SEC to review Serum Institute qHPV vaccine trial data today

New Delhi: The first indigenously developed quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer by the Serum Institute of India (SII) will be discussed by the Subject expert committee on Wednesday.

The application for market authorization of the qHPV vaccine was submitted to the DCGI on June 8 by Prakash Kumar Singh (director of government and regulatory affairs).
The application to the DCGI by Singh mentions the antibody response of the vaccine against HPV types in all dose and age groups.
The vaccine is expected to be launched in the market before the end of 2022, sources told ANI. The qHPV will be India’s first indigenously curated vaccine against cervical cancer.
To ensure its early availability in the country, the Pune-based Serum Institute of India has applied for market authorization after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology.

Cervical cancer in India ranks as the second-most frequent cancer among women between 15 and 44 years of age.  Cervical cancer develops in a woman’s cervix (the entrance to the uterus from the vagina). Almost all cervical cancer cases (99%) are linked to infection with high-risk human papillomaviruses (HPV), an extremely common virus transmitted through sexual contact.  Although most infections with HPV resolve spontaneously and cause no symptoms, persistent infection can cause cervical 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.

Serum Institute of India is an Indian biotechnology and biopharmaceuticals company headquartered in Pune, India. The company was founded by Dr. Cyrus Poonawalla in 1966.

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