The recent launch of a nationwide vaccination programme aimed at preventing cervical cancer in teenage girls and women has been met with scepticism and doomsday predictions by a section of very vocal critics of vaccination on social media. 

The vaccine in question – Gardasil-4 – is aimed at immunising its recipients to particular strains of the human papillomavirus virus which are known to cause cervical cancer in women. As per the government, approximately 80,000 women are suspected to die because of cervical cancer in India. In many countries, where the vaccine has been administered over the last two decades, the rates of cervical cancer have reduced drastically. In some countries like Australia, vaccination is expected to wipe out cervical cancer among its female populations in a few years. 

So why then is India witnessing such scepticism and opposition to this vaccine rollout? 

A significant reason is the widely reported scandal in 2010 where the deaths of seven tribal girls were wrongly and falsely attributed to the HPV vaccines. These girls were part of a cohort of approximately 25,000 girls who received the vaccine under a study being conducted by PATH, an international NGO with a public health focus and the Indian Council for Medical Research (ICMR), which functions under the Union Ministry of Health. 

The deaths were initially raised by NGOs for women rights without any proof that the vaccine was the cause. Accusations were made by activists from All India Democratic Women’s Association (AIDWA) that Big Pharma was using the tribal girls as guinea pigs. Coincidentally, AIDWA was one amongst many activist groups which had protested the launch of the vaccine in 2009, long before the deaths came to light. Their letter to the Minister of Health, published by the IJME, is available here. The fact that the same NGOs which signed this letter were also the ones making the unsubstantiated claims that the deaths of the girls were caused by the HPV vaccines is unlikely a coincidence. 

By the time an ICMR enquiry report was made public in 2011, explaining that the deaths were not causally related to the vaccine, the damage had been done. As explained by the enquiry report, the deaths occurred due to other causes. Two deaths were attributed to suicide by consumption of an insecticide, one girl drowned, one died due to malaria and for the remaining three, the deaths were attributed to likely snakebites, viral fever or an acute (Central Nervous System) CNS illness. None of these deaths, according to the ICMR report, were attributable to the vaccine. 

On issues of consent, the enquiry report did find lapses with regard to the protocols laid down by the study; but this in itself does not appear to be an offence under Indian law. The matter did not end with the ICMR report since a parliamentary committee on health got involved and tabled a report, which castigated PATH, accusing the NGO of breaking Indian laws while conducting the study. In comments to Nature, PATH had refuted the allegations of the standing committee, stating that the committee’s conclusion was “inaccurate” in many respects. 

It is important to note at this stage that long before the HPV vaccines manufactured by Merck and GSK were rolled out in India in 2009, they had already been approved by the United States Food and Drug Administration (USFDA) in 2006. As part of its approval process, the USFDA requires rigorous safety and efficacy data from large scale clinical trials. It was and continues to be the practice of the Indian drug regulator to approve vaccines already approved by the USFDA without the requirement of repeating clinical trials. This vaccine too had already been approved by the Indian drug regulator prior to the PATH-ICMR project. 

Simply put, the vaccine was safe and effective and neither PATH nor ICMR were using an experimental, untested vaccine on the tribal girls. So, what then was the study being conducted by PATH-ICMR? 

It was described as an “observational study” by PATH-ICMR as opposed to an interventional “clinical trial” which involves far more risk to potential patients and is subject to tighter ethical norms. The aim of the study as per the ICMR enquiry study was to “evaluate strategies for delivery of the vaccine and its acceptance by the population”; it intended to collect information that could be used by the government to incorporate the vaccine into the national immunisation programme. Similar programmes had been rolled out by PATH in South America. Much of this nuance was lost in the reporting that happened around the ICMR-PATH study and many continue to link the deaths of those seven girls to the quality of the vaccine. 

The other reason driving the opposition to the HPV vaccines is the experience during the COVID-19 pandemic when the CDSCO was approving vaccines even before they could complete clinical trials. Two issues which have continued to fester are “informed consent” and compensation for injuries or deaths caused due to vaccines. Both issues are currently pending adjudication before the Supreme Court but deserve closer scrutiny. 

On “informed consent”, India does have a legal framework for participants in a clinical trial but there does not appear to be any specific statute on “informed consent” at the time of rollout of the vaccine. There is also the question of how exactly are potential recipients to be “informed” – would a simple pamphlet do or will it be necessary for them to be orally informed. These seemingly simple issues are important from a logistical standpoint in a country like ours with great variations in education, understanding and multiple languages and dialects. During COVID-19, the government never really made it a point to insist on citizens being informed of the possible, rare, side-effects of the two vaccines used in India. For example, Covishield does have some rare but deadly side-effects which can result in death but most Indians were not made aware of this risk at the time they were given the vaccine.  

Related to the issue of “informed consent” is the issue of compensation for those who have suffered due to vaccine related injuries or deaths. Unlike the United States, India currently does not have a legal framework to address this issue. Post the COVID-19 pandemic, the Kerala High Court did order the government to pay compensation to those who lost their lives due to adverse events associated with the vaccines. That case went up on appeal to the Supreme Court and a key argument made was the fact that the persons who lost their lives were never even informed of the potential side-effects. The case has been argued and judgment was reserved in November, 2025.  

Apart from the issue of compensation and “informed consent”, the Supreme Court is also expected to rule on the investigation of “Adverse events following immunisation” (AEFI). India does have in place detailed guidelines on the operation of the AEFI mechanism. But these guidelines are not binding law. Before the court, questions were raised about the transparency of India’s AEFI data during the COVID pandemic, as well as the independence of the investigation mechanism into reported adverse events. Rather than deal with these issues at a policy level through a law, the government made an ill-considered decision to litigate these issues in court. 

Unlike previous vaccination drives, the HPV vaccination drive is unfolding in a social media environment where unfiltered conversations are possible without the careful curation of expert editors. The government for its part appears to be unprepared to handle either the valid criticisms or the absurd conspiracy theories being spread on social media against the HPV vaccination drive. 

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