The Central government’s hesitance to introduce human papillomavirus (HPV) vaccine in the Universal Immunisation Programme (UIP) despite the recommendation of a high-level technical advisory group is resulting in thousands of cervical cancer deaths every year, statistics show. While healthcare professionals and vaccine advocacy groups rap policymakers for dilly-dallying on the issue, the number of potentially preventable deaths from HPV infections is surging at a quick pace.
According to data compiled by HPV Information Centre, a collaboration of The Catalan Institute of Oncology and the International Agency for Research on Cancer, India has one of the world’s highest burdens of HPV-related cancer. Cervical cancer is the second leading cause of cancer deaths among women here. More than 122,000 Indian women are diagnosed with cervical cancer and around 67,000 die from this disease each year, more than the country’s maternal mortality burden of 45,000. The National Technical Advisory Group on Immunisation (NTAGI), an advisory body that recommends vaccines for the country’s UIP, gave the green signal for the introduction of the HPV vaccine in the programme in December last year. But the proposal is yet to see the light of day.
“In spite of multiple warnings, the government remains unconvinced and many still doubt its efficacy. There are also concerns about the high cost factor. Recent reviews of vaccines have showed that they have high efficacy. It should be part of the immunisation programme regardless of current costs,” says Dr Meenakshi Ahuja, a leading gynecologist and obstetrician and a vocal supporter of HPV vaccination.
Two kinds of cervical cancer vaccines are currently available. Cervarix, manufactured by GlaxoSmithKline, is a bivalent vaccine that protects against infection by two HPV strains – type 16 and type 18. The other vaccine is Gardasil, manufactured by Merck Sharp and Dohme (MSD), which is a quadrivalent vaccine that provides protection against four HPV strains types 16, 18, 6 and 11. Types 6 and 11 cause genital warts that are additional risk factors for cervical cancer. India approved these two vaccines in 2008 and they have been available in the market. But the vaccines are priced at around Rs 3,000 for a single dose and are not affordable for the target population.
HPV vaccines sparked a furore in India in 2008 when 8 girls died after taking part in a clinical trial conducted by an American non-profit organisation with the Andhra Pradesh and Gujarat governments. A government enquiry later concluded that the deaths were unrelated to the vaccines. The Supreme Court is currently hearing a public interest litigation filed in 2012 raising questions about this trial and the vaccine. According to the ministry of health, the decision on who will make the HPV vaccines will depend on the verdict in this case.
The World Health Organisation issued an update on HPV vaccine safety last year, recording the findings of the Global Advisory Committee on Vaccine Safety that probed adverse events. The committee found that there was no evidence to suggest an association between HPV vaccine and the neurological and chronic fatigue disorders.
Health experts say that high cost, rather than doubts about its efficacy and safety, is acting as an impediment to HPV vaccination drive in the country. From 2006 to 2014, as many as 64 countries nationally, four countries sub-nationally and 12 overseas territories implemented HPV immunisation programmes. An estimated 118 million women had been targeted through those initiatives, but only 1 per cent were from low-income or lower-middle-income countries.
The HPV vaccine will soon have an Indian manufacturer which might reduce its cost substantially. Serum Institute of India is already conducting phase-III trials. Other domestic companies are also trying to develop similar vaccines.
But it is all a matter of political will, say health professionals. Delhi and Punjab have already incorporated the HPV vaccine into their public health programmes. “Women’s health issues should get more policy attention. If a vaccine is useful, the government should find resources for the expenses. It should be part of the routine childhood immunisation programme,” said Dr Arun Wadhwa, a well-known Delhi-based paediatrician who has more than 35 years of experience in the field.
Experts are of the view that all medicines have a certain amount of risks as well as benefits and the cost of the vaccine will come down once it is included in the immunisation drive. “In the case of HPV vaccine, the benefits outweigh the risks. It can save thousands of lives,” Dr Ahuja opined.