WHO Prequalifies CERVAVAC: India's Own HPV Vaccine Cleared for Global Supply
The World Health Organization (WHO) has added CERVAVAC, the HPV (Human Papillomavirus) vaccine made by the Serum Institute of India (SII), Pune, to its list of prequalified vaccines. The news was announced on 5 October 2026; WHO's listing shows it effective from 25 September 2026.
CERVAVAC is a quadrivalent vaccine, which means it protects against four HPV types: 6, 11, 16 and 18. Types 16 and 18 cause most cervical cancers; types 6 and 11 cause genital warts.
Prequalification makes CERVAVAC eligible to be bought by UN agencies such as UNICEF and by Gavi-supported countries. This can increase global supply of a low-cost HPV vaccine.
CERVAVAC is approved for people aged 9 to 26. It is SII's 32nd WHO-prequalified product. It was developed with support from the Department of Biotechnology (DBT), BIRAC, WHO's International Agency for Research on Cancer (IARC) and the Gates Foundation.
India's national HPV drive for 14-year-old girls, launched on 28 February 2026, currently uses the imported Gardasil-4 vaccine. The prequalification strengthens the case for using the Indian-made vaccine at home and abroad.
Human Papillomavirus (HPV) and Cervical Cancer
Human Papillomavirus (HPV) is a very common virus that spreads through close skin-to-skin and sexual contact. Most infections clear on their own within a year or two. But a few "high-risk" types can stay in the body for years and slowly change normal cells of the cervix (the lower part of the womb) into cancer. Cervical cancer is almost fully preventable through vaccination before exposure and through regular screening.
CERVAVAC targets the same four HPV types as Gardasil-4. Its WHO prequalification means an Indian-made, lower-cost option can now be supplied through UN agencies, which helps the global push towards the 90% vaccination target.
WHO Prequalification Programme
WHO prequalification is a quality check by the World Health Organization on vaccines, medicines and diagnostic tests. A product that passes is placed on WHO's official list, which tells UN agencies and many low- and middle-income countries that it is safe, effective and of good quality. Most UN purchases of vaccines are made only from this list.
With prequalification, CERVAVAC can now be bought by UNICEF and Gavi for national HPV programmes in other countries. It also adds to India's reputation as a large, trusted vaccine supplier.
Universal Immunisation Programme (UIP)
The Universal Immunisation Programme (UIP) is the Government of India's free vaccination programme for children and pregnant women. Through it, every newborn in India can get free vaccines at government health centres against 12 vaccine-preventable diseases. It is one of the largest public health programmes in the world, reaching about 2.6 crore newborns and about 2.9 crore pregnant women every year. It is run by the Ministry of Health and Family Welfare (MoHFW).
India's HPV drive is the newest addition to its immunisation effort, and it currently uses an imported vaccine. WHO prequalification of the Indian-made CERVAVAC strengthens the case for a cheaper, home-grown HPV vaccine being used more widely in India's programme and supplied to other countries.
- Vaccine: CERVAVAC, by Serum Institute of India, Pune
- Type: recombinant quadrivalent HPV vaccine (types 6, 11, 16, 18)
- WHO prequalification: announced 5 October 2026; effective 25 September 2026
- Age group: 9 to 26 years; 2 doses for ages 9 to 14, 3 doses for ages 15 to 26
- SII's 32nd WHO-prequalified product
- Development partners: DBT, BIRAC, IARC (WHO), Gates Foundation
- India's national HPV drive: launched 28 February 2026 (Ajmer, Rajasthan); single dose of Gardasil-4 for about 1.15 crore girls aged 14
- WHO 90-70-90 targets for 2030; elimination threshold: fewer than 4 cases per 1,00,000 women