The Serum Institute of India (SII) was granted market authorisation by DCGI to manufacture Cervavac. This is India’s qHPV vaccine against cervical cancer.
On Tuesday, the Serum Institute of India (SII) was granted market authorisation by the Drugs Controller General of India (DCGI) to manufacture Cervavac. This is India’s first quadrivalent human papillomavirus vaccine (qHPV), and will protect women against cervical cancer.
SII CEO Adar Poonawalla tweeted that this vaccine, the first Indian-origin one for cervical cancer, will be launched later this year. “For the first time, there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible,” he tweeted.
For the first 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 #DCGI @MoHFW_INDIA for granting approval today.
— Adar Poonawalla (@adarpoonawalla) July 12, 2022
The human papillomavirus (HPV) is a common viral infection of the reproductive tract. Although most infections eventually clear up on their own, it’s a leading cause of cervical cancer. This is because all women with the infection are at risk since it might become chronic, eventually progressing to invasive cancer. While it takes around 15-20 years for cervical cancer to develop, women with weakened immune systems are at risk after five to 10 years.
Despite being largely preventable, cervical cancer is among the most common cancers in Indian women — a report on BMC Women’s Health states that the country accounts for nearly 1/3rd of global deaths caused by cervical cancer. While the HPV vaccine can prevent most cases if given to girls — aged 10 or 11 — on time, up until now, it faced a massive barrier of lack of accessibility.
What can change with the approval given to Cervavac? Here are some things to know about the new vaccine:
- SII submitted an application to the DCGI on 8 June, for permission to launch in the market. They submitted the application after completing clinical trials of Phase 2 and 3, with support from the Department of Biotechnology.
- In the application, DII director Prakash Kumar Singh said that Cervavac has demonstrated a robust antibody response, which is “nearly 1,000 times higher than the baseline against all the targeted HPV types”. This applies to all doses and age groups.
- In the application, Singh said, “It is noteworthy that presently our country is fully dependent on foreign manufacturers for the HPV vaccine. In line with the philosophy of our group & under leadership of our CEO Dr Adar C Poonawalla, it has always been our endeavour to make available high quality ‘Made in India’ vaccines at affordable prices for people of our country and world at large.”
- The vaccine includes L1 VLPs of serotypes 6, 11, 16, and 18, and is expected to give a 90 per cent coverage against the virus.
Why Serum Institute’s qHPV vaccine, India’s first against cervical cancer, is a game-changer by Firstpost, 13 July 2022
Serum Institute Seeks DCGI Nod To Manufacture QHPV Vaccine Cervavac Against Cervical Cancer by Ruchika Sharma, Medical Dialogues, 9 June 2022
Serum Institute’s Cervavac to prevent cervical cancer gets DCGI nod by Anuradha Mascarenhas, Indian Express, 13 July 2022
Serum Institute of India website
Knowledge on cervical cancer and perceived barriers to the uptake of HPV vaccination among health professionals by BMC Women’s Health, 12 February 2021
An epidemiological study of cervical and breast screening in India: district-level analysis by BMC Women’s Health, 7 October 2020
(Edited by Divya Sethu)