An expert panel of India’s central drug authority on Wednesday recommended granting market authorisation to the Serum Institute of India (SII) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, official sources said.
Prakash Kumar Singh, director (government and regulatory affairs) at SII applied to the Drugs Controller General of India (DCGI) on June 8 for market authorisation of qHPV after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology to ensure its early availability in the country.
In the application, Singh is learnt to have stated that qHPV 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 dose and age groups.
“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,” an official source said.
The SII is also learnt to have made a presentation before the working group of HPV constituted separately by the NTAGI to review the data and usefulness of this vaccine last Wednesday.
In the application, Singh mentioned that lakhs of women are diagnosed every year with cervical cancer as well as a few other cancers and the 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 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 prices for the people of our country and the 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 fulfil the dream of our Prime Minister Narendra Modi – ‘vocal for local’ and ‘Making in India for the world’ and will ensure the prevention of cancers caused by the Human Papillomavirus (Type 6, 11, 16 & 18) vaccine recombinant,” Singh is learnt to have stated in the application.