On June 15, the subject expert committee will discuss 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 authorization application for QHPV vaccination With the Drugs Controller General of India (DCGI) on 8th June…
Singh’s application to the DCGI describes the antibody response of the vaccine against HPV types in all dosage and age groups.
According to ANI sources, the vaccine is going to hit the market by the end of 2022. The QHPV vaccine will be India’s first indigenously-curated cervical cancer vaccine.
After completing Phase 2/3 clinical trials with the help of Department of Biotechnology, Pune-based Serum Institute of India submitted it for market permission to ensure its early availability in the country.
In his application, Singh said that the vaccine CERVAVAC has demonstrated a significant antibody response against all targeted HPV types in both dosage and age ranges, which is 1,000-fold higher than baseline.
Sources said that SII had also made a presentation on Wednesday before the working group of HPV headed by Dr NK Arora, set up separately by NTAGI to review the data and usability of this vaccine.
In the application, Singh mentioned that every year lakhs of women are diagnosed with cervical cancer as well as some other cancers and the death ratio is also very high.
Cervical cancer in India is the second most common cancer among women aged 15 to 44 years.
“It is also worth mentioning that at present our country is completely dependent on foreign manufacturers for HPV vaccine. In line with the philosophy of our group and under the leadership of our CEO Dr. Adar C Poonawalla, it has always been our endeavor to provide High quality ‘Made in India’ vaccines at affordable cost to the people of our country and the world at large,” Singh said in the application.
“Like many other indigenous life saving vaccines, we are also committed to make our country ‘Atmanirbhar’ for India’s first indigenous life saving qHPV vaccine. It fulfills our honorable Prime Minister Narendra Modi’s dream of ‘Vocal for Local’. and will ensure prevention of cancer caused by ‘Making in India for the World’ and Human Papillomavirus (Type 6, 11, 16 and 18) Vaccine Recombinant,” Singh said in the application.
(with agency input)