New Delhi: The DCGI’s Subject Expert Committee on Wednesday recommends Serum Institute’s indigenously developed quadrivalent human papillomavirus (qHPV) vaccine for cervical cancer patients above 9 years to 26 years of age.
Prakash Kumar Singh, director (government and regulatory affairs) at SII had applied to Drugs Controller General of India (DCGI) on June 8 for market authorisation of qHPV after completing the phase 2/3 clinical trial with support of the Department of Biotechnology to ensure its early availability in the country.
“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 told news agency PTI.
DCGI's Subject Expert Committee recommends Serum Institute's indigenously developed quadrivalent human papillomavirus (qHPV) vaccine for cervical cancer patients above 9 years to 26 years of age – both male and female pic.twitter.com/PQ9zf4f80G
— ANI (@ANI) June 15, 2022
In the application to the DCGI, Singh is learnt to have 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.
The Serum Institute 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 had mentioned that lakhs of women are diagnosed every year 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.
(With inputs from PTI)
