Serum Institute of India (SII) has applied to the country’s drug regulator seeking market authorisation to manufacture indigenously developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, official sources said on Wednesday. The Pune-based firm has applied for market authorisation after completing the phase 2/3 clinical trial with support of the Department of Biotechnology to ensure its early availability in the country, they said.
In the application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, director (government and regulatory affairs) at SII, said the vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1000 times higher than the baseline against all targeted HPV types and in all dose and age groups. The SII is also learnt to have made a presentation before the working group of HPV under the chairmanship of Dr NK Arora constituted separately by the NTAGI to review the data and usefulness of this vaccine on Wednesday, the sources said. 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. 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 said in the application. ”Like many other indigenous life-saving vaccines, we are committed to make our country ’ATMANIRBHAR’ for India’s first indigenous life-saving qHPV vaccine also. This will fulfill the dream of our hon’ble Prime Minister Narendra Modi ’VOCAL FOR LOCAL’ and ’MAKING IN INDIA FOR THE WORLD’ and will ensure prevention of cancers caused by Human Papillomavirus (Type 6, 11, 16 & 18) vaccine recombinant,” Singh is learnt to have said in the application.
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