First made-in-India qHPV vaccine against cervical cancer in women gets DCGI's approval
Cervical cancers is the second most frequent cancer among women between 15 and 44 years of age with a high death ratio in India. At such a time, 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.
The revolutionary step for the Indian demography will now help prevent cases of cervical cancer. DCGI's approval comes following recommendation by the Subject Expert Committee (SEC) on Covid-19 of the CDSCO on June 15 over the same.
CEO and Owner of Serum Institute of India, Adar Ponawalla later took to twitter to make the announcement and 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."
The government advisory panel NTAGI had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.
SII's director of government and regulatory Affairs Prakash Kumar Singh on 8 June applied to the Drugs Controller General of India for market authorisation of the qHPV vaccine after the phase 2/3 clinical trial was completed with the support of the Department of Biotechnology.
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.
"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.
The application mentioned that lakhs of women are diagnosed every year with cervical and a few other types of cancer and the death ratio is very high. Every year, 122,844 women are diagnosed with cervical cancer and 67,477 die from the disease.