India’s indigenous human papillomavirus (HPV) vaccine Cervavac has received prequalification from the World Health Organization (WHO), clearing a major hurdle for its procurement by UN agencies and potentially expanding access to the vaccine in global immunisation programmes.
Developed by the Serum Institute of India (SII), Cervavac had previously received approval from India’s Drugs Controller General of India for domestic use.
The quadrivalent vaccine is designed for both girls and boys aged nine to 26 and targets four HPV types: 6, 11, 16 and 18. HPV types 16 and 18 are considered high-risk strains associated with several cancers, while types 6 and 11 are commonly linked to genital warts.
Vaccine targets cancer-causing HPV strains
In women, Cervavac is intended to protect against HPV-associated cervical, vulvar, vaginal and anal cancers. In men, it provides protection against HPV-related anal cancer.
According to the Serum Institute, children aged nine to 14 years are given two doses six months apart, while those aged 15 to 26 require three doses administered over a year.
The vaccine uses proteins designed to trigger an immune response against the four targeted HPV strains. It is manufactured using the Hansenula polymorpha expression system.
HPV is a common viral infection and persistent infection with high-risk types can lead to cancers, particularly cervical cancer. Vaccination before exposure to HPV is a key component of prevention strategies.
WHO clearance expands global procurement potential
WHO prequalification is an important benchmark for vaccines intended for use in international immunisation programmes. It assesses products against standards covering quality, safety and efficacy and allows UN agencies and other eligible procurement mechanisms to consider them for purchase.
Serum Institute CEO Adar Poonawalla said the WHO decision marked an important step towards expanding access to HPV vaccination and strengthening efforts to prevent HPV-related diseases.
Cervavac was developed by the Serum Institute in collaboration with India’s Department of Biotechnology, the Biotechnology Industry Research Assistance Council (BIRAC), the WHO’s International Agency for Research on Cancer (IARC) and the Gates Foundation.
The WHO prequalification could now broaden the vaccine’s potential reach beyond India, particularly through international procurement and immunisation programmes targeting HPV-related diseases.