A Locally-Made HPV Vaccine in India Faces Hesitancy and Delays

A Locally-Made HPV Vaccine in India Faces Hesitancy and Delays

September 13, 2023 by Sushmita Pathak

ON THE OUTSKIRTS of New Delhi one February morning, a childcare center in Kadipur village was transformed into a women’s health clinic. The Indian nonprofit CAPED — Cancer Awareness, Prevention and Early Detection — had borrowed the simple building, which is government-run, to host a cervical cancer screening camp.

Patients sat in too-small chairs waiting to provide their medical histories, before making their way to a closed room, where a nurse applied acetic acid solution to each patient’s cervix — the tunnel-like organ that connects the vagina and uterus — and checked for lesions. At the entrance of the camp, a large poster displayed a grave statistic in Hindi: “Every eight minutes one Indian woman dies due to cervical cancer.”

Cervical cancer is the second leading cause of cancer deaths among Indian women, with more than 77,000 dying each year, and the country accounts for 21 percent of cases worldwide. If caught early, such deaths are preventable. India’s health ministry recommends women 30 and older get screened every five years, but by one estimate, only 2 percent actually do.

There’s another way to prevent cervical cancer — by using a vaccine against the virus that largely causes it: human papillomavirus, or HPV. (There are hundreds of types of HPV; about 40 are sexually-transmitted, about a dozen of which increase the risk of cervical cancer. Not all HPV cases will lead to cancer.)

In high-income countries, HPV vaccines made by pharmaceutical giants like Merck and GSK (formerly known as GlaxoSmithKline) have brought down the disease burden. These HPV vaccines, which typically protect against a handful of viral types, are also available in India, but they’re largely inaccessible due to their high cost and they aren’t included in India’s Universal Immunization Program, through which children and pregnant women get free vaccines. Even if an HPV vaccine were included, the global supply at present would likely fall short of the demand in the world’s most populated country.

The vaccine has also faced pushback. For one, some believe, without evidence, that vaccination will lead to riskier sexual behavior among young people. And in India, there is also lingering public mistrust due to a controversial HPV vaccine study more than a decade ago.

Now, if health care workers can push through the hesitancy, a new vaccine may drastically change cervical cancer management in India and other middle and lower-income countries: Cervavac, a two-dose vaccine which was unveiled about a year ago. Developed by the Indian government and the private firm Serum Institute of India, the vaccine is manufactured domestically and promises a cheaper alternative to existing options on the market. It’s already available in private clinics in India and is set to be included in the national immunization program.

The vaccination drive is supposed to begin in a handful of states, where “girls between nine and 14 years will be given the vaccine,” said Narendra Kumar Arora, a pediatrician and member of the National Technical Advisory Group on Immunization. Simultaneously, the vaccine will also be included with other routine immunizations. “We feel that in one-and-a-half or two years the whole country will be covered up in this process.”

But for several months, experts say, the government has gone quiet. “It should definitely have been rolled out by now,” Kaushik Bharati, a public health researcher at UNESCO and an HPV vaccine specialist, of the vaccine program, wrote in an email to Undark. “So, naturally, I'm a bit disappointed.”

While the delay may be routine — government machinery is known to move at a slow pace — experts stress that the vaccine can’t come soon enough. In a statement to Undark on WhatsApp, CAPED’s CEO Mridu Gupta wrote: “Given the fact that India carries such a large burden of cervical cancer, it has taken the Gol” — or government — “of India a very long time to get proactive about prevention and control.”

Scaling up HPV vaccination has been challenging across the globe. One major reason is cost, said Partha Basu, the head of Early Detection, Prevention and Infections Branch at the World Health Organization’s International Agency for Research on Cancer — procurement and administrative expenses for two doses of HPV vaccines from manufacturers like Merck and GSK come to approximately $15 per child, whereas the combined price of procuring all the childhood vaccines in the Indian immunization program is about $13 per child. “This always puts the policymakers, ministers in a difficult situation,” he said.

The vaccine has also been in short supply. Demand shot up in recent years after the WHO recommended vaccinating not just 9-to-14 year-old girls, but also older teens. Several countries debuted the vaccine and some began inoculating boys, too, causing global demand to double between 2017 and 2018. But pharmaceutical companies weren’t able to catch up, resulting in “a crisis of supply,” said Basu. Low-income countries were left without HPV vaccines as most of the limited supply was taken by high-income countries, said Arora.

