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In India, about 160 million women aged 30-59 years are at risk of developing cervical cancer, and 122,000 new cases are diagnosed annually with 67,800 deaths [1].
India also ranks among the top two countries globally on mortality for key women-specific cancers. It results in the loss of economic resources and opportunities for patients, families, employers, and society overall and sometimes the treatments might force the patients to insolvency.
1. Introduction
Cervical cancer is a type of cancer that occurs in the cells of the cervix — the lower part of the uterus that connects to the vagina. 70% of the cervical cancer cases are caused by two specific strains of the Human Papilloma Virus (HPV) - HPV 16 and HPV 18. Most human beings are exposed to HPV at some point in their life after becoming sexually active, but it manifests as cancer only in a few. Early-stage cervical cancer generally produces no signs or symptoms. However, in advanced stages the symptoms include vaginal bleeding after intercourse, between periods or after menopause, among many others - which are often confused with symptoms of other diseases.
Moreover, it is a huge economic burden on patients who suffer from the disease. A study in the Asian Pacific Journal of Cancer Prevention, concluded that the out of pocket expenditure (OOPE) in India for cervical cancer in India was high and imposes extreme financial hardship for the poor. The study pegged the health system cost for different cervical cancer treatments from USD 291 to 617. Furthermore, patients spend USD 60-350 as OOPE. These figures can be benchmarked with salaries of lower and middle income groups in India which is USD 1026 -4000 per annum.
In 2019, a Lancet study found that, between 2020 and 2069, failure to expand HPV immunization will result in 44.4 million cervical cancer diagnoses worldwide. The majority of these will be in low and middle-income countries like India. Despite this, the HPV vaccine has not been nationally introduced in India. Cervical cancer is the only cancer preventable by vaccine.
This report attempts to understand the barriers to introduction of HPV and provide useful recommendations on the areas that demand attention. It also leverages relevant learning’s from experiences of countries which have achieved better success in managing the disease burden.
In addition to this, we also conducted a survey to understand the perceptions of cervical cancer awareness and prevention in India. The sample size of the population was 438, and a pre-tested questionnaire was administered to them.
The respondents were women predominantly aged 18-25 (73.6%) and 26-35 (18.5%), with 79% from Tier-I and Tier-II cities, and 92% having completed at least graduation. 86% of the respondents were unmarried, with most of them being students (45%) or employed (49%).
Source : Literature review
2. Vaccine Adoption Barriers
a) Awareness
Spreading awareness can promote behavioral changes and increase adoption rates for vaccines. Recommendation from a healthcare provider is one of the most important drivers for parents to vaccinate their child. HPV vaccine is recommended to be taken between ages 9 - 25, before one becomes sexually active. Most vaccines are taken in childhood and adolescents rarely make wellness visits to doctors, hence, recommendation by healthcare providers has been low.
Mass media campaigns also play a key role in educating masses about diseases and their prevention. To mention a few successful campaigns, Pulse Polio with slogan “do boond zindagi ki”, tuberculosis-free India campaign “TB Harega toh India jeetega”. But, efforts in creating awareness for cervical cancer, screening and HPV vaccination through mass campaigns have been meagre.
In India, where sex remains a taboo, adolescent sex-education imparted in most of the schools in India doesn’t give students enough understanding on sexual health, including STDs.
Besides this, there is also lack of quality data on the burden of cervical cancer, economic impact of the disease and assessment of the importance and impact of the disease. In fact, 51% of the survey respondents had never heard of HPV shot for cervical cancer and 94% of survey respondents (who had heard of cervical cancer) had never undergone screening for cervical cancer. This was despite the fact that 62% and 17% of the respondents were from Tier-I and Tier-II cities respectively. Most respondents (63%) cited the internet as the primary source of information about cervical cancer, while only 34% cited a doctor or health professional, and 8.6% cited government campaigns. This signals the need for more awareness campaigns by the government, and healthcare community.
b) Acceptability
Women’s health is a low priority issue in majority of households in India, with situations being worse in rural households. Hence, cervical cancer prevention has not received due consideration. Twelve years since the HPV vaccine trials conducted in 2009 by the American non-profit PATH, India has not yet included the vaccine into its Universal Immunisation Plan. The vaccine’s inclusion would not only ensure its free supply in the public health domain, but also give a push towards nationwide acceptability.
