According to reports, the topic expert committee meeting scheduled today to consider Serum Institute of India’s (SII) indigenously manufactured Quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer has recommended regular market authorization for males and females aged 9 to 26.
“The phase 3 data of vaccine was found satisfactory after which recommendations have been made,” sources from ANI reported.
According to the sources, SII’s Director of Government and Regulatory Affairs, Prakash Kumar Singh, applied to the Drugs Controller General of India on June 8 for market authorization of the qHPV vaccine.
Prakash Kumar Singh cited the vaccine’s antibody response against HPV types in all dosages and age groups in his submission to the DCGI.
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“It’s expected that vaccine will be launched in the market before 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,” said the sources.
Cervical cancer in India
In India, 122,844 women are diagnosed with cervical cancer each year, with 67,477 dying as a result of the disease.
The HPV vaccination lowers a woman’s chance of developing cervical cancer. Although men cannot acquire cervical cancer, the HPV vaccination may help prevent genital warts, penile cancer, anal cancer, and HPV transmission to sexual partners.
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