Serum’s vaccine is poised to address those issues. “For the first time there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible,” Serum’s CEO Adar C. Poonawalla said in July 2022 on X, the platform formally known as Twitter. He has also publicly said the vaccine could be priced as low as 200 rupees per dose, or about $2.50, when it is supplied to the Indian government. In comparison, HPV vaccines manufactured by other pharmaceutical firms come, at best, to $4.50 per dose when subsidized by Gavi, The Vaccine Alliance. In private clinics, Serum’s HPV vaccine sells for around $25 a shot — still relatively expensive but cheaper than others that run between about $40 to nearly $125.

With the capacity to produce 4 billion doses of various vaccines per year, the Serum Institute is the world’s largest vaccine maker by volume and Poonawalla said in 2020 that his company’s HPV vaccine production would be scaled to 100 million doses a year by 2024. Basu said he was “quite hopeful” about Serum’s HPV vaccine, that it would be significantly lower priced for India’s public vaccination program, and that the company’s “huge production capability” would “take care of the supply crisis.”

But producing enough vaccines and making them available at affordable prices is only part of the challenge. Across the world, parents have been hesitant to give their daughters an HPV vaccine out of fear that it will encourage sexual promiscuity — a stigma that is compounded in India, where sex is taboo.

At the childcare center in Kadipur, it was afternoon by the time a community health worker named Babita Chauhan arrived, along with a group of women who were coming to the camp for their cervical screenings. Workers like Chauhan were instrumental in India’s Covid-19 vaccination campaign, going door-to-door to bust myths about the vaccine and encouraging people to get inoculated. Chauhan is confident she’ll be able to convince people about the HPV vaccine’s importance, too. But there will be hiccups, just like with Covid-19, she said.

“Some people suspected that the Covid-19 vaccine was actually to stop them from having more children,” Chauhan recounted. “Many people refuse to give even routine vaccinations to their children because the kids seem healthy.”

“Then we have to go after them and explain that it’s for prevention,” she added.

A 2022 study found a lack of awareness and low confidence in the HPV vaccine even among physicians in India. Many were reluctant to recommend the vaccine because of a lack of clear, federal guidelines about age eligibility and dosage, while others doubted the vaccine’s efficacy.

Experts say that even though vaccine hesitancy is relatively low in India compared to several Western nations, including the United States, the HPV vaccine’s sexual connotation complicates things. Doctors felt uncomfortable talking to parents of adolescent girls about a sexually transmitted virus, said Ishu Kataria, a senior public health researcher at the nonprofit RTI International, who co-authored the study. Doctors reported “parents would say, ‘Are you trying to implicate that my daughter would start her sexual debut that soon? That does not happen,’” said Kataria.

“As a country, we don’t really talk about sex as a topic. Comprehensive sexual education, even at the school level, is not taught that much,” she added. Even dating, let alone sex before marriage, is frowned upon.

Experts are seeking a strong communication strategy to help the rollout’s success. “This is probably where the make or break happens,” said Kataria. The focus of the message, she said, should be on the HPV vaccine’s cancer prevention capability rather than the sexual transmission of the virus. Because India is generally a “very pro-vaccine” country, she added, if people are told that a shot can prevent cancer, which many equate with death, they will come forward. It also helps that the HPV vaccine is made in India and could instill a sense of pride among citizens, she said, just like Serum’s Covid-19 vaccine did.

In states like Punjab and Sikkim, which have held small-scale HPV immunization drives using previously available vaccines procured through Gavi, vaccinations were carried out through schools. Government and school officials also raised awareness during parent-teacher meetings.

Authorities held workshops on the vaccine for local media, too, which is crucial, said Kataria, because of previous negative coverage of the HPV vaccine. In 2009, the Seattle-based nonprofit PATH conducted HPV vaccinations in two Indian states to study its potential for inclusion in the public immunization program. But there was an outcry after seven participants died. Activists alleged that the study had been carried out on tribal children and India's parliament and media came down hard on the trial, forcing its suspension. A government committee later found minor deficiencies, but determined that the deaths were “most probably unrelated to the vaccine.” One participant, for instance, died from falling into a well and drowning, while two others likely succumbed to malaria. Nevertheless, Kataria said, it halted the progress of HPV vaccines in the country.

