By PTI
NEW DELHI: The government advisory panel NTAGI is likely to review on June 28 trial data on India’s first quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer, developed by the Serum Institute, official sources said on Sunday.
A separate HPV working group of the National Technical Advisory Group on Immunisation (NTAGI) had examined on June 8 the clinical trial data and usefulness of the vaccine for inclusion in the national immunisation programme, they said.
In the meantime, Serum Institute of India (SII) Director for Government and Regulatory Affairs Prakash Kumar Singh applied to the Drugs Controller General of India (DCGI) seeking market authorisation for the vaccine after the phase 2/3 clinical trial was completed with the support of the Department of Biotechnology to ensure its early availability in the country.
According to official sources, based on this application, the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended on June 15 granting market authorisation to the jab.
The approval of the DCGI is still awaited.
According to the application submitted by Singh, the 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 doses and age groups.
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.
“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 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.
