: Presence of persistent high-risk type of Cervical cancer is preventable and curable if detected early.
at an early stage, it is found to have over Cervical cancer c an be prevented through HPV vaccination of girls.
● The vaccine against cervical cancer is only the second rDNA vaccine in the world using the techniques of the early 1970s○ First being the vaccine against Hepatitis-B.
○ The expiry of key patents of the HPV vaccine was recently reported by the WHO.
Reasons for affordable vaccine development in India:● Indian industry is well equipped infrastructurally to make rDNA products at scale, particularly vaccines.
Prelims: Current events of national importance, cervical cancer, Government policies, universal immunization programme, Human Papillomavirus (HPV), Cervavac etc
Current events of national importance, cervical cancer, Government policies, universal immunization programme, Human Papillomavirus (HPV), etc Mains GS Paper II: Government policies and interventions for development in various sectors and issues arising out of their design and implementations etc
ARTICLE HIGHLIGHTS
The Population Based Cancer Registries (PBCR) of India and the International Agency for Research on Cancer (IARC) h ave acknowledged the declining trends of cervical cancer prevalence in India and the globe.
of India and the ave acknowledged the of prevalence in India and the globe. March 4 is observed as International HPV Awareness Day.
INSIGHTS ON THE ISSUE
Context
Cervical cancer:
Cervical cancer
It is the second-most common cancer among women in India, mostly affecting the middle-aged.
among women in India, mostly affecting the middle-aged. With 1,23,907 new cases and 77,348 deaths in the year 2022, India contributed to one-fifth of the global
in the year 2022, India contributed to Main cause : Presence of persistent high-risk type of Human Papilloma Virus (HPV) infection co-factors like low socioeconomic conditions, low immunity status, other genital infections, smoking etc, that facilitate initiation and progression to cancer.
: Presence of persistent high-risk type of Cervical cancer is preventable and curable if detected early.
and curable if detected early. Most cervical cancer and precancer cases can be detected in the reproductive age group.
cases can be detected in the reproductive age group. Cervical cancer has a long pre-invasive phase that lasts for 10–15 years. This provides a window of opportunity to detect and treat the neoplasia in pre-invasive stages
has a long that lasts for Cervical cancer is detected and managed at an early stage, it is found to have over 93 percent cure rate.
at an early stage, it is found to have over Cervical cancer c an be prevented through HPV vaccination of girls.
an be prevented through It is the fourth most common cancer amon g women worldwide
g women worldwide cervical cancer claims the lives of more than 3,00,000 women every year, or one life every two minutes.
women every year, or one life every two minutes. Nine out of 10 women dying of cervical cancer live in lower- and middle-income countries.
Impact of overzealous push for ‘universal’ vaccination of girls against HPV:
Selective vaccination of high-risk groups, considering its sexual transmission, unlike air-borne, water-borne or contagious diseases.
considering its sexual transmission, unlike air-borne, water-borne or contagious diseases. Targeting pre-puberty girls for this vaccine is that teenage girls indulging in promiscuous physical relations and becoming carriers of the virus are a huge risk factor for the entire adult population.
The path of vaccine manufacture in India and globally:
● The Serum Institute of India (SII) developed ‘Cervavac’ and promoted it as an indigenous and affordable vaccine.
● Cervavac uses similar techniques, deploying virus-like particles (VLPs) produced using recombinant deoxyribonucleic acid (rDNA) techniques to generate an immune response against HPV infections.
● The vaccine against cervical cancer is only the second rDNA vaccine in the world using the techniques of the early 1970s
○ First being the vaccine against Hepatitis-B.
● Prior to the development of rDNA methods, vaccine manufacture was
○ charitable or public sector enterprise with universal sharing of strains/techniques
● Amendment of the U.S. Patent Act in the 1980s allowing the patenting of genetically modified organisms (GMOs) and life processes.
● The Bayh-Dole Act legalizes publicly funded scientists setting up companies.
● Globalization of U.S. patent laws through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, vaccine development and innovation changed drastically.
● Legalization of the conversion of public ‘research’ into private ‘development’ and its monopolization by patenting.
○ The vaccine development and production was aided by the politics of liberalization and globalization.
Impact on India:
● Indian Patent Act (1970) abolished patenting products and allowed only processes, that too excluding agricultural and biological patents.
○ This enabled the growth of domestic industries to become the pharmacy of the world within two decades.
● India manufactured low-cost generic drugs and vaccines, often within a couple of years after they were introduced in the global north.
● The first rDNA vaccine produced in India for hepatitis-B entered the market within five years under the process patent and dropped the price to an order of magnitude cheaper than in the global north.
● Under the current product patent regime, a locally made DNA vaccine against cervical cancer had to wait for two decades till the expiry of the product patents before its indigenous ‘generic’ version was made available.
○ The expiry of key patents of the HPV vaccine was recently reported by the WHO.
● Prior to the domestically manufactured vaccine, two prominent multinational vaccines (Gardasil and Cervarix) were sold in India for ₹4,000 a dose.
Reasons for affordable vaccine development in India:
● Indian industry is well equipped infrastructurally to make rDNA products at scale, particularly vaccines.
● Cervavac development was funded heavily, which included nearly $7 million by the Bill & Melinda Gates Foundation (BMGF) under its Grand Challenges Fund.
● The infrastructure used in producing Cervavac was part of the production facility for the Covishield vaccine, built with significant support from the Indian government’s Department of Biotechnology.
● The shared use of resources reduced the actual input costs to enable more affordable pricing, thus raising doubts on the pricing strategy of the SII.
HPV vaccine:(Cervavac)
It is a quadrivalent vaccine, developed by the Serum Institute of India.
developed by the Serum Institute of India. It prevents the entry of four of the most common types of HPV 16, 18, 6 and 11 t hereby preventing infections, genital warts, and eventually cancer.
of hereby preventing infections, genital warts, and eventually cancer. It will be used in the government campaign.
The vaccine has to be administered in adolescent girls before they are sexually active.
Way Forward.
The unavailability of other competing vaccines from domestic players, put downward pressure on the current price of Cervavac .
put downward pressure on the current price of . The Cervavac vaccine is currently recommended universally under the government vaccination programme for girls between the ages of 9-26 at a price of ₹500 for two doses, which is expensive even for the government.
under the government vaccination programme for girls between the ages of which is expensive even for the government. For those who are left out of the government coverage, the retail price of Cervavac will shoot up four-fold to ₹2,000, in a country that has low insurance penetration and catastrophically huge out-of-pocket health expenditures.
the retail price of Cervavac will shoot up four-fold to that has low insurance penetration and catastrophically huge out-of-pocket health expenditures. The need for universal HPV vaccination to prevent cervical cancer remains an unresolved doubt, the lack of competition and opaque pricing merits investigation in the larger public interest.
prevent cervical cancer remains an unresolved doubt, the lack of competition and opaque pricing merits investigation in the larger public interest. This safe and effective vaccine can help prevent six HPV cancers. Five of these occur in women: vulvar, anal, vaginal, throat, and cervical.
six HPV cancers. Physicians are the most respected leaders in society and the trusted source for health-related information. Their leadership is needed to eliminate cervical cancer in India.
QUESTION FOR PRACTICE
Critically examine the role of WHO in providing global health security during the COVID-19 Pandemic.(UPSC 2020)
Editorial Analysis – 9 July 2024 [PDF]
