HPV transmission is influenced by sexual activity and age. File | Photo Credit: C. Venkatachalapathy

India’s first indigenously developed vaccine to prevent cervical cancer, CERVAVAC, will likely cost ₹200-400 a shot and be commercially available later this year, said Adar Poonawalla, CEO, Serum Institute of India (SII), on the sidelines of a launch event here on Thursday.

CERVAVAC, developed by SII, was approved by the Drug Controller General of India in July. The event also underlined the role of the Indian government, particularly the Department of Biotechnology, in facilitating trials and investments in the vaccine candidate.

CERVAVAC is a quadrivalent vaccine, meaning it is effective against at least four variants of cancer-causing Human Papilloma Virus (HPV), and resulted from a partnership of DBT’s Biotechnology Industry Research Assistance Council (BIRAC), and the Bill and Melinda Gates Foundation that supported Serum’s development efforts.

Annually, about 1.25 lakh women are diagnosed with cervical cancer, and over 75,000 die from the disease in India. Close to 83% of invasive cervical cancers in India and and 70% of cases worldwide are attributed to HPV-types 16 or 18.

HPV transmission is influenced by sexual activity and age. Almost 75% of all sexually active adults are likely to be infected with at least one HPV type. However, a vast majority of the infections resolve spontaneously and only a minority (<1%) of the HPV infections progress to cancer.

Though vaccines are reportedly effective in both males and females, there is a greater push to inoculate adolescent girls and women as they are more prone to contracting cancer from an HPV infection.

Besides CERVAVAC, two vaccines licensed globally are available in India; a quadrivalent vaccine (Gardasil, marketed by Merck) and a bivalent vaccine (Cervarix, marketed by Glaxo Smith Kline). Both vaccines are manufactured by recombinant DNA technology that produces non-infectious VLPs (Virus Like Particles) comprising of the HPV L1 protein.

These vaccines — though available for over a decade — are unaffordable for the vast majority of Indians and therefore CERVAVAC, say officials, is likely to be more popular because it will be around 10 times cheaper.

CERVAVAC is also made using an approach that introduces VLP to stimulate an immune response from the body resulting in production of antibodies.

“Thanks to the cooperation of government and the setting up a network to conduct trials as well as the analytical steps to test the vaccine, we were able to develop the product relatively quickly,” said Dr. Umesh Shaligram, Executive Director, SII.