Moreover, HPV vaccine seems to be associated with the onset of sexual activity for adolescents; hence, some parents are apprehensive of getting adolescent girls immunized. A renowned political and cultural organization also resisted efforts of including the HPV vaccine in the National Immunization Programme.
There are concerns over the safety of the HPV vaccine as well, because of the clinical trials held over a decade before in Gujarat and Andhra Pradesh, which came under scrutiny due to the death of 6 girls from the vaccinated population. Later, a government enquiry concluded that the vaccines didn’t cause the deaths, although a Standing committee concluded that ethical norms were violated.
Also, the first dose of HPV vaccine was administered in 2006, which indicates that it is a recent development. Although the vaccine has high efficacy, 80% of cervical cancers are found to be preventable with the latest HPV vaccine and some sources have quoted efficacy in the early 90s too. However, there is no long term data available to prove how effective it will be in the future.
c) Affordability
The vaccines available in India are currently manufactured by GSK and Merck and are priced at USD 39 – USD 46 for a single dose. The ideal number of doses range from two to three. However, 86% of Indian households earn less than USD 138 per month, meaning that immunizing one female would cost these households a full month paycheck. The high price also limits its inclusion in UIP.
The HPV vaccine is one of the most expensive vaccines even by developed world standards. While it makes up only ~2% of the global vaccine market by volume, it accounts for ~15% of global market value (per 2019 JRF purchase data and MI4A estimates).
Besides this, only around 37% of Indians have any form of health coverage (FY2018). Majority of the preventive healthcare insurance plans do not cover the cost of HPV vaccines. This implies that most of the healthcare expense is out of pocket and typically curative expense than insurance covered preventive expense. In fact, out of the 50% of survey respondents who had heard of HPV shots, only 38% (52 out of 438) had gotten themselves vaccinated.
3. Analyzing the supply side
Global Supply
The current global demand is met by three manufacturers namely GSK, Merk and Innovax (Innovax is not approved by WHO yet). Although they have started increasing their production, it will not translate into significant increases in the available supply until 2022. This is because vaccines have lengthy manufacturing and control processes. Quality control takes a significantly long time because international standards need to be adhered to. Adding to this supply , there are three other products currently in phase III clinical development: one HPV2 vaccine from Walvax (owned by Shanghai Zerun Biotech) and two HPV4 vaccines from Serum Institute of India and China National Biotec Group. Factors which could lead to a country not being able to source required number of vaccines are explained in brief below -
Supplier’s allocation decisions and country product preferences - Supplier’s decisions on allocation of vaccines to specific countries and preference of a country for a particular vaccine depending on valency or country of origin could lead to some countries not being able to source the vaccine.
Introduction of gender-neutral programs - 33 countries and 4 territories have started vaccinating their male population as well, leading to an increased demand for the vaccine. This could lead to a shortage of supply of the vaccine for some countries.
Vaccinating MACs (multi-age cohorts comprising females of older age groups) - Vaccinating females of older age groups could lead to a sourcing problem for some countries in vaccinating the WHO recommended age group (9-15 yrs).Given the ongoing supply constraints, the Strategic Advisory Group of Experts (SAGE) on Immunization has recommended to “temporarily pause implementation of gender-neutral, older age group (>15 years) and multi-age cohort (MAC) HPV vaccination strategies until vaccine supply allows equitable access to HPV vaccine by all countries.” Delaying vaccination due to Covid-19 - Due to Covid-19, HPV vaccine schedules could be delayed and vaccine rounds could be missed. This will lead to an increased demand for vaccines later, as countries would be pacing up which could further lead to a shortage of supply. There’s no vaccine available in the market by Indian manufacturers. This is because DCVMs (Developing Country Vaccine Manufacturers) like India require access to relevant technology which can be protected by intellectual property rights.
