Pune, 5th October 2026: India’s first indigenously developed Human Papillomavirus (HPV) vaccine, Cervavac, manufactured by the Serum Institute of India (SII), has received prequalification from the World Health Organisation (WHO).
The regulatory milestone allows Cervavac to be included in the WHO list of prequalified vaccines, making it eligible for procurement by United Nations agencies for global distribution.
The achievement marks the 32nd WHO prequalification for a biological product received by the Serum Institute of India. WHO prequalification is an important step for vaccines seeking to enter international immunisation programmes, particularly those supported by UN agencies.
Cervavac is a recombinant quadrivalent HPV vaccine that targets HPV types 6, 11, 16 and 18. These HPV strains are associated with several cancers and other diseases. The vaccine is indicated for girls, boys, women and men between 9 and 26 years of age.
In girls and women, Cervavac is indicated for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18, as well as genital warts caused by HPV types 6 and 11. In boys and men, it is indicated for preventing anal cancer linked to HPV types 16 and 18 and genital warts caused by types 6 and 11.
Serum Institute of India CEO Adar Poonawalla said the WHO prequalification strengthens the global response to HPV and creates an opportunity for countries to expand prevention efforts. He said the milestone reflects the effectiveness of Cervavac and expressed the company’s commitment to supporting wider immunisation coverage and global healthcare.
Cervavac was developed through a 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, along with the Serum Institute of India. The vaccine was previously approved for use in India by the Drugs Controller General of India (DCGI).
Cervavac is administered through an intramuscular injection. Individuals aged 9 to 14 years receive the vaccine under a two-dose schedule, while those aged 15 to 26 years receive three doses. The vaccine is available in single-dose and two-dose vial formats.
The WHO prequalification marks an important step for an Indian-developed HPV vaccine to reach international immunisation programmes. Its inclusion on the WHO prequalified list could help UN agencies procure Cervavac and support broader access to HPV vaccination in countries seeking to strengthen prevention of HPV-related diseases and cancers.
