New Delhi: Union finance minister Nirmala Sitharaman announced in her interim budget speech last week that the government would “encourage” vaccination against human papillomavirus (HPV) that causes cervical cancer, but there is no plan to include the vaccine in the nation’s universal immunisation programme (UIP), ThePrint has learnt.
“Our government will encourage vaccination for girls in (the) age group of 9 to 14 years for the prevention of cervical cancer,” Sitharaman had said on 1 February.
Officials in the Union health ministry, however, told ThePrint that “encouragement” for the vaccination among the eligible could be in the form of promoting its usage in the private sector and, if it works out, through a price cap to make the vaccine accessible to a large number of girls — rather than through the UIP.
Under the Centre’s UIP, a number of vaccines against 12 diseases are provided free of cost to kids and a few vaccines are also offered to pregnant women.
“The Centre could also ask states to introduce HPV vaccination through the National Health Mission but an earlier plan to introduce the HPV vaccine through UIP has been scuttled as of now,” a top official in the ministry said.
In a joint letter to the states in December 2022, the health and school education secretaries had asked them to create awareness on prevention of cervical cancer and the importance of HPV vaccine among girl students across the country.
“The vaccination would be provided primarily through schools (grade-based approach: 5th-l0th) as school enrolment of girls is high,” the letter had said.
It had underlined that the National Technical Advisory Group on Immunisation (NITAG), the top advisory body on vaccination, had recommended introduction of the HPV vaccine in the UIP with a one-time catch-up for 9-14-year-old adolescent girls, and routine introduction at nine years.
But officials now maintain that the plan stays shelved. “It’s mainly due to reasons related to funds and concern around side-effects related to the vaccine,” said an official in the vaccine division of the health ministry.
ThePrint reached out to Union health secretary Apurva Chandra over call and text messages for his comments but got no response. This report will be updated if and when a reply is received.
A report released this month by the World Health Organization’s (WHO’s) International Agency for Research on Cancer (WHO-IARC) has shown that in 2022, a total of 1,27,526 women in India were diagnosed with cervical cancer while 79,906 died because of it. Globally, the country records nearly one-fifth of cervical cancer cases.
This also remains the second-largest form of cancer prevalent among Indian women, after breast cancer, and also causes the second highest number of fatalities due to cancer among women, according to the report.
HPV is the main reason behind the majority of cervical cancers — nearly 95 percent — and the US Centers for Disease Control and Prevention says that the existing vaccines against it are highly effective and their benefits far outweigh the potential risks.
According to the WHO, the primary target of vaccination is girls aged 9 to 14, prior to the start of sexual activity, but even women older than 21 years should receive the vaccine.
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‘Three routes to encourage vaccination’
Officials said the possible interventions the government could make related to facilitating the use of HPV vaccines included offering exemption on goods and services tax (GST) on the vaccines, including them in the National List of Essential Medicines (NLEM) and urging states to start their own initiatives.
“Since 2018, Sikkim has been offering school-based HPV vaccines to girls aged 9 to 13 years and the programme has turned out well — other states, too, could follow suit,” a second senior health ministry official said.
Delhi and Punjab, too, had started HPV vaccination of girls on a pilot basis in 2018 but did not include the vaccine in routine immunisation later.
The second official added that the government could even consider introducing a price cap on the existing vaccines after including them in the NLEM or refer the matter to the GST council for tax exemption.
“But the discussion on how exactly do we go ahead with expanding the vaccination coverage, without including it in the UIP, is yet to happen,” he added.
The medicines, devices and drugs included in the NLEM are called scheduled drugs and their prices are directly capped by the government.
Public health experts believe the government is dragging its feet on the initiative as it may take years for the benefits to materialise.
“If a vaccine against cervical cancer is introduced in the UIP now, it will take probably 10 years or more to show a substantial impact on cancer rates and mortality. This could be a reason why the government appears non-committal in incorporating the vaccine in its immunisation package,” said a health systems expert with a research institute in Delhi, who did not wish to be named.
Dr N.K. Arora, who heads the NTAGI, meanwhile, told ThePrint that the body has presented scientific evidence in support of introducing the HPV vaccine for eligible girls across India — but does not know what policy decision the government is taking on it.
Last month, the health ministry said in a statement that while “there have been some media reports speculating that the Union government will launch an HPV vaccination campaign in the second quarter of year 2024 to target girls in the 9-14 years’ age group, such reports are not true”.
The ministry, according to the statement, was yet to take a decision on the roll out of HPV vaccination in the country.
“It is closely monitoring the incidences of cervical cancer in the country and is in regular touch with states and various health departments regarding this,” it had said.
Inclusion in UIP necessary for wider coverage
There are three HPV vaccines currently available in India.
These include Gardasil 4 by MSD, the Indian affiliate of US pharma giant Merck, which costs Rs 3,500-4,000 per dose; and Cervarix by UK-based GlaxoSmithsKline (GSK), which costs Rs 2,200-2,600 per dose.
Since mid-2023, a third vaccine Cervavac, developed by the Serum Institute of India with support from the Centre’s department of biotechnology and which costs Rs 2,000 per dose, is also available in the country.
Another version of the Merck vaccine, Gardasil 9, which uses a different technology and is even more effective against genital warts, costs up to Rs 9,000-10,000 per dose.
Some doctors pointed out that if the vaccines stay available only privately, it will limit their access to those who might need it the most.
Dr Anadi Pachaury, consultant surgical oncologist at Manipal Hospital in Gurugram, said the majority of Indian rural population which depends predominantly on the UIP for routine immunisation may not be benefited with this approach.
In fact, said Pachaury, rural residential areas reflect poor socio-economic conditions — possibly related to lack of access to proper care which facilitates infection and persistence of HPV and an increasing risk of cancer development.
Citing a study, he said that in rural women, the rate of squamous intraepithelial lesion (SIL) — abnormal growth of squamous cells on the surface of the cervix — is 10.5 percent, while it is 4.5 percent in urban set-ups.
“Even though the government statement is reflective of its commitment against cervical cancer, including the vaccine in the national immunisation programme is one of the most effective ways towards elimination of cervical cancer,” Pachaury said.
Dr Pratima Raj, a gynaecological oncologist at Manipal Hospital in Bengaluru, too, said that for a comprehensive approach to fight cervical cancer, a combination of strategies was necessary, such as inclusion of the vaccine in the UIP and targeted efforts to improve accessibility in the private sector, alongside awareness campaigns.
But voices against the inclusion of the vaccine in the UIP have been there for years too.
Controversial vaccine
HPV vaccines have been controversial in India since 2009, when a clinical trial conducted by the American non-profit PATH, in partnership with the Andhra Pradesh and Gujarat governments, led to the death of eight girls.
Around 24,000 pre-adolescent girls were given Gardasil and Cervarix in the trial, overseen by the Indian Council of Medical Research and the Drug Controller General of India. But later, it was found that the agencies and companies involved had violated research ethics by giving the girls the vaccine without informed consent from their parents, as highlighted in a parliamentary committee report in 2013.
In 2017, Swadeshi Jagran Manch (SJM), an affiliate of the Rashtriya Swayamsevak Sangh, had written a strongly worded report to Prime Minister Narendra Modi against any efforts to introduce the HPV vaccines in the UIP, saying the project was being pushed by agencies with “vested interest”. ThePrint has a copy of the letter.
Ashwani Mahajan, national co-convener of SJM, said the group still has the same stand. “If there is a move to consider the vaccines against cervical cancer — even the one made in India — in the UIP, we will fiercely oppose it,” he said.
(Edited by Nida Fatima Siddiqui)