Two recent reports have suggested that IP might be a barrier for DCVMs who are interested in developing vaccines. Several Indian manufacturers who are interested in developing HPV vaccines have concerns about potential patent impediments. Including it in the UIP will create strong incentives for the local manufacturers.
Global Demand
According to the WHO Global Market Study ,the demand for the HPV programmatic dose from the globe was ~60 M in the year 2020 which is equivalent to the estimated supply. The demand is further going to increase to ~170 M doses in 2028 but then stabilize at ~140 M doses by 2030 once Multi-Age Cohorts (MACs) are completed. In the short term, demand increases are expected to be largely driven by potential Gavi-supported MAC campaigns. In the mid-term, introductions in China and India to National Immunization Programmes (estimated for 2023 and after) are expected to drive the most significant increases in demand because they house around 36% of the world’s population. However, The SARS-Covid-19 pandemic will have an impact on the production as well as demand of the vaccine. It’s not taken into consideration in the above estimates.
4. Best Practices
The Gardasil Access Program (GAP) was implemented in seven countries which included: Bhutan, Bolivia, Cambodia, Cameroon, Haiti, Lesotho, and Nepal.
The programs used three models for vaccine delivery :
● School based model : The model used Schools to deliver vaccines
● Health Facility Model : The model used Health Facilities to deliver vaccines
● Mixed Model: The model used both Schools and Health facilities to deliver the vaccines
Health facility-based or mixed models utilized population data for the geographic area included in the campaign. School-based models based their target population calculation on the number and age of girls registered at participating schools. The Mixed models had the highest program coverage and adherence rates whereas the Health Facility model had the lowest program coverage and adherence rate. Models that included school-based vaccination were most effective at reaching girls aged 9-13 years.
Key Takeaways
The need to include basic information on cervical cancer in very plain language is very essential and helpful, as it was particularly challenging in Bolivia and Lesotho, in which local language equivalents for “cervix” do not exist.
Rwanda, became the first African country to embark on a national cervical cancer prevention plan. In a country where sex is taboo, government officials took care not to associate the vaccine with sex. Instead, they focused on cancer prevention.
Establishing a status symbol type reward for girls who complete the full vaccine course, such as a bracelet (Nepal) or T-shirt (Haiti) helped to create demand and enthusiasm for the vaccine among the girls.
Coupling HPV vaccination with other health interventions for mothers of targeted girls helped to increase vaccination and cervical cancer screening.
The key takeaway was that a vaccination and 2 lifetime screenings was the best combination to avoid maximum cases in lower-middle-income countries.
5. The Way Ahead- Recommendations
Source : Literature review, PATH
Research Methodology
The research methodology entails thinking from first principles in identifying the barriers/drivers for the delay in HPV vaccine acceptance in India. For each of the drivers identified, a hypothesis is formulated, and an attempt is made to either accept or refute the hypothesis based on secondary research and data analysis. The three main barriers to vaccine adoption identified are :-
● Lack of awareness about the disease, its transmission and existence
● Perception around the vaccine
● Challenges in making the vaccine affordable
States wise Ranking according to incidence and screening rates:
Source: NHFS-5
The screening rates of various states act as indicators, which help the government prioritize the initiation of awareness campaigns and clinical trials in the states. According to the graph, a bottom up approach should be followed, starting from Assam with lowest screening rate and moving towards Mizoram with highest screening rate.
Vaccine Supply
Inclusion of the vaccine in the country’s UIP can give a huge boost to its reach and affordability. In the below chart, we provide the example of the rotavirus vaccine, which was included into UIP in 2016. Since adequate data on the number of doses of rotavirus sourced by India post 2016 wasn’t found, estimates of coverage (number of children vaccinated) as a proxy for the former. The chart clearly shows that the number of children vaccinated shows a steady increase since 2016. Thus it can be inferred that the number of doses sourced will increase once a vaccine is included into UIP. This should be complemented with other strategies such as providing incentives to indigenous manufacturers through tax and duty breaks. India can also use its huge market size to negotiate better terms with foreign vaccine manufacturers.
