Serum Institute HPV Vaccine Cervavac Receives WHO Prequalification
India's first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine, Cervavac, has received prequalification from the World Health Organization, according to an announcement by the Serum Institute of India. The regulatory milestone allows the recombinant vaccine to be procured by United Nations agencies for international immunization programs.
Developed in collaboration with the Department of Biotechnology, the Biotechnology Industry Research Assistance Council, the WHO International Agency for Research on Cancer, and the Gates Foundation, Cervavac targets HPV types 6, 11, 16, and 18. The vaccine is indicated for individuals aged nine through 26 years.
Indications and Dosage Schedule
Previously approved by the Drugs Controller General of India for domestic use, Cervavac is administered intramuscularly to prevent specific cancers and genital warts. For girls and women, it is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18, and genital warts caused by types 6 and 11. For boys and men, the vaccine targets the prevention of anal cancer caused by types 16 and 18, and genital warts caused by types 6 and 11.
The immunization schedule varies by age group. Children aged nine to 14 years receive a two-dose schedule administered at zero and six months. Individuals aged 15 to 26 years receive a three-dose schedule at zero, two, and six months. The vaccine is available in 0.5 mL single-dose and 1 mL two-dose vial presentations.
Addressing India's Cervical Cancer Burden
The WHO prequalification arrives as India continues to address a significant public health burden from cervical cancer. According to World Health Organization GLOBOCAN 2022 data, India reports over 120,000 new cases and nearly 80,000 fatalities annually, representing the highest death toll worldwide and accounting for approximately 25 percent of global cervical cancer fatalities.
Gavi, the Vaccine Alliance, notes that a new case is diagnosed in India every four minutes, while another woman dies approximately every seven minutes. India launched a nationwide vaccination campaign for young women earlier using single-dose Gardasil, another WHO-prequalified quadrivalent vaccine.
Cervavac was initially launched in India in 2022 following phase two trials that found it non-inferior to Gardasil. The Indian Council of Medical Research is currently conducting further single-dose efficacy and immunogenicity testing for the indigenously produced vaccine.
From regulatory milestone to vaccination coverage
WHO prequalification can widen the pool of organisations able to procure Cervavac, but an approval milestone does not vaccinate anyone on its own. Public-health effects depend on procurement, cold-chain capacity, local recommendations and families receiving clear information about eligibility. The vaccine is part of cervical-cancer prevention, alongside appropriate screening and follow-up care. Reports should distinguish the vaccine's assessed quality and procurement status from actual coverage achieved. National rollout data will be a stronger indicator of impact than the recognition announcement alone.