CERVAVAC, India’s first indigenously developed gender-neutral quadrivalent Human Papillomavirus (HPV) vaccine manufactured by the Serum Institute of India (SII), has received World Health Organization (WHO) prequalification, marking a major milestone for India’s HPV vaccine programme and global immunisation efforts. The WHO prequalification became effective on September 25, 2026.

The WHO listing enables United Nations agencies to procure CERVAVAC for immunisation programmes. The milestone is also the 32nd WHO prequalification for products and biologicals received by the Serum Institute of India.
CERVAVAC is a recombinant quadrivalent HPV vaccine targeting HPV types 6, 11, 16 and 18 and is indicated for girls and boys aged 9 through 26 years. In India, the vaccine had previously received approval from the Drugs Controller General of India (DCGI).

For girls and women aged 9–26 years, CERVAVAC is indicated for prevention of cervical, vulvar, vaginal and anal cancers associated with HPV types 16 and 18, as well as genital warts caused by types 6 and 11. For boys and men in the same age group, it is indicated for prevention of anal cancer caused by HPV types 16 and 18 and genital warts caused by types 6 and 11.
The vaccine is administered intramuscularly. Individuals aged 9–14 years receive two doses at 0 and 6 months, while those aged 15–26 years receive three doses at 0, 2 and 6 months. CERVAVAC is available in 0.5 mL single-dose vials and 1.0 mL two-dose vials. WHO lists a 36-month shelf life when stored at 2–8°C.

CERVAVAC was developed through collaboration involving the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), WHO’s International Agency for Research on Cancer (IARC) and the Gates Foundation.
Serum Institute CEO Adar Poonawalla said the WHO prequalification strengthens the global response to HPV and creates an opportunity for countries to expand access to preventive vaccination.

WHO describes prequalification as a benchmark for the quality, safety and efficacy of vaccines and other health products and notes that prequalified products become eligible for procurement by UN agencies and other international procurement partners.
The WHO prequalification of CERVAVAC therefore represents an important step in expanding access to an Indian-developed HPV vaccine and strengthening global efforts to prevent HPV-associated diseases.