Advocacy groups like CAPED have their work cut out to build awareness ahead of the immunization campaign. At the screening camp, Mamta Devi was unsure whether she should get checked for cervical cancer — after all, she was hearing about it for the first time. Women exchanged questioning looks when asked if they knew what it is. One woman guessed that it affected the spine.

CAPED and others have been eager to kickstart outreach programs, waiting for months to receive official communication guidelines from the health ministry. “The current silence on the HPV vaccination program is worrying, wrote Gupta, the nonprofit’s CEO. “Clear communication is needed at this point and pre-work for uptake of vaccination needs to begin” she said, adding that “there is no initiative or interest at state-level either” because everybody is waiting for the federal government’s vaccination program.

Gupta told Undark that she is worried that the government might change its mind about HPV vaccination or could be rethinking the rollout’s coverage, which could have a “disastrous impact on the burden of the disease.”

Repeated emails to the joint commissioner of immunization at the health ministry remained unanswered. A Serum spokesperson told Undark that the company plans to produce 2 to 3 million HPV vaccine doses this year but declined to comment on the timeline of the public vaccination drive. “Serum Institute is planning to expand its production capacities, and to fulfill national needs,” wrote Madhavi Chandra, a representative from the Indian government’s Biotechnology Industry Research Assistance Council which co-developed the vaccine with Serum.

The road to scaling up HPV vaccination in India has already been very long. HPV vaccines first became available in the country in 2008. According to Chandra, work on an Indian vaccine began in 2011 but faced several delays, the pandemic being the latest. In 2017, the National Technical Advisory Group on Immunization recommended that HPV be included in the national immunization program, but vaccines for other diseases were also introduced that year, said Arora, and HPV didn’t make it.

While it’s understandable that big programs can take time, Bharati pointed out that the government has acted swiftly in the past. During the Covid-19 pandemic, India approved, manufactured, and rolled out a vaccine in months. “This shows that the government is very responsive in adverse situations, akin to ‘wartime.’ But now, it's ‘peacetime,’ so the sense of urgency has diminished,” wrote Bharati, adding that cervical cancer has been “a low priority in the health agenda.” But he added that he’s “quite optimistic” and that it isn’t a question of “if” but “when.”

Whenever the vaccine campaign launches, Arora is confident of its success. In the past India has held large vaccination drives for diseases like polio, measles and, most recently, Covid-19, during which the government vaccinated adolescents for the first time. That was not easy, admits Arora, but lessons learned back then will help with the HPV vaccination.

Even with the new vaccine, Kataria told Undark that India will have to rely on screening camps for early detection of cervical cancer among women older than 26 who aren’t recommended to get it. But screening is complicated, said Basu, because it involves not only providing tests but also managing positive cases and making sure that there is stringent quality control during testing. “If those things don't happen, screening will not work,” he said. India’s doctors also lack proper training for further investigations needed when screening turns up positive, he said. Given these impediments, he added, vaccination is “a relatively low-hanging fruit.”

Screening rates may also be low because of gender bias in health-seeking behavior, said Bharati, meaning how different genders perceive their own medical needs. Nurse Monica Chahar, who performed the acetic acid test for cervical cancer at the screening camp in Kadipur village, has seen this firsthand. When their husband or child is sick, women go running to the doctor, but when it comes to their own health, they ignore it. “That should not happen. The other family members should think about the woman,” Chahar said. “She should think about herself, too.”

It’s what Mamta Devi eventually did. After deliberating for a while, she decided to get screened. “I did so because I don’t want to fall sick later,” she said. Of the test, she added, “it felt weird,” but she’s going to tell her female friends and neighbors to get checked for cervical cancer, too.

Note: The author conducted some interviews for this story in Hindi and translated them to English.

Sushmita Pathak is a radio and print journalist who covers science, politics and culture in India. Her reporting has been published by NPR, The Christian Science Monitor, BBC Future and Wired, among other outlets.

This article was originally published on Undark. Read the original article.