Case Example: Rotavirus Vaccine Coverage- Post inclusion in
Source : WHO
Vaccine Delivery Strategies
School based outreaches have several advantages over health centres. As per the Annual Status of Education Report (ASER) Report of 2018, over 95% of the rural children in the age group of 6-14 were enrolled in schools. The overall percentage of girls (11-14 age) out of school had fallen from 10% in 2006 to 4.1% in 2018. This shows that schools in India have a high enrollment rate. Schools can be used to facilitate health education and awareness among parents and community members in addition to health centers, which can bring about long term positive behavioral changes.
In the past, HPV vaccination drives initiated on a trial basis in India in Punjab (in the districts of Mansa and Bhatinda) and Sikkim showed a high coverage rate 93-94%. This was achieved through a school based vaccination program, with high degree of coordination between the health and education departments.
Additionally, vaccinators should be trained on recognition, management, and reporting of adverse events following immunization. An information dashboard can be established to report coverage and address any adverse events following immunization.
Behavior Change and Communication Strategy
An effective communication strategy should reassure parents and other groups about the safety and efficacy of HPV vaccines. It should reach out to communities, including local health champions, religious leaders, before introducing the new vaccine, in order to address questions and concerns (e.g., fear of side effects).The level of detail presented must be appropriate for each audience: girls, parents, teachers, health workers, and the wider community. The actual wording of messages should consider the culture, language, and literacy, and ensure a call to action.
Cervical cancer being a sexually transmitted disease has an additional taboo (challenge associated with it). In Rwanda, where similar taboos surround sex, the government adopted a communication strategy emphasizing on cancer prevention, rather than highlighting it as a sexually transmitted disease. Lessons learnt from the HIV campaign that grew to be very popular can also come handy here.
Policy Advocacy
Successfully advocating to India’s Ministry of Health and Family Welfare (MoHFW) will be the stepping stone for the introduction to the Universal Immunization Programme in India. Furthermore, a coordination mechanism with the National Technical Advisory Group on Immunization (NTAGI) and key line ministries such as the Ministry of Women and Child Development (MoWCD), and Ministry of Education (MoE) will ensure coherence at the policy level.
Given finite resources and internationally accepted best practices of evidence-based policy making, policy makers will require the following information to introduce the HPV vaccine to the National Immunization Programme.
● Nationally and locally relevant information on disease burden is sufficient for a rational inclusion in the Universal Immunization Programme
● Cost effectiveness calculations and an evaluation of financial sustainability
● Architecture deployed by other countries that have already successfully introduced the HPV vaccine
Given that clinical trials on the HPV vaccine are currently banned in India, it is difficult to establish reliable evidence for the purpose of policy making. Hence, the first step would be allowing clinical trials of HPV vaccine in the country simultaneously ensuring adherence to the global standards of ethical protocols for vaccine trials.
Further, since Health is a state subject, various state governments must also be encouraged to come up with state-specific strategies to ensure maximum acceptance and coverage of the vaccine.
Financing Strategy
For a developing nation such as India, financing is arguably the biggest hurdle faced during an health program. The difference in socio-economic backgrounds of women, as well as the feasibility and sustainability issues compounds that problem. Hence it is important that a financing strategy in India be adaptive of all these areas of concern. Here are a few financing strategies that India can adopt to bolster its fight against cervical cancer.
a) International Financing
International financing strategies leverage the network and influence of global organizations like GAVI and developed nations like USA and UK to provide help to developing nations. International Finance Facility for Immunisation (IFFIm), for example, takes multi-year (usually upwards of 20 years) pledges by donor countries, which are usually developed nations, and converts them into vaccine bonds that can be bought out in the capital markets. This provides GAVI with the full capital up-front, instead of being limited by yearly tranches.
