CERVAVAC WHO Prequalification Secured by Serum Institute

Serum Institute of India (SII) has received World Health Organisation (WHO) prequalification for CERVAVAC®, India’s first indigenously developed gender-neutral quadrivalent human papillomavirus (qHPV) vaccine. The milestone marks the company’s 32nd WHO prequalification for its products and biologicals, enabling CERVAVAC to be procured by United Nations agencies.

CERVAVAC is a recombinant quadrivalent vaccine targeting HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9–26 years, with the aim of preventing HPV-related cancers and genital warts. The vaccine was developed in collaboration with India’s Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC), alongside the WHO’s International Agency for Research on Cancer (IARC) and the Gates Foundation.

Mr. 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”

For girls and women, CERVAVAC 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 types 6 and 11. For boys and men, its indications include prevention of anal cancer associated with HPV types 16 and 18 and genital warts caused by types 6 and 11. The vaccine is administered intramuscularly, with a two-dose schedule for ages 9–14 and a three-dose schedule for ages 15–26.

Previously approved for use in India by the Drugs Controller General of India (DCGI), CERVAVAC® is administered to prevent diseases caused by the four HPV types. This includes the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It is also indicated in preventing genital warts, as applicable to the indicated population.

CERVAVAC is available in 0.5 mL single-dose vials and 1.0 mL two-dose vials. Serum Institute of India, part of the Cyrus Poonawalla Group, supplies vaccines to more than 170 countries. The company operates major manufacturing facilities in Hadapsar and Manjari, Pune, with an annual production capacity of approximately four billion doses, supporting its focus on expanding access to affordable vaccines globally.