NEW DELHI: The Drugs Controller General of India (DCGI) on Tuesday granted market authorisation to the Serum Institute of India (SII) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, officials said.
Soon after the approval, SII CEO and owner Adar Poonawalla tweeted: “For the first time, there will be an Indian HPV vaccine to treat cervical cancer in women that is affordable and accessible."
“We look forward to launching it later this year,” Poonawalla tweeted as he thanked the DGCI and ministry of health for approval.
The DCGI’s approval came following a recommendation by the Subject Expert Committee (SEC) on Covid-19 of the CDSCO on June 15.
SII's director of government and regulatory Affairs, Prakash Kumar Singh, on June 8, applied to the DGCI for market authorisation of the qHPV vaccine after the phase 2/3 clinical trial was completed with the support of the Department of Biotechnology.
Cervical cancer is the second most frequent cancer among women between 15 and 44 years of age, with a high death ratio in India.
In the application to the DCGI, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated a robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.
In the application, Singh mentioned that lakhs of women are diagnosed yearly with cervical cancer and a few other cancers, and the death ratio is also very high. Every year, 122,844 women are diagnosed with cervical cancer and 67,477 die.
The government advisory panel National Technical Advisory Group on Immunisation (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.