This indigenously developed recombinant quadrivalent Human Papillomavirus vaccine received prequalification from the World Health Organization (WHO).
The vaccine was developed in collaboration with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), along with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation.
Mr. Adar Poonawalla, Serum Institute of India’s CEO, stated in a press release that, “WHO prequalification of CERVAVAC is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare.”
Cervavac targets four HPV types 6, 11, 16, and 18 which are responsible for causing most of the HPV-associated cancers.
Cervical, vulvar, vaginal and anal cancer are caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.
Cervavac can be administered in girls and women between 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer. It also prevents genital warts in girls and women. Cervavav is indicated for boys and men between 9 and 26 years of age for the prevention of anal cancer caused by HPV and genital warts.
Individuals between 9 and 14 years of age receive Cervavac in 2 doses. Each dose contains 0.5 mL of vaccine and is indicated at a gap of 6 months.
Whereas, individuals between 15 and 26 years of age receive 3 doses. Each dose contains 0.5 mL of vaccine. There is a gap of 2 months between the first and the second dose and a gap of 4 months between the second and the third dose.
The vaccine is administered intramuscularly. Cervavac is available in 1-dose vials of 0.5 ml and 2-dose vials of 1.0 ml presentations.
Gardasil is manufactured by MERCK, which is an American multinational pharmaceutical company, whereas Cervavac is manufactured by Serum Institute of India, an Indian pharmaceutical company.
The ongoing HPV vaccination drive in India has adopted Merck’s Gardasil 4, which protects against four HPV types, similar to Cervavac. However, India’s 2026 national HPV vaccination programme uses a single-dose Gardasil-4 schedule specifically for 14-year-old girls, while Cervavac follows a two-dose/three-dose regimen.
Additionally, the US giant shot is indicated for a broader age group from 9 to 45 years, whereas Cervavac is prescribed only for ages between 9 to 26 years.
India’s national HPV vaccination programme currently uses a single dose of Gardasil-4 for 14-year-old girls. Cervavac, meanwhile, is currently indicated as a two-dose vaccine for children aged 9–14 years and a three-dose vaccine for those aged 15–26 years.
Researchers are now studying whether one dose of Cervavac could provide a suitable option for the programme. The ongoing study is comparing single-dose Cervavac with single-dose Gardasil and could provide evidence for using Cervavac in a one-dose schedule.
Cervavac’s WHO prequalification therefore does not automatically change the vaccine used in India’s existing national programme. Its potential inclusion would depend on the evidence and subsequent programme decisions.
A WHO prequalification means that the vaccine passes the WHO quality standard for safety and efficacy. WHO prequalification involves evaluation of relevant data, testing of vaccine samples and inspection of manufacturing sites. Inclusion on the WHO List of Prequalified Vaccines means CERVAVAC can be procured by UN agencies and could facilitate access to the vaccine through international vaccination program.
Earlier, Cervavac received a green flag from the Drugs Controller General of India (DCGI) for its use in India.
(Rh/MF/MSM)
