Cervical cancer remains a significant public health challenge in India, with an estimated 123,000 new cases and 77,000 deaths annually. The primary cause of cervical cancer is persistent infection with high-risk types of human papillomavirus (HPV), particularly types 16 and 18. Vaccination against HPV is the most effective preventive measure, but conventional multi-dose schedules (two or three doses) have faced operational and coverage challenges, particularly in resource-limited or hard-to-reach populations.
WHO Endorsement of Single-Dose HPV Vaccines
In October 2024, the World Health Organization (WHO) formally endorsed the use of single-dose HPV vaccination for certain vaccines, particularly Cecolin®, based on robust evidence of long-term immunogenicity and protection. This endorsement was informed by:
Long-term follow-up studies demonstrating durable antibody responses with a single dose.
Evidence of high vaccine efficacy against persistent HPV 16/18 infection, the principal cause of cervical cancer.
Modeling studies showing that single-dose vaccination can substantially increase coverage and reduce programmatic costs, especially in low- and middle-income countries.
The WHO recommendation allows countries to adopt single-dose schedules programmatically, either as part of catch-up campaigns or routine immunization programs, while maintaining safety and effectiveness.
Indian Evidence and IARC-Linked Studies
India has been at the forefront of HPV research. IARC-linked cohort studies in India, following thousands of girls and women for over 10 years, have shown:
Single-dose vaccination provides durable protection against HPV 16/18, comparable to multi-dose schedules.
Long-term seropositivity remains high, indicating sustained immune protection.
Modeling based on Indian epidemiology predicts that single-dose vaccination of girls aged 9–14 could avert nearly one million cervical cancer cases over the lifetimes of current cohorts.
These findings provide a strong local evidence base for policymakers, aligning international guidance with India-specific data. .
Policy Considerations for India
Vaccine Choice and Procurement
WHO-prequalified vaccines like Cecolin® can be used immediately in a single-dose program.
Domestic vaccine (Cervavac, Serum Institute of India) is currently licensed for two-dose schedules; immunobridging trials are ongoing to support potential single-dose adoption.
Target Population and Age Group
Single-dose vaccination is most effective for girls aged 9–14, prior to potential exposure to HPV.
Catch-up strategies may be considered for older adolescents and special populations, following programmatic guidance.
3. Integration into the UIP
The Universal Immunization Programme (UIP) provides an ideal platform for nationwide implementation.
Single-dose scheduling simplifies logistics, reduces cold-chain demand, lowers costs, and improves coverage in rural and hard-to-reach areas.
Safety and Monitoring
Continued AEFI surveillance is essential, integrated into existing UIP mechanisms.
Long-term monitoring of vaccine effectiveness through infection and precancer endpoints ensures program accountability.
Equity and Awareness
Inclusion in the UIP ensures equitable access for all eligible girls, irrespective of socioeconomic status.
Robust communication campaigns targeting parents, teachers, and community leaders are essential to address vaccine hesitancy and explain the efficacy of single-dose schedules.
Special Populations
Multi-dose schedules should be maintained for immunocompromised adolescents (HIV, transplant patients) or those with prior HPV exposure, until further evidence supports single-dose efficacy.
Recommended Policy Pathway
Interim Use of WHO-Approved Single-Dose Vaccines: Begin phased rollout using vaccines like Cecolin® in select states or target populations.
Accelerate Domestic Evidence Generation: Complete immunobridging studies for Cervavac to support potential single-dose licensure.
Phased National Rollout: Expand coverage gradually, leveraging UIP infrastructure and school-based campaigns.
Monitoring and Evaluation: Implement robust AEFI and effectiveness surveillance, tracking coverage, infection rates, and precancer incidence.
Community Engagement: Develop clear messaging campaigns to build trust and awareness among parents, adolescents, and communities.
Conclusion
The WHO single-dose recommendation, combined with robust Indian evidence from IARC-linked studies, provides a unique opportunity for India to accelerate cervical cancer prevention. Single-dose HPV vaccination is cost-effective, operationally feasible, and equitable, and its inclusion in the UIP can help India move closer to WHO’s cervical cancer elimination goals.
A phased, evidence-based approach, integrating WHO guidance, local trial data, and programmatic readiness, can ensure that the benefits of HPV vaccination reach every eligible girl across the country.