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SII Seeks DCGI Approval for India’s First Vaccine against Cervical Cancer

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eMediNexus    09 June 2022

Serum Institute of India (SII) has applied for market authorization to manufacture India’s first Quadrivalent Human Papillomavirus (qHPV), the vaccine against cervical cancer. The Pune-based firm has applied to DCGI after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology.

In the application to DCGI, Prakash Kumar Singh, Director, SII, stated that the vaccine CERVAVAC has demonstrated robust antibody response in comparison to baseline value against all targeted HPV types in all age groups in all dosage forms. Mr. Singh also added that the vaccine will ensure the prevention of cancers caused by the Human Papillomavirus (Type 6,11,16 &18). 

Cervical cancer in India is the second most frequently diagnosed cancer among women of the age group 15-44 years. Dr. Adar Poonawalla, the CEO, of SII, stated that the vaccine will make our country fully independent from foreign manufacturers for the HPV vaccine. He also added that the vaccine is a step toward fulfilling the vision of “Make in India for the world”. 

(Source: https://health.economictimes.indiatimes.com/news/pharma/sii-seeks-from-dcgi-market-authorisation-for-indias-first-qhpv-vaccine-against-cervical-cancer/92090481 )

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