India’s Cervavac HPV Vaccine Receives WHO Safety Approval

Cervavac, India’s first indigenously developed gender-neutral quadrivalent Human Papillomavirus (HPV) vaccine, has received prequalification from the World Health Organization (WHO). The vaccine was developed and manufactured by the Serum Institute of India (SII).

The WHO prequalification marks a significant regulatory milestone for the vaccine and strengthens India’s contribution to global immunisation efforts. With its inclusion on the WHO List of Prequalified Vaccines, Cervavac can now be procured by United Nations agencies for use in eligible countries.

Cervavac targets four HPV types — 6, 11, 16 and 18 — which are associated with several HPV-related diseases, including certain cancers and genital warts.

Serum Institute of India CEO Adar Poonawalla said the WHO prequalification represents an important step in strengthening the global response to HPV. He highlighted the vaccine's potential to help countries expand HPV prevention and immunisation coverage.

Cervavac and HPV-related diseases

Cervavac had previously received approval for use in India from the Drugs Controller General of India (DCGI). It is indicated for girls, boys, women and men aged 9 to 26 years, depending on the specific indication.

For girls and women, the vaccine is indicated to help prevent cervical, vulvar, vaginal and anal cancers associated with HPV types 16 and 18, as well as genital warts caused by HPV types 6 and 11.

For boys and men, Cervavac is indicated for the prevention of anal cancer associated with HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.

Cervavac vaccination schedule

The vaccination schedule varies according to age.

Children aged 9 to 14 years receive Cervavac in a two-dose schedule, with doses given at 0 and 6 months.

Those aged 15 to 26 years receive a three-dose schedule, administered at 0, 2 and 6 months.

Cervavac is administered through intramuscular injection and is available in 0.5 ml single-dose vials and 1.0 ml two-dose vial presentations.

The WHO prequalification of Cervavac represents the 32nd WHO prequalification for products or biologicals received by the Serum Institute of India, further highlighting the company's role in vaccine manufacturing and global immunisation.