India’s first indigenously developed gender-neutral quadrivalent human papillomavirus (qHPV) vaccine, CERVAVAC, developed by the Serum Institute of India, has received prequalification from the World Health Organization (WHO).

 

The milestone paves the way for global procurement of the vaccine. This is the 32nd WHO prequalification for products and biologicals received by the Serum Institute of India.

 

A recombinant quadrivalent HPV vaccine, CERVAVAC targets HPV types 6, 11, 16 and 18 and is indicated for both girls and boys aged 9 to 26 years.

 

Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “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”

 

CERVAVAC had previously received approval for use in India from the Drugs Controller General of India (DCGI). The vaccine is administered to prevent diseases caused by the four targeted HPV types.

 

Its indicated uses include prevention of cervical, vulvar, vaginal and anal cancers in girls and young women, as well as anal cancer in boys and young men. The vaccine is also indicated for the prevention of genital warts in the specified population.

 

With WHO prequalification now in place, CERVAVAC moves beyond its domestic approval and gains a pathway toward procurement through UN agencies, potentially supporting wider HPV immunisation efforts globally.