Serum Institutes HPV Vaccine Cervavac Gains WHO Prequalification

The Serum Institute of India (SII) has announced that its Human Papillomavirus (HPV) vaccine, Cervavac, has received pre-qualification status from the World Health Organization (WHO). This recombinant quadrivalent vaccine is approved for preventing cervical, vulvar, vaginal, and anal cancers in girls and young women, as well as anal cancer in boys and young men aged 9-26. Cervavac targets four HPV genotypes, 6, 11, 16, and 18, and follows a two-dose schedule administered six months apart.

Adar Poonawalla, CEO of SII, expressed pride in the achievement, stating that WHO prequalification is a crucial step in strengthening the global response to HPV. The vaccine was developed in collaboration with the Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), the WHO-IARC, and the Gates Foundation. Clinical trials demonstrated that Cervavac has non-inferior efficacy compared to Merck’s Gardasil, which provides nearly 100% protection against the four HPV types.

The two high-risk HPV types, 16 and 18, account for over 70% of cervical cancer cases globally. WHO prequalification certifies that Cervavac is safe and effective for the intended patient population, allowing its inclusion in public health programs run by UN agencies. India’s ongoing HPV vaccination drive has been using Merck’s Gardasil 4, which protects against the same four HPV types as Cervavac but requires only a single dose. Gardasil is also indicated for a broader age range, from 9 to 45 years.