India’s indigenous quadrivalent Human Papillomavirus (HPV) vaccine CERVAVAC, manufactured by Serum Institute of India Pvt. Ltd., has received WHO prequalification, marking a significant milestone for India’s HPV vaccine programme and its potential global reach.
According to the World Health Organization’s official vaccine prequalification database, CERVAVAC was prequalified on 25 September 2026. The product is listed as a quadrivalent HPV vaccine manufactured by Serum Institute of India, with India’s Central Drugs Standard Control Organization (CDSCO) identified as the responsible National Regulatory Authority.
CERVAVAC is designed to provide protection against HPV types 6, 11, 16 and 18. The WHO listing includes both one-dose and two-dose vial presentations.
WHO prequalification is an important regulatory milestone for vaccines intended for use in international immunisation programmes. A vaccine that receives WHO prequalification can become eligible for procurement by UN agencies and other international procurement mechanisms, subject to applicable procurement requirements.
CERVAVAC was developed as an indigenous HPV vaccine through collaboration involving the Serum Institute of India, Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and the Bill & Melinda Gates Foundation.
The vaccine was introduced in India as part of efforts to make HPV vaccination more accessible and affordable, particularly in the context of cervical cancer prevention.
HPV infection is the major cause of cervical cancer. Expanding access to HPV vaccination is therefore an important public-health strategy for reducing the future burden of cervical cancer.
With WHO prequalification, CERVAVAC has achieved an additional international regulatory milestone that could support its availability in HPV vaccination programmes beyond India, particularly in countries that rely on WHO-prequalified vaccines for public-sector procurement.
The development is also significant for India's vaccine manufacturing sector, strengthening the country's position as a supplier of vaccines for global immunisation programmes.
