New Delhi: India may soon have its first indigenously developed human papillomavirus (HPV) vaccine that also helps prevent cervical cancer.
The Drugs Controller General of India (DCGI) on 12 July granted market authorization for the first quadrivalent Human Papillomavirus to Serum Institute of India (SII), Pune. Vaccination (QHPV) against cervical cancer.
HPV is the most common sexually transmitted infection that causes warts in different parts of the body depending on the strain. There is no cure for the infection, and warts often go away on their own.
Many people with HPV do not develop symptoms but can still infect others through sexual contact. However, HPV can Too cause cervical cancer in women,
Cervical cancer is one of main reason Female cancer mortality worldwide. Studies show that about 85 percent of cervical cancers related deaths occur in low- and middle-income countries where regular Gynecological examination is minimal or absent.
There are about 14 high-risk HPV types, including HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. HPV vaccines usually contain a protein called L1 – present on the outer surface of the virus – that is able to assemble into virus-like particles (VLPs).
These VLPs do the trick again The body thinks it is under attack from the virus, inducing immunity. to actuate the system and make antibodies.
SII is working on quadrivalent HPV vaccine which contains L1 VLP of serotypes 6,11,16,18.
The vaccine prevents infection from four strains, which according to the company, Is Be expected To give About 90 percent coverage against the prevalent papilloma virus in Developing world.
SII started Phase II/III clinical trials in 2018 at multiple centers across the country to study the efficacy of the vaccine in girls and young women, with a long-term follow-up of up to three years.
test results were reviewed By Subject Expert Committee of DCGI.
Previous attempts to introduce the HPV vaccine in India had been controversial.
In 2009, the Sith-based Organization Program for Appropriate Technology in Health (PATH) began a clinical trial with two HPV vaccines developed in the US – Gardasil and Cervarix.
In the trial, 13,000 girls aged 10 to 14 years in Andhra Pradesh were vaccinated with Gardasil and 10,000 girls in Gujarat were vaccinated with Cervarix.
However, the Indian government halted the trial in March 2010 after activist groups raised concerns over alleged safety and ethical violations following the deaths of seven girls enrolled in the study.
However, an internal government investigation concluded In 2011 that the deaths were unrelated to vaccination and did not violate any ethical norms above,