Pune, 12th July 2022: The Drugs Controller General of India (DCGI) today (July 12) approved the Serum Institute of India (SII) for manufacturing and marketing an Anti-cervical cancer vaccine. This will be India’s first indigenously developed Quadrivalent Human Papillomavirus Vaccine (QHPV).
The vaccine is likely to be launched later this year. Adar Poonawalla, CEO of Serum Institute of India himself gave this information.
Adar Poonawalla tweeted, “For the first time there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible. We look forward to launching it later this year and we thank the DCGI and Ministry of Health for granting approval today.”
DCGI’s approval of the HPV vaccine has come after the recommendation of the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO).
Official sources said that in collaboration with the Department of Biotechnology, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum, applied to DCGI seeking marketing approval for QHPV to ensure its early availability after the completion of Phase 2/3 clinical trial.
The National Technical Advisory Group on Immunization (NTAGI) also recently approved the vaccine after reviewing data related to clinical trials. In an application to the DCGI, Singh is understood to have said that the QHPV vaccine Cervavac has demonstrated a robust antibody response that is approximately 1,000 times more effective across all targeted HPV types and across all dosages and age groups.
In the application, Singh had pointed out that every year lakhs of women are diagnosed with cervical cancer along with some other cancers. Its mortality rate is also very high. Cervical cancer is the second most common cancer among women in the age group of 15 to 44 years in India.