DCGI grants marketing authorisation to SII’s qHPV vaccine against cervical cancer

The Drugs Controller General of India (DCGI) on Tuesday granted market authorisation to Serum Institute of India (SII) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, official sources said.

DCGI’s approval comes following recommendation by the Subject Expert Committee (SEC) on COVID-19 of the CDSCO on June 15 over the same Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute, had applied to the DCGI seeking market authorisation of qHPV after the phase 2/3 clinical trial was completed with support of the Department of Biotechnology to ensure its early availability, official sources said.

The government advisory panel NTAGI had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.

In the application to the DCGI, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated 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 had mentioned that lakhs of women are diagnosed every year with cervical cancer as well as few other cancers and death ratio is also very high.

Cervical cancer in India ranks as the second most frequent cancer among women between 15 and 44 years of age.

“Also, it is noteworthy that presently our country is fully dependent on foreign manufacturers for the HPV vaccine. In line with the philosophy of our group & under leadership of our CEO, Dr Adar C Poonawalla, it has always been our endeavour to make available high quality ‘Made in India’ vaccines at affordable price for people of our country and world at large,” Singh mentioned in the application.