India prepares to introduce HPV vaccine in National Immunization Program
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P Basu & I Baussano (September 2024). India prepares to introduce HPV vaccine in National Immunization Program. www.HPVWorld.com, 273
The Finance Minister of India, in her budget speech on February 1st 2024, announced the introduction of HPV vaccination for girls as a national priority.1 Contemplating a phased implementation approach, the Ministry of Health notified seven states to prepare for vaccine launch targeting girls aged 9 years (with a multi-age cohort aged 10–14 years).2 Vaccination will be rolled out primarily through schools targeting girls in 5th-l0th grade.3
India introducing the vaccine in the national immunization program (NIP) will be a significant step towards global cervical cancer elimination, as the country alone contributes towards one-fifth of total cervical cancers occurring in the world. Once the program is rolled out nationally, nearly 68 million girls aged 9-14 years in the first round and 11 million 9-year-old girls every subsequent year would require vaccines.2 The fiscal implications are huge, especially because India spends less than 3% of GDP on public expenditure on health. The recommendation from WHO published in 2022 to vaccinate girls and boys with a single dose has high relevance for India.4 Already, several countries have launched HPV vaccination programs with a single dose or switched from two to one dose.
One of the key studies generating evidence to inform the WHO recommendation is from India. In this study, a cohort of 10–18-year-old unmarried girls sampled from seven states were vaccinated in 2009-10. The girls received either three doses (N=4348), two doses (N=4980) or a single dose (N=4949) of GardasilTM and are being followed up over the last 15 years. Vaccine efficacy against persistent HPV 16/18 infections at nearly 10 years of follow-up was 95.4% (95%, CI 85.0–99.9), which was comparable to that observed in two-dose recipients 93.1% (95%, CI 77.3–99.8) or three-dose recipients 93.3% (95%,CI 77.5–99.7).5 Binding antibodies against HPV 16 and HPV 18 were detectable in 96% and 97% of the single-dose recipients, respectively, 10 years post-vaccination, and mean titres were significantly higher in them compared to unvaccinated women.6 These results were corroborated by other studies, including a randomized trial conducted in Kenya.7 Modelling based on equal protective efficacies of single and two doses has shown that by launching the vaccination programme with a single dose, India would prevent close to 1 million cases of cervical cancer in the lifetime of the 120 million Indian girls currently aged 10 years and younger, which would be cost-effective and sufficient to meet the WHO-defined elimination target across India. Of note, the relative per-dose efficiency to prevent cervical cancer of single dose schedule would be higher than two-dose vaccination even in the unlikely case of waning of protection decades after vaccination (Figure 1).8,9
An indigenously produced quadrivalent HPV vaccine (CervavacTM) was launched in India in 2023, following a phase II/III randomized trial demonstrating immunological equivalence with GardasilTM in females and males aged 9-26 years. The manufacturers have committed adequate supply of the vaccine at an affordable price for the NIP. Indian National Technical Advisory Group on Immunization (NTAGI) approved CervavacTM for introduction in NIP as a two-dose regimen. They sought data on immunogenicity and protection from infection for up to two years before approving a single dose of CervavacTM.10
India must be pragmatic in its strategic planning for HPV vaccine introduction. In addition to saving resources, a single-dose regimen avoids the logistic complexities of tracking the girls to administer the second dose. Resources saved may be used to vaccinate boys. Gender-neutral vaccination has several advantages – faster elimination of infection through robust herd immunity, a more resilient programme, protection of boys against anal and oropharyngeal cancers and avoiding stigma associated with a girls-only vaccine. Indian regulators and NTAGI may consider a process of faster approval of CervavacTM through the successful demonstration of immune-equivalence with a single dose of GardasilTM. Launching the programme with an extended interval between two doses (3-5 years as recommended by WHO)4 leaves space for correction of the vaccination schedule when CervavacTM is approved for a single dose.
DISCLOSURE
The Authors declare no conflict of interest to disclose.
DISCLAIMER
Where authors are identified as personnel of the International Agency for Research on Cancer/World Health Organization, the authors alone are responsible for the views expressed in this article, and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer /World Health Organization.
References
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10. Government of India. Ministry of Health & Family Welfare Immunization Division. 18th National Technical Advisory Group on Immunization (NTAGI) Meeting: Minutes of the Meeting. July 26, 2023. Available from: https://mohfw.gov.in/sites/default/files/Minutes%20of%20Meeting-%2018TH%20NTAGI-%20July%20%272023.pdf Last accessed on 2024/07/18.