WHO prequalifies India’s first indigenous HPV vaccine Cervavac for global use

Key facts

• Cervavac, India's first indigenously developed gender-neutral quadrivalent human papillomavirus (qHPV) vaccine from the Serum Institute of India (SII), received prequalification from the World Health Organization (WHO), which SII announced on September 5.
• Earlier, the Drug Controller General of India (DCGI) approved Cervavac for use in India to prevent diseases caused by the four HPV variants, including anal cancer in boys and young men and cervical, vulvar, vaginal and anal cancers in girls and young women.
• Cervavac is a recombinant quadrivalent vaccine against HPV types 6, 11, 16 and 18, approved for girls and women aged nine to 26 years to prevent cervical, vulvar, vaginal and anal cancers caused by types 16 and 18 and genital warts caused by types 6 and 11, and similarly approved for boys and men aged nine to 26 years.
• Children aged nine to 14 years receive two doses at 0 and six months, those aged 15 to 26 years receive three doses at 0, two and six months, and the vaccine is administered intramuscularly in 0.5 mL single-dose and 1 mL two-dose vials.
• The vaccine was developed in collaboration with the Department of Biotechnology, the Biotechnology Industry Research Assistance Council, the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation.
• Launched in India in 2022, Cervavac was found non-inferior to Gardasil after phase two trials and is currently undergoing further single-dose efficacy and immunogenicity testing by the Indian Council of Medical Research.
• India records over 1,20,000 new cervical cancer cases and nearly 80,000 deaths annually, the highest death toll worldwide as per the World Health Organization's 2022 report, accounting for nearly 25 per cent of global cervical cancer fatalities, with a new case diagnosed every four minutes and a death occurring roughly every seven minutes.
• India launched a nationwide campaign earlier this year to vaccinate young women with a single dose of Gardasil, another quadrivalent HPV vaccine and one of the six WHO-prequalified HPV vaccines available in the market.