Serum Institute HPV Vaccine Receives Global WHO Prequalification

The World Health Organization has granted prequalification to CERVAVAC, an indigenously developed quadrivalent human papillomavirus vaccine made by the Serum Institute of India, with the status effective from September 25, 2026. This milestone marks the first time an Indian-made quadrivalent HPV vaccine has met WHO standards for quality, safety, and efficacy, enabling procurement by United Nations agencies for international immunisation programmes.

What This Means

CERVAVAC is a gender-neutral vaccine targeting HPV types 6, 11, 16, and 18, and is licensed in India for individuals aged 9 to 26 years. While high-risk types 16 and 18 account for a large proportion of cervical cancers, types 6 and 11 cause most genital warts. Globally, cervical cancer caused 604,000 new cases and 342,000 deaths in 2020. In India, the national HPV vaccination programme was launched on February 28, 2026, targeting 1.2 crore 14-year-old girls with a free single dose of Merck's Gardasil-4. Union Health Ministry data shows over 80 lakh doses had been administered by September 2026.

Context

This prequalification allows the domestic vaccine to enter international procurement channels used by low- and middle-income countries. Although it does not automatically substitute CERVAVAC into India's government immunisation programme, it adds a domestic option that could strengthen future supply security and market competition. This development follows an earlier report, covered earlier on 08 Oct 2026: 'WHO prequalifies Serum Institute of India's quadrivalent HPV vaccine, CERVAVAC | Explained'.