The story so far: The Serum Institute of India’s indigenously developed quadrivalent human papillomavirus (HPV) vaccine, CERVAVAC, has received prequalification from the World Health Organization (WHO), allowing the vaccine to be procured by United Nations agencies and potentially supplied to countries running HPV immunisation programmes. The WHO lists its prequalification as effective from September 25, 2026.
The development is significant for India as well as the global effort to prevent cervical cancer. CERVAVAC is the first Indian-made quadrivalent HPV vaccine to receive WHO prequalification. This prequalification means the vaccine has met WHO standards for quality, safety and efficacy, following evaluation of data, samples and manufacturing sites. The vaccine is a cancer-prevention vaccine and not just a vaccine against an infection.
CERVAVAC is India’s first indigenously developed gender-neutral quadrivalent HPV vaccine and targets HPV types 6, 11, 16 and 18. It is licensed in India for girls and boys aged 9 to 26 years. Globally, cervical cancer caused an estimated 604,000 new cases and 342,000 deaths in 2020. In India, where cervical cancer remains a public-health burden, the national HPV vaccination programme was launched on February 28, 2026, targeting about 1.2 crore 14-year-old girls with a free single dose; more than 80 lakh doses had been administered by September this year, according to the Union Health Ministry. India’s national HPV vaccination programme uses Merck’s Gardasil-4, a quadrivalent vaccine protecting against HPV types 6, 11, 16 and 18.
The organisation recommends either a one- or two-dose schedule for this age group, depending on the vaccine and national programme. The four HPV types targeted by CERVAVAC are important for different reasons. For India, the larger significance is that a vaccine developed and manufactured domestically can now potentially contribute not only to India’s cervical-cancer prevention programme but also to HPV vaccination programmes elsewhere.
The quadrivalent vaccine therefore provides protection against both cancer-associated HPV types and genital warts. WHO’s priority target is girls aged 9–14 years, before exposure to HPV. HPV 16 and 18 are high-risk types responsible for a large proportion of cervical cancers. Types 6 and 11 are responsible for most anogenital warts. Earlier reporting noted: The vaccine targets HPV types 6, 11, 16, and 18. It is indicated for girls and boys aged 9 through 26 years.
Inclusion on the WHO list of prequalified vaccines allows Cervavac to be procured by United Nations agencies, Serum Institute said. It is the 32nd WHO prequalification for products/biologicals received by Serum Institute, the vaccine maker said.
Earlier reporting noted: Serum Institute’s HPV vaccine Cervavac receives WHO prequalification Serum Institute of India’s recombinant Quadrivalent Human Papillomavirus vaccine (qHPV) vaccine Cervavac has received World Health Organization (WHO) prequalification. Earlier reporting noted: The vaccine was developed in collaboration with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), along with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation.
