PremiumSII'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
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The National Technical Advisory Group on Immunisation (NTAGI) is likely to review on 28 June the trial data for India's first quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer, reported news agency PTI, quoting sources.
Prior to this, the subject expert committee had on 15 June reportedly recommended regular market authorisation of the vaccine – developed by the Serum Institute – for above 9 to 26-year-old males and females.
The approval of the DCGI is still awaited.
This came after 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.
According to the application submitted by Singh, the vaccine, Cervavac, has demonstrated a robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all doses and age groups.
"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 and under the 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 had said 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.
Cervical cancer in India ranks as the second most frequent cancer among women between 15 and 44 years of age. Every year, 122,844 women are diagnosed with cervical cancer and 67,477 die from the disease.
The HPV vaccine reduces a woman's risk of cervical cancer. Men cannot develop cervical cancer, but the HPV vaccine may prevent genital warts, penile cancer, anal cancer, and the spread of HPV to sexual partners.
