Thursday, July 14, 2022

Serum Institute Gets DCGI Nod For QHPV Vaccine Against Cervical Cancer

India’s 1st Quadrivalent Human Papillimavirus vaccine (qHPV) against cervical cancer gets Drugs Controller General of India’s (DGCI) approval for market authorization. This vaccine will be manufactured by the Serum Institute of India (SII).

The SII’s CEO tweeted to make the announcement. “ For the 1st 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 DGCI, MoHFW- India for granting approval”, 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 SII ‘s indigenously developed Quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer for regular market authorization.

The phase 3 of data of the vaccine was found satisfactory after which recommendations were made.

According to sources, : It is expected that vaccine will be launched in the market before the year-end. The qHPV will be India’s 1st indigenously vaccine against cervical cancer. The Pune-based SII has applied for market authorization for completing the phase 2/3 clinical trial with the support of the Dept. of Biotechnology to ensure its early availability in the country”.

On June 15, the DCGI’s Subject Expert Committee recommended SII’s indigenously developed qHPV vaccine for cervical cancer patients above 9 years to 26 years of age.

Cervical cancer is the 4th 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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