Vaccine Independence Initiative (VII) is another such example, based on the PAHO revolving fund that allows pre-delivery financing, which helps governments in vaccine funding and procurement. Another method of international financing is an Advanced Market Commitment (AMC). An AMC is a commitment made between a vaccine manufacturer and a country, that if and when a vaccine is available the country will purchase the agreed-upon number of doses and the manufacturer will provide the vaccine at an agreed-upon discounted rate. AMCs have seen adoption in Africa, especially in Rwanda and can be an effective way of bringing down immunization costs in the short term.
International financing strategies are generally more sustainable than other methods, mainly due to the ‘guarantee’ provided by international organizations like UNICEF and developed nations like the US. This in turn can help in long term planning, and provide negotiating power to developing countries through access to capital, further driving down the costs.
b) Domestic Financing
Financing for HPV vaccination in India has been a tricky task, mainly due to the vast amount of political and social barriers needed to be overcome at a central level. The acceptance and ability of a national financing strategy is strictly dependent on the central government. However, state-level authorities like state governments can take matters into their own hands. State governments like those of Delhi, Punjab and Sikkim have successfully partnered with UNICEF and other organizations to deliver free/low-cost vaccination programs to their state population.
Moreover, with the private sector in India growing in impact, mainly due to the start-up boom, new avenues have appeared for financing. For example, Aindra systems, a Bangalore based start-up has come up with a AI-based testing kit for cervical cancer that can provide significantly faster and cheaper results compared to its current counterparts. The availability of cheaper screening options can prove to be a vastly cost-effective method over the status quo. Moreover, certain NGOs are also proactively fundraising for cervical cancer screening and vaccination, like Caped. Hence, partnership with local start-ups and private organizations working towards the same cause can be effective as well.
Source: Literature review, WHO report
6. Conclusion
The C-word (Cancer) is known to send chills down everyone’s spine invoking dread, trauma and anxiety irrespective of geography, gender or socio-economic status. However, it is ironic that the high-burden of cervical cancer disease in India hardly gets any attention despite being the only cancer preventable by vaccination.
Our research identified three key barriers to vaccine adoption:
(1) Lack of awareness about the disease, its transmission and existence
(2) Negative perceptions and myths around the vaccine
(3) Challenges in making the vaccine affordable.
These have been validated by our primary research as well which highlighted that more than 50% of the respondents had never heard of the HPV shot for cervical cancer and 71% of the respondents revealing that they did not feel the need to take a vaccine because they did not know about the diseases. It is also crucial to factor in supply-side barriers that are the absence of domestic production and heavy dependence on three large global players GSK, Merc and Innovax.
Mainstreaming the seriousness of cervical cancer and the HPV vaccination requires us to take a holistic systems-thinking approach ensuring maximum convergence in efforts by different stakeholders. The overall enabling environment for the introduction of the HPV vaccination in the UIP will require effective policy advocacy and identifying champions both at the policy and community level.
Further, it is critical to integrate the supply-side with the demand side to avoid market failure. Moreover, an adaptive financing strategy leveraging on both domestic and international sources will be the key to solving for the scalability and sustainability of HPV vaccination efforts which are critical barriers in the current ecosystem.
The overarching issue of paucity of relevant and quality pan-India data on cervical cancer-its incidence, HPV vaccination coverage and screening, cost-benefit analysis and lessons learned from other countries remains a key barrier to effectively demonstrate the seriousness of the issue. This critical gap must be addressed immediately to make universal HPV vaccination a policy priority.
Michelle Obama said that “Communities and countries and ultimately the world are only as strong as the health of their women.” Women are the cornerstone of our families’ and societies’ good health. Women contribute significantly to our GDP through unpaid labor and now increasingly through paid labor. Thus, we must emphasize for more visibility and resources, coherent political and institutional leadership for women’s health, to enable us to make progress in saving the lives and improving the health of girls and women in the coming years.
