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Drugs Controller General of India's (DCGI) Subject Expert Committee on 15 June recommended granting of market authorisation to Serum Institute of India (SII) to manufacture indigenously-developed India's first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer for 9 to 26 year age group, news agency ANI reported.

Earlier on 8 June, SII's director Prakash Kumar Singh had applied to DCGI for market authorisation of qHPV after completing the phase 2/3 clinical trial. To ensure its early availability in the country, he completed the trial with support of the Department of Biotechnology.

Singh in his application 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'.

ALSO READ: SII to launch vaccine to fight cervical cancer by November

"The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application on Wednesday recommended granting market authorisation to Serum Institute to manufacture qHPV against cervical cancer," news agency PTI quoted an official source as saying.

Earlier on June 8, SII had also made a presentation before the working group of HPV constituted separately by the NTAGI to review the data and usefulness of the vaccine.

Singh mentioned in his application that lakhs of women are diagnosed every year with cervical cancer as well as few other cancers, and death ratio is also very high. In India, cervical cancer 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.

In the application, Sigh had added the 'Atmanirbhar Bharat' quotient too, claiming this as India's first indigenous life saving qHPV Vaccine. He also claimed that this vaccine will ensure prevention of cancers caused by Human Papillomavirus (Type 6, 11, 16 & 18) vaccine recombinant.

With inputs from PTI.

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