The Drugs Controller General of India (DCGI) on July 12 granted market authorisation to the Serum Institute of India (SII) for India's first indigenously-developed quadrivalent human papillomavirus vaccine (qHPV) against cervical cancer.
Cervical cancer in India ranks as the second-most frequent cancer among women between 15 and 44 years of age.
In a tweet, Adar Poonawalla, CEO of SII said, "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 @MoHFW_INDIA for granting approval today."
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 @MoHFW_INDIA for granting approval today.
— Adar Poonawalla (@adarpoonawalla) July 12, 2022
Last month, the Pune-based firm applied for market authorisation after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology to ensure its early availability in the country.
In the application to the DCGI, Prakash Kumar Singh, Director (Government and Regulatory Affairs) at SII, said the vaccine CERVAVAC has demonstrated a robust antibody response that is nearly 1000 times higher than the baseline against all targeted HPV types and in all dose and age groups.
In the application, Singh mentioned that every year lakhs of women are diagnosed with cervical cancer as well as few other cancers and death ratio is also very high.
