SII's qHPV vaccine against cervical cancer approved for marketing by DCGI

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• Jul 13, 2022 | Poonam Nath

After analyzing the vaccine's clinical trial results, the government advisory council NTAGI recently authorized it.

Digital Desk: Serum Institute of India (SII) received market authorization from the Drugs Controller General of India (DCGI) on Tuesday to produce the country's first quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, according to official sources.

The approval of DCGI follows a recommendation made on June 15 by the CDSCO's Subject Expert Committee (SEC) for COVID-19. With the help of the Department of Biotechnology to assure its quick availability, Prakash Kumar Singh, director (government and regulatory relations) at Serum Institute, submitted an application to the DCGI requesting market approval of qHPV after the phase 2/3 clinical study was finished.

Following an evaluation of the clinical trial results for the vaccine, the government advisory National Technical Advisory Group on Immunisation (NTAGI) recently approved the qHPV. 

According to information obtained from sources close to Singh, in the application to the DCGI, he claimed that the qHPV vaccination CERVAVAC had shown a strong antibody response that was more than 1,000 times the baseline against all targeted HPV varieties in both dosage and age categories.

In the application, Singh stated that thousands of women are diagnosed with cervical cancer each year, along with a few other malignancies, and that the fatality rate is also quite high. In India, cervical cancer is the second most common malignancy among women between the ages of 15 and 44.

"It is also worth mentioning that our country is currently completely reliant on foreign manufacturers for the HPV vaccine." According to Singh's application, "it has always been our endeavor to make accessible high quality 'Made in India' vaccines at low prices for people of our nation and the globe at large, in keeping with our group's philosophy and under the guidance of our CEO, Dr. Adar C Poonawalla."

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