Cervavac Gains WHO Prequalification for Global Access

The Cliff News | 5 October 2026

India's pioneering gender-neutral quadrivalent Human Papillomavirus (qHPV) vaccine, Cervavac, has achieved a crucial World Health Organization (WHO) prequalification status. Developed by the Serum Institute of India (SII), this regulatory approval marks the 32nd WHO prequalification for products from SII and signifies a major step towards expanding global access to HPV prevention.

The WHO prequalification allows Cervavac to be procured by United Nations (UN) agencies, facilitating its distribution to countries in need. This development is particularly significant for public health initiatives aimed at combating HPV-related cancers and diseases globally.

Global Health Impact of Cervavac

Cervavac targets HPV types 6, 11, 16, and 18, which are responsible for a range of cancers and genital warts. The vaccine is indicated for both boys and girls aged nine through 26 years. This broad age indication and gender neutrality are key features that enhance its public health utility.

Adar Poonawalla, Chief Executive Officer of Serum Institute of India, expressed optimism about the achievement:

WHO prequalification of CERVAVAC® is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare.

 

Vaccine Efficacy and Administration

Previously approved by the Drugs Controller General of India (DCGI), Cervavac is administered for the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It also helps prevent genital warts.

The vaccine's indication for girls and women aged 9-26 years covers prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11. For boys and men aged 9-26 years, it prevents anal cancer caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11.

The administration schedule for Cervavac varies based on age. Individuals between 9 and 14 years receive a two-dose schedule (0.5 mL at 0 and 6 months). Those aged 15 to 26 years are administered a three-dose schedule (0.5 mL at 0, 2, and 6 months). The vaccine is administered intramuscularly and is available in 1-dose vials of 0.5 ml and 2-dose vials of 1.0 ml presentations.