NEW DELHI: A study by researchers from India, France and Germany has found that single-dose human papillomavirus (HPV) vaccination against cervical cancer provides lasting protection, just as the two- or three-dose regimen.
The findings of the study are likely to have major policy implications in India as the Union Ministry of Health and Family Welfare is set to introduce HPV vaccination through its Universal Immunisation Programme.
“A one-dose HPV vaccination schedule will have substantial cost saving and policy and programmatic advantages over multiple doses that will facilitate logistics of vaccine delivery, wider implementation and high coverage of target girls,” says the study, published in a recent issue of the journal Vaccine.
“One-dose vaccination is more affordable than two- or three-dose schedules, will simplify the logistics of vaccine delivery, will reduce the cost of vaccination and is particularly conducive to wider implementation in the LMICs (low and middle income countries), where four-fifths of the global burden of cervical cancer occurs.”
The study says that as studies to evaluate the efficacy of single-dose HPV vaccination demonstrate high protective effect, low-income countries without any preventive interventions against cervical cancer will be justified in initiating national HPV vaccination programmes with a single dose and could consider revising the protocol when more affordable HPV vaccines were available.
India has one of the world’s highest burdens of HPV-related cancer. Around 67,000 women die from this disease each year, more than India’s maternal mortality burden of 45,000.
In December 2017, the National Technical Advisory Group on Immunization, an advisory body that recommends vaccines for India’s UIP, approved a proposal for introduction of the vaccine, which is currently being administered only by the Punjab and Delhi governments on a pilot basis.
The decision on who will make the HPV vaccines will depend on the outcome of a 2012 Supreme Court case.
At present, two HPV vaccines are available in India, developed by Merck Sharp & Dohme and GlaxoSmithkline, while one vaccine developed by an Indian firm is in clinical trials.
A 2012 writ petition in the Supreme Court of India asks for the licences of the MSD and GSK vaccines to be revoked because they were allegedly approved by the Drug Controller General of India (DCGI) without adequate clinical trials.
That’s the reason the inclusion of the vaccine in the UIP will wait till the Supreme Court decides on the case, sources in the health ministry said.
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, went wrong.
Around 24,000 pre-adolescent girls were given MSD and GSK vaccines in the trial, overseen by the Indian Council of Medical Research and DCGI. When eight of the girls died, health activists pointed out that PATH and others had violated research ethics by giving the girls the vaccine without informed consent from their parents.