Will India-Made HPV Testing Kits Revolutionise Cervical Cancer Screening?

Cervical cancer stands as the second leading cause of cancer-related fatalities among women, claiming an estimated 70,000 lives annually, with India bearing a disproportionate burden of this preventable disease. According to GLOBOCAN, an authoritative source on global cancer statistics, India accounts for nearly 80% of cervical cancer cases in low-middle-income countries.The World Health Organization (WHO) stresses the ubiquity of this threat, citing cervical cancer as the fourth most prevalent cancer affecting women worldwide, with low- and middle-income countries bearing the brunt of its impact. Enter Cervavac, a product of a joint initiative between the Indian government and the Serum Institute of India (SII), the world's largest vaccine manufacturer by dose.

In addition to its remarkable success in vaccine manufacturing, India is on the brink of a major breakthrough in healthcare with the introduction of homegrown testing kits for the human papillomavirus (HPV). Led by AIIMS, Delhi, this pioneering endeavor signifies the inaugural validation of India-made HPV testing kits at numerous research centers worldwide, guaranteeing unmatched precision through the use of diverse global samples.

Indigenous HPV Testing Kits Set to Transform Screening Methods

Under the stewardship of Prof. Neerja Bhatla, the lead investigator of this pioneering project, a consortium of institutions including AIIMS, New Delhi, the National Institute of Cancer Prevention and Research (NICPR) in Noida, and the ICMR-National Institute for Research in Reproductive and Child Health in Mumbai, is set to embark on a comprehensive evaluation of these indigenous HPV screening test kits against international quality benchmarks.

The exorbitant cost of HPV testing has long been a barrier to comprehensive cervical cancer screening, particularly in low-middle-income countries like India. However, with the advent of indigenous testing kits, a paradigm shift is on the horizon. These homegrown solutions not only promise a significant reduction in cost but also boast enhanced accuracy, heralding a new era of accessible and reliable healthcare diagnostics.

Rigorous Validation Protocols

The validation process, supported by the Department of Biotechnology-Biotechnology Industry Research Assistance Council (DBT-BIRAC) Grand Challenges India in collaboration with the International Agency for Research on Cancer (IARC), entails meticulous scrutiny of the kits' clinical and analytical validity against stringent international standards. Dr. Bhatla stresses the complexity of this endeavor, highlighting the imperative to adhere to established criteria to mitigate the risk of false results and eliminate the margin of error.

Drawing parallels with conventional Pap smear tests, the HPV screening process involves collecting samples from the cervix using a brush or swab. However, unlike Pap smears, which rely on cytology, HPV testing adopts a molecular approach akin to COVID testing. This innovative methodology not only enhances the accuracy of detection but also streamlines the screening process, making it more accessible even in peripheral healthcare facilities.

Does A Single Shot Of Vaccine Help?

Now focusing back on the vaccine, developed locally, Cervavac stands as the first vaccine manufactured in India to receive approval from its drug controller general. This marks a departure from the limited access to HPV vaccines in the country due to their prohibitive costs from foreign pharmaceutical giants like Merck and GSK. Cervavac is a game-changer in more ways than one. Unlike its predecessors, it comes at a more affordable cost, priced at 300–400 rupees per dose.

Last month, the Indian government made a pivotal decision to include Cervavac in the country's immunization program, ensuring free distribution to girls aged nine to 14, and this week, in a groundbreaking moment at the Lalwani Mother and Child Care Hospital in Pune, India, a 14-year-old girl, Sneha Neurgaonkar, as reported by The Guardian, is about to receive the first Indian-made human papillomavirus (HPV) vaccine.

As reported by The Guardian, Adar Poonawalla, the CEO of SII, outlines an ambitious plan to manufacture 70 million doses annually, with aspirations to double this capacity by 2026. Once the demand in India is met, Poonawalla envisions exporting Cervavac to African countries, the Indian subcontinent, and possibly South America. 

A recent study by Indian scientists has revealed that a single dose of the human papillomavirus (HPV) vaccine is sufficient to prevent cervical cancer. Although the Union government had earlier dismissed news stating that the government is going to conduct a routine immunisation programme for a single-dose jab, the study in the Human Vaccines & Immunotherapeutics journal has proven that one jab is sufficient.

The study was conducted at several hospitals in India on 2,135 women over 10 years, divided into groups who received one, two, or three doses of HPV vaccines between the ages of 10 and 18. According to the report in the journal, "A high proportion of single-dose recipients still had antibody titers against HPV types 16 and 18, with the proportion being slightly higher among 10–14-year-olds than those aged 15–18."

Cervical cancer is the second most deadly cancer in women and is highly prevalent in India. It is usually caused by close contact and sexually transmitted infections due to the human papillomavirus. Owing to the highly contagious and fatal nature of the virus, doctors urge vaccination for girls and boys as well as regular screening for adults.

Speaking to SheThePeople, obstetrician-gynaecologist Dr Sharda Jain, founder of Delhi Gynaecologist Forum, pointed out that recent research shows that a single dose of the HPV vaccine can produce antibodies against cervical cancer. She pointed out that although the World Health Organisation had first urged three doses of the vaccine, people tended to avoid taking the second or third dose due to indifference.

Dr Jain said, "In 2016 WHO said two doses are required and not three. However, they found out that 87% of people, from countries that come under the immunisation program, did not take the second dose. So now the expert group, including scientists from India, have conducted extensive research and found out that one dose is good enough. WHO says that even with a single dose, the antibody titer was 15 times more than the person who has not been vaccinated. That's the beauty of it. So I see no reason why our girls and boys cannot be vaccinated."

As several people in developing countries show indifference towards committing to repeated doses of vaccines, the new study has cut down on the number of times a person needs to be jabbed. The Human Vaccines and Immunotherapeutics journal states that the research was carried out "to study the long-term antibody response after a single dose of the HPV vaccine.”

“The study showed that a single dose jab with a catch-up extended to age 20 will have a more significant impact on reducing the lifetime risk of cervical cancer and accelerating the elimination of the disease than administering two doses to pre-adolescent girls," the journal states. 

As India takes strides towards eliminating cervical cancer, the narrative not only shifts to safeguard the health of millions but also positions India as a global leader in women's health, with plans to impact lives far beyond its borders.