Response from India

In 2002, WHO initiated talks with Indian scientists and health officials about starting clinical trials investigating the efficacy of HPV Vaccination in India. In 2008, bivalent and quadrivalent vaccines were given licence in India, after which IARC conducted multicentric studies performing clinical trials and started recruiting two doses versus three doses. But the Government of India suspended HPV vaccination in all clinical trials after a series of deaths reported in Telangana and Gujarat among vaccinated girls. Later, the causes of death were under scrutiny by an Inquiry Committee appointed by the Government of India and was found that deaths were not related to vaccination. Girls who received single-dose vaccines were followed and it was found that even single-dose vaccines are very effective. This serendipitous finding led to further research, based on which, WHO recommends reduced dose HPV vaccination now.

HPV vaccines licensed in India

Gardasil: It targets four strains of human papillomavirus (HPV) — HPV-6, 11, 16, and 18 and is licensed in India only for females.

Gardasil-9: Licensed for use in India since 2018, it prevents infection with the nine HPV types. Besides 6,11,16 & 18, it contains five other high-risk HPV types 31, 33, 45, 52, and 58, that account for an additional about 10% of cervical cancers. As per its license, it is for both females and males in India.

Cervarix: It is for girls and young women aged 9 to 25 years to prevent cervical cancer caused by certain types of HPV (types 16 and 18). Licensed in India for use in females only.

Cervavac: It targets four strains of human papillomavirus (HPV) – HPV-6, 11, 16, and 18. This is India’s first indigenous vaccine available in the market since January 2023. India’s first homegrown HPV vaccine can be a game changer as it will be more affordable and accessible. As per its license, it is for both the sexes in India. CERVAVAC has demonstrated a robust antibody response and 100% seroconversion across all 4 serotypes (Serotypes 6, 11, 16, 18). 

Schedule: Age & dosage Recommendations (FOGSI GCPR guidelines, 2024)

• Preferred target age group 9-14 years. Two doses: 0 & 6 months (the second dose may be given at 5-15 months)
• Delayed vaccination (15-26 years) Three doses: 0, 1, 6 months (Bivalent) & 0, 2, 6 months (Quadrivalent & Nonavalent)
• Older age groups (27-45 years) Three doses: 0, 1, 6 months (Bivalent) & 0, 2, 6 months (Quadrivalent & Nonavalent).
• Women aged > 26 years who have been sexually active needs counselling regarding reduced efficacy in older age groups and the importance of screening.

FOGSI GPCR, 2024: HPV Vaccination

New recommendation by WHO (December 2022)

• A one or two-dose schedule for girls aged 9-14 years
• A one or two-dose schedule for girls and women aged 15-20 years
• Two doses with a 6-month interval for women older than 21 years

Screening in HPV-vaccinated women

Administer HPV vaccines intramuscularly in the deltoid region of the upper arm. HPV vaccines do not protect against all HPV types that can cause cancer. Jabbed women should follow the same screening recommendations as unvaccinated women.

Cervical cancer is preventable. We can put an end to it by boosting public awareness and providing access to information and services. WHO’s global strategy to eliminate cervical cancer as a public health problem is by securing sufficient and affordable HPV vaccines, increasing the quality and coverage of vaccination, improving communication and social mobilisation and further innovating more to improve the efficiency of vaccine delivery. The availability of a new indigenous HPV vaccine is a welcome move to address the vaccine shortage. Single-dose HPV vaccine will substantially reduce the programmatic cost with equal efficacy and safety and not implemented yet. Furthermore, combining 90% female-only vaccination coverage with 70% screening coverage (as in the 90–70-90 strategy) can substantially bring down cervical cancer cases by 2030.

This article is co-authored by Dr Nilanchali Singh, MBBS, MD, Fellowship in Gynaecologic Oncology, Associate Professor, AIIMS, New Delhi.

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