The Drugs Controller General of India (DCGI) on Tuesday, 13 July, granted market authorisation to Serum Institute of India (SII) to manufacture the indigenously-developed India's first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer.
This will be India's first indigenously developed vaccine to treat cervical cancer.
Cervical cancer in India ranks as the second most frequent cancer among women between 15 and 44 years of age.
What are the specifications of the vaccine? When will it be launched? Here's all you need to know.
What exactly is Human Papillomavirus infection?
According to US Centre for Disease Control and Prevention (CDC), Human Papillomavirus (HPV) is responsible for a wide variety of genital infections. It can also lead to cancer of the cervix, vulva, vagina, or penis.
When will Serum Institute's vaccine be available in India?
The company had applied to the DCGI seeking market authorisation of the qHPV after the phase 2/3 clinical trial was completed with support of the Department of Biotechnology.
The approval by the drug regulator of SII's anti-cancer vaccine followed recommendation by the Subject Expert Committee (SEC) on COVID-19 of the CDSCO on June 15.
According to Aadar Poonawala, the vaccine will likely be available by the end of this year.
Is this the first HPV vaccine available in India?
No, this is not the first HPV vaccine to be available in India, but it is the first home-grown one.
The two HPV vaccines available in India are Ceravix, produced by GSK pharmaceuticals, and Gardasil by MSD Pharmaceuticals. Both of which cost up to Rs 4000 per dose.
How many doses does one have to take?
According to CDC:
A two-dose series (0, 6-12 months) for most persons who initiate vaccination at ages 9 through 14 years.
A three-dose series (0, 1-2, 6 months) for persons who initiate vaccination at ages 15 through 45 years, and for immunocompromised persons.
However, the Ministry of Health and Family Welfare in India is yet to release guidelines on the same.
Can I take the currently available HPV vaccine at a government hospital?
Currently, HPV vaccines are only available in private hospitals in India.
What will be the cost of SII's HPV vaccine?
There is no information on this yet. However, Poonawala has announced that the vaccine will be both accessible and affordable. Stay tuned to this space for more information.
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