SEC to review Serum Institute qHPV vaccine trial data today

Written by Ruchika Sharma Published On 2022-06-15T11:20:38+05:30 | Updated On 15 Feb 2024 11:43 PM IST

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.

Read also: SII chief Dr Cyrus S Poonawalla conferred Dean's Medal by Johns Hopkins Bloomberg School of Public Health

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.

quadrivalent human papillomavirus vaccineqHPV vaccinecervical cancerSerum Institute of IndiaSerum Institute of India newsSIIDepartment of Biotechnology

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751