CERVAVAC: India’s First Indigenous HPV Vaccine Receives WHO Prequalification
The World Health Organization (WHO) has granted prequalification to CERVAVAC, making it the first Indian-made quadrivalent human papillomavirus (HPV) vaccine to meet global standards for quality, safety, and efficacy.
- It is India’s first indigenously developed, gender-neutral quadrivalent Human Papillomavirus (qHPV) vaccine designed as a preventive oncology vaccine to protect against cervical cancer and HPV-related diseases.
- Developed by: Manufactured and developed indigenously by the Serum Institute of India (SII), Pune.
- Targeted HPV Strains:
- High-Risk Oncogenic Strains (Types 16 and 18): Responsible for over 70% to 80% of all cervical cancer cases globally.
- Low-Risk Strains (Types 6 and 11): Responsible for causing approximately 90% of anogenital warts (condyloma acuminata).
Key Features of CERVAVAC:
- First Indigenous Prequalified HPV Vaccine: Stands as the first Indian-manufactured quadrivalent HPV vaccine on the WHO List of Prequalified Vaccines, joining an international pool previously dominated by foreign manufacturers.
- Broad Age & Gender-Neutral Indication: Licensed in India for administration to both girls and boys aged 9 to 26 years, enabling herd immunity and preventing male HPV burdens such as anal cancers and genital warts.
- Affordable & Scalable Production: Engineered to be substantially more cost-effective than imported counterparts, leveraging SII’s mass-scale manufacturing to address global supply crunches.
- Flexible Dosing Regimen: Compatible with WHO-recommended schedules, supporting both single-dose or two-dose regimens for the primary target group of adolescents aged 9 to 14 years.
- Rigorous InternationalQuality Benchmark: Validated through extensive clinical evaluations, batch testing, and manufacturing facility audits to meet the stringent safety and immunogenicity guidelines of the WHO.