Meet The Thought Leaders
Shatakshi Sharma has been a management consultant with BCG and is Co- Founder of Global Governance Initiative with national facilitation of award- Economic Times The Most Promising Women Leader Award, 2021.
Prior to graduate school at ISB, she was Strategic Advisor with the Government of India where she drove good governance initiatives. She was also felicitated with a National Young Achiever Award for Nation Building. She is a part time blogger on her famous series-MBA in 2 minutes.
Naman Shrivastava is the Co-Founder of Global Governance Initiative. He has previously worked as a Strategy Consultant in the Government of India and is working at the United Nations - Office of Internal Oversight Services. Naman is also a recipient of the prestigious Harry Ratliffe Memorial Prize - awarded by the Fletcher Alumni of Color Executive Board. He has been part of speaking engagements at International forums such as the World Economic Forum, UN South-South Cooperation etc. His experience has been at the intersection of Management Consulting, Political Consulting, and Social entrepreneurship
Anmol Verma is the Chief Mentor at GGI and Director of Growth at Proactive for her, a women’s health start-up. Before this, she worked at Arisaig Partners as an investment analyst and was a founding team member of the Arisaig Next Generation (a global impact) Fund. After graduating from SRCC in 2015, she also spent 1.5 years at BCG. Anmol is a running enthusiast, an avid reader and loves working on projects at the intersection of technology and social impact.
Meet The Authors (GGI Fellows)
Ishani Goomer is an engineering graduate from Manipal Institute of Technology and an Analyst at Talerang. She is a professional who is obsessed with creating an impact. She has had a diverse experience during her internships at Goldman Sachs, Godrej Consumer Products Limited ,Reliance Industries and Mrida Group. At college, Ishani was the TEDx sponsorship and budget manager and Core Committee President at AIESEC. From a personal standpoint, she loves doing community service and is a volunteer at several organisations like Make a Difference, Play and Shine Foundation, and Natural is Beautiful.
Niharika Srivastava is an economics graduate from Shri Ram College of Commerce and a development consultant with IPE Global. She is passionate about impact measurement and her work revolves around evaluating policies and programmes for governments and international development agencies to drive effective implementation. Harbouring a firm belief in the power of market-based solutions, she has worked in the areas of food systems, nutrition security, livelihoods and global knowledge sharing. An avid reader, she has also been a theatre actor which has helped hone her interpersonal skills.
Samuel Varkey is a 2020 Computer Science Undergraduate. He is currently an Associate Data Analyst at Symphony RetailAI. Samuel is passionate about using Analytics and Data Science to enable organizations to make data-driven decisions. Prior to this, he has interned at DRDO, in the field of Artificial Intelligence and Machine Learning. Due to his passion for non-profits, Samuel works part time for an international non-profit named IAESTE, in the capacity of a Data Analyst.
Abhay Malla is a commerce graduate from Shri Ram College of Commerce. He is currently working as a Business Analyst at MXV Consulting. As a consultant, he is always looking out to solve new business problems and create better opportunities for his clients. He has worked on a wide range of projects like private equity, sales effectiveness and strategy. In his free time, he is also an avid reader and guitarist.
Swati Sureka is a commerce graduate from Shri Ram College of Commerce and an Incoming Business Analyst at Auctus Advisors. She currently works at InMobi at the intersection of data analytics, revenue management and operations. At college, Swati was involved in multiple initiatives aimed at creating impact at the grassroots level. From a personal standpoint, she is an amateur painter, loves teaching young minds and prefers reading non-fiction.
Tania Gupta is a graduate from NIT Trichy, with a B.Tech in Instrumentation and Control. She is a measurement, monitoring and evaluation associate at Pratham Education Foundation. She works at the intersection of education, impact measurement and data science. She has previously worked as an Analyst at HSBC, in the Wealth and Personal Banking (Data and Analytics) Team and is a graduate from NIT Trichy. She is passionate about the development sector and wants to work towards raising the standard of living for all citizens. She is an avid reader and blogger in her free time.
If you are interested to apply to GGI Impact Fellowship, you can access our application link here.
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