FIRST: Serum Institute gets DCGI nod for qHPV vaccine against cervical cancer
The National Technical Advisory Group on Immunisation (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.
New Delhi: India's first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer gets Drugs Controller General of India's (DCGI) approval for market authorisation. This vaccine will be manufactured by the Serum Institute of India (SII).
The Serum Institute of India's CEO Adar Poonawalla tweeted to make the announcement. "For the first time, there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible. We look forward to launching it later this year and we thank the DCGI, MoHFW_INDIA for granting approval today," it read.
The National Technical Advisory Group on Immunisation (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.
The Subject Expert Committee on June 15 recommended Serum Institute of India (SII)'s indigenously developed Quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer for regular market authorisation.
The phase 3 data of the vaccine was found satisfactory after which recommendations were made.
Sources close to ANI said, "It is expected that vaccine will be launched in the market before the year-end. The qHPV will be India's first indigenously vaccine against cervical cancer. The Pune-based Serum Institute of India has applied for market authorisation after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology to ensure its early availability in the country."
On June 15, the DCGI's Subject Expert Committee recommended Serum Institute's indigenously developed quadrivalent human papillomavirus (qHPV) vaccine for cervical cancer patients above 9 years to 26 years of age.
Cervical cancer is the fourth most common cancer in women. In 2018, an estimated 570 000 women were diagnosed with cervical cancer worldwide and about 311 000 women died from the disease.
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