PremiumOn June 15, the Subject expert committee will discuss the Serum Institute of India's (SII) first indigenously developed quadrivalent human papillomavirus (qHPV) vaccination against cervical cancer.
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On June 15, the Subject expert committee will discuss the Serum Institute of India's (SII) first indigenously designed quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer.
Prakash Kumar Singh (director of government and regulatory affairs) filed a market authorisation application for the qHPV vaccination with the Drugs Controller General of India (DCGI) on June 8..
Singh's application to the DCGI describes the vaccine's antibody response against HPV types in all doses and age groups.
According to ANI sources, the vaccine is scheduled to hit the market by the end of 2022. The qHPV vaccine will be India's first indigenously-curated cervical cancer vaccine.
After completing the phase 2/3 clinical trial with the help of the Department of Biotechnology, the Pune-based Serum Institute of India submitted for market permission to assure its early availability in the country.
In his application, Singh states that the vaccine CERVAVAC has exhibited a significant antibody response against all targeted HPV types in both dose and age categories, which is over 1,000 times higher than the baseline.
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.
(With agency inputs)