CERVAVAC Becomes India's First WHO-Prequalified Indigenous HPV Vaccine

CERVAVAC Becomes India's First WHO-Prequalified Indigenous HPV Vaccine

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Key takeaways

  • The Serum Institute of India secured WHO prequalification for CERVAVAC on 25th September 2026, marking India's first indigenous HPV vaccine to achieve this global milestone.
  • The vaccine is approved for individuals aged 9 to 26 years, utilizing a two-dose schedule for younger ages and a three-dose schedule for older recipients.
  • Protection covers four HPV types, specifically types 6, 11, 16, and 18, which prevent cervical cancer and genital warts.
  • More than 80 lakh doses were administered across India under the national immunization program by September 2026.
  • Founded in 1966 in Pune, Maharashtra, the Serum Institute of India is the world's largest vaccine producer by volume.

Why in News

  • The Serum Institute of India created history by securing WHO prequalification for CERVAVAC on 25th September 2026.
  • This achievement marks India's first indigenously developed human papillomavirus vaccine to earn global endorsement.
  • The approval makes the vaccine eligible for direct procurement by international organizations and global immunization programs.

Key Features of CERVAVAC

  • The vaccine was designed and manufactured by the Serum Institute of India with backing from the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC).
  • Additional support for its creation came from the Gates Foundation and the WHO's International Agency for Research on Cancer (IARC).
  • CERVAVAC serves as India's premier gender-neutral quadrivalent vaccine, authorized for administration to children and young adults aged 9 to 26 years.
  • The immunization timeline requires a two-dose schedule for individuals aged 9 to 14 years and a three-dose schedule for those aged 15 to 26 years.
  • Protection is provided against four HPV types, specifically types 6, 11, 16, and 18.
  • High-risk strains 16 and 18 are directly linked to cervical and related cancers, whereas types 6 and 11 are responsible for genital warts.

Significance of WHO Prequalification

  • The evaluation by the WHO guarantees that the vaccine adheres to strict global standards for quality, safety, and effectiveness.
  • Regulatory validation relies on comprehensive reviews of product data, manufacturing protocols, and production facilities.
  • While not a direct substitute for local market authorization, the certification delivers globally recognized assurance for international procurement agencies.

India's HPV Vaccination Programme

  • The national immunization drive began on 28th February 2026, offering free inoculations to eligible 14-year-old girls using a single-dose format of Gardasil-4.
  • Securing international prequalification for CERVAVAC does not instantly guarantee its automatic integration into the ongoing national immunization schedule.
  • Data released by the Union Health Ministry shows that more than 80 lakh doses were successfully administered across the country by September 2026.

Global Health Objectives

  • The milestone directly contributes to the overarching WHO strategy aimed at global cervical cancer elimination.
  • The international roadmap targets 90% HPV vaccination coverage for girls by the age of 15 by the year 2030.
  • Additional global goals include achieving 70% cervical screening coverage and ensuring proper treatment for 90% of women diagnosed with precancerous conditions or cancer.

About Serum Institute of India

  • Established in 1966 by Cyrus Poonawalla, the organization maintains its headquarters in Pune, Maharashtra.
  • The company currently stands as the largest vaccine manufacturer in the world when measured by the total volume of doses produced.