The Subject Expert Committee of the Drugs Controller General of India (DCGI) on 15 June recommended to Serum Institute of India (SII) India’s first indigenously developed quadrivalent Human Papillomavirus Vaccine (QHPV) against cervical cancer for ages 9 to 26. Recommended to give market authorization for construction. group, news agency ANI reported.
Earlier on June 8, Prakash Kumar Singh, Director, SII had applied to DCGI for market authorization of QHPV after completing Phase 2/3 clinical trials. To ensure its early availability in the country, he completed the trial in collaboration with the Department of Biotechnology.
Singh said in his application that ‘qHPV vaccine CERVAVAC has demonstrated robust antibody response that is approximately 1,000-fold higher across all targeted HPV types and across all doses and age groups’.
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News agency PTI quoted an official source as saying, “The Subject Expert Committee (SEC) on COVID-19 of CDSCO, while deliberating on the application on Wednesday, recommended Serum Institute for manufacturing of QHPV against cervical cancer. market authorization for
Earlier on June 8, SII also made a presentation to the HPV working group set up separately by NTAGI to review the vaccine data and usability.
Singh mentioned in his application that every year lakhs of women are diagnosed with cervical cancer as well as some other cancers, and the death ratio is also very high. In India, cervical cancer is the second most frequent cancer in women aged 15 to 44 years.
“It is also worth mentioning that at present our country is completely dependent on foreign manufacturers for HPV vaccine. In line with the philosophy of our group and under the leadership of our CEO Dr. Adar C Poonawalla, it has always been our endeavor to provide High quality ‘Made in India’ vaccines at affordable cost to the people of our country and the world at large,” Singh said in the application.
In the application, Singh had also added the ‘Atmanirbhar Bharat’ quotient, claiming it as India’s first indigenous life-saving QHPV vaccine. He also claimed that this vaccine will ensure the prevention of cancer caused by recombinant Human Papillomavirus (Types 6, 11, 16 and 18).
With inputs from PTI.