India’s first indigenous HPV vaccine Cervavac gets WHO prequalification. It’s gender-neutral

Serum Institute’s gender-neutral vaccine targets HPV types linked to genital warts and cancers with the WHO nod making it eligible for procurement by UN agencies.

Serum Institute Director Prakash Kumar Singh presented the made-in-India HPV vaccine 'Cervavac' before Union Minister Jitendra Singh in New Delhi in 2023 | ANI file

New Delhi: India’s first indigenous HPV vaccine, Cervavac, received prequalification from the World Health Organisation (WHO) on Monday, making it eligible for procurement by UN agencies.

Developed by the Serum Institute of India, Cervavac is a gender-neutral vaccine that can be administered to both girls and boys. It targets four HPV types — 6, 11, 16 and 18 — and can be given to people aged nine to 26.

HPV types 6 and 11 are considered low-risk and are primarily associated with genital warts, while types 16 and 18 are high-risk strains linked to several cancers. In women, the vaccine helps prevent cervical, vulvar, vaginal and anal cancers, while in men it helps prevent anal cancer associated with HPV types 16 and 18.

The Drugs Controller General of India (DCGI) had earlier approved Cervavac for use in India. After receiving the WHO prequalification, the vaccine is now eligible for procurement by UN agencies.

According to the Serum Institute, children aged nine to 14 should receive two doses six months apart. Those aged 15 to 26 should receive three doses, with a two-month gap between the first and second doses and a six-month gap between the second and third. All three doses should be administered within a year. The vaccine is administered into a muscle and not directly into a blood vessel.

Serum Institute CEO Adar Poonawalla said in a press release that the WHO prequalification was 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,” he said.

Each 0.5ml dose of Cervavac contains proteins that help generate an immune response against the four targeted HPV types, added the release. The vaccine is produced using the Hansenula polymorpha strain.

Cervavac was developed by the Serum Institute in collaboration with the Department of Biotechnology, Biotechnology Industry Research Assistance Council (BIRAC), WHO’s International Agency for Research on Cancer (IARC) and the Gates Foundation.

(Edited by Chingkheinganbi Mayengbam)