Dear Editor, The National Technical Advisory Group on Immunization recently recommended the inclusion of the human papillomavirus (HPV) vaccine in the Universal Immunization Program for 9–14-year-old adolescent girls for the prevention of cervical cancer.1 Cervical cancer is the fourth-most common cancer among women globally, with India accounting for a quarter of the global burden.2 Even before the introduction of the HPV vaccine, the country has seen an encouraging decrease in the burden of cervical cancer over the past three decades.2 The launch of the HPV vaccine in India has been messy, marked by controversy surrounding trials conducted by The Program for Appropriate Technology in Health from 2009 to 2010.3 Multiple deaths of vulnerable girls during the clinical trials sparked public outcry and government intervention.3 A subsequent parliamentary investigation revealed irregularities, including a memorandum of understanding signed before vaccine approval, raising questions about safety and questionable promotion practices.3 Apart from this misadventure, recent scientific evidence also challenges its efficacy in preventing cervical cancer due to limitations in trial design and data analysis.4 Trials, which primarily focused on surrogate outcomes such as cervical intraepithelial neoplasia (CIN1), lacked adequate follow-up to assess hard end points, such as cervical cancer development.4 Overdiagnosis of CIN, compounded by shorter-than-recommended cytology intervals, may have inflated vaccine efficacy estimates.4 Besides, most trials predominantly included older participants instead of the target vaccination age group.4 Efficacy in younger girls was extrapolated via immunobridging trials rather than direct clinical outcomes.4 In addition, no efficacy studies have been conducted in regions like Africa, where cervical cancer rates are notably high, reflecting a gap in understanding global HPV epidemiology.4 Subgroup analyses were often underpowered and lacked clear metrics like numbers needed to vaccinate, raising concerns about false-positive results.4 Amidst these prevailing uncertainties, the introduction of the Indian-origin Cervavac vaccine, with endorsements from prominent actors and leaders, has further muddied the waters surrounding HPV vaccines.5 Besides, the product description of Cervavac, mentioning the absence of human data from clinical studies regarding its impact on fertility along with the limited study conducted using a 7-month timepoint, underscores significant unknowns regarding its long-term effects and adds to the existing concerns.5 To conclude, the available evidence does not seem to support the inclusion of the HPV vaccine as a mass vaccination strategy, which could inadvertently eliminate the crucial unvaccinated control group necessary to confirm vaccine efficacy using the hard endpoint, i.e., cervical cancer. Implementing widespread cervical screening, conducting comprehensive long-term follow-up studies on both vaccinated and unvaccinated cohorts to assess the benefits and risks of the HPV vaccine, and fostering a constructive approach to addressing vaccine hesitancy and concerns of the parents in a transparent manner, are a few critical strategies that can be implemented to resolve the dilemma. It is important to stress that the HPV vaccine is not a complete solution to cervical cancer; a comprehensive prevention strategy should also include safe sex practices, genital hygiene, regular cervical screening for older women, and offering the vaccine as a personal choice with full counseling, rather than prematurely including it in the UIP. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Ak et al. (Thu,) studied this question.
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