WHO Grants Prequalification to Serum Institute's CERVAVAC HPV Vaccine

The World Health Organization has granted prequalification to CERVAVAC, the indigenously developed quadrivalent human papillomavirus vaccine from the Serum Institute of India, with the status effective from September 25, 2026. This milestone makes CERVAVAC the first Indian-made quadrivalent HPV vaccine to enter the WHO prequalified pool, enabling United Nations agencies to procure it for global immunisation programmes especially in low- and middle-income nations.

Vaccine Details

CERVAVAC is a gender-neutral vaccine licensed in India for both girls and boys aged 9 to 26 years. It targets HPV types 6, 11, 16, and 18, providing protection against high-risk strains responsible for cervical cancer as well as types causing anogenital warts. While India's ongoing national HPV programme launched on February 28, 2026, currently uses Merck's Gardasil-4 to target about 1.2 crore 14-year-old girls with free single doses—administering over 80 lakh doses by September—the new WHO status gives India a domestic option for international supply chains.

Global Impact

Globally, cervical cancer accounted for roughly 604,000 new cases and 342,000 deaths in 2020. Persistent high-risk HPV infections cause over 95% of cervical cancers, and the WHO aims to have 90% of girls fully vaccinated by age 15. Although 165 countries had introduced HPV vaccination by the end of 2025, global first-dose coverage among girls remained at only 33%.

Context

Vaccine prequalification by the WHO involves rigorous evaluation of data, sample testing, and manufacturing site inspections to ensure global standards for quality, safety, and efficacy. This status provides international purchasing agencies with the necessary assurance to distribute medicines safely across borders. While it does not automatically replace the vaccine used in India's current government rollout, it strengthens domestic manufacturing capacity and supply security for international health initiatives.