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A high court in India will consider a legal challenge to the national rollout of the human papillomavirus (HPV) vaccination program for adolescent girls using Merck’s Gardasil 4 vaccine, The Indian Express reported.
The Delhi High Court on Wednesday agreed to consider a Public Interest Litigation brought by multiple parties concerned about deaths that occurred during clinical trials for the HPV vaccine in the Indian states of Gujarat and Andhra Pradesh. The deaths were reported in 2010.
A Public Interest Litigation allows members of the public to ask the court to allow them to bring complaints on behalf of the “oppressed and the marginalised” who may not have the financial means to bring lawsuits themselves.
It’s not a requirement that the person filing the complaint be directly affected by the issue. Multiple people filed the complaint in the HPV case: Dr. Sujata Mittal, a gynecologist and obstetrician; Jitendra Chouksey, a health entrepreneur; and attorneys Gyanendra Kumar and Rohit Kumar.
They said they are seeking to protect the constitutional rights of young girls to personal liberty, bodily autonomy and informed consent under Articles 19 and 21 of the Indian Constitution, The Hawk reported.
In February, Prime Minister Narendra Modi kicked off the national HPV vaccination campaign targeting 150 million teenage girls.
For 90 days, government facilities across the country planned to offer a free, single dose of Merck’s Gardasil 4 vaccine to 14-year-old girls. After that, the facilities are providing the shots on routine vaccination days.
The Indian government is partnering with the Gates Foundation-backed Gavi, the Vaccine Alliance, which since 2023 has given the government hundreds of millions of dollars to add the HPV and typhoid conjugate vaccines to India’s national immunization schedule.
The Gates-backed Program for Appropriate Technology in Health (PATH) was behind the earlier clinical trial for the HPV vaccine that led to serious adverse events and reported deaths among teenage girls. A major parliamentary investigation into the deaths led to a permanent halt in the rollout of the vaccine.
The petitioners raised concerns about adverse events associated with the shots, given the earlier serious issues and the lack of access to data about adverse events associated with the ongoing rollout.
Chief Justice D.K. Upadhyaya and Justice Tejas Karia, who heard the petition, called the issue “a very serious matter.”
According to Indian Express, they said:
“You get yourself immunised not to get infected. We are not doubting your intentions, but it is a serious issue concerning all girl children, women at large … This is a very important issue … Vaccination is a good scheme, but if there are adverse events we need to be cautious.”
Counsel for the petitioners requested that data on adverse events be shared with the court. However, obtaining that data is difficult because it is not available publicly.
Kumar said there is a department that records such events. In 2013, the department reported so many adverse events associated with the HPV vaccine that the PATH project was ended.
“In 2026, the same vaccine has been launched,” Kumar said. He wondered whether “they can at least come with the data on the adverse events among the 1.15 crore [11.5 million] people who have been administered so far.”
Kumar urged the court to direct authorities to put that adverse event data into the record.
The court asked the Ministry of Health and Family Welfare, the Indian Council of Medical Research and the Central Drugs Standard Control Organisation to respond to the issues raised in the petition.
They also ordered the state to put data on adverse events into the record by next week.
The next hearing will take place on July 29, 2026.
Previous deemed ‘child abuse’ by government investigation
Beginning in 2006, PATH violated Indian laws to covertly test Gardasil and GlaxoSmithKline’s Cervarix HPV vaccine on 24,000 Indian girls ages 10 to 14.
The project was also funded by Merck and GlaxoSmithKline, and conducted in partnership with the Indian Council of Medical Research (ICMR) and the state governments where the drug was tested.
The government suspended the project in 2010 following protests over the deaths of seven girls who took the vaccine. The Parliamentary Standing Committee on Health and Family Welfare held an inquiry and published the results in 2013.
The committee found negligence among many of the institutions involved, including PATH and the ICMR. Although the sponsors called the vaccine rollout a “demonstration project,” the committee ruled that it was actually a clinical trial.
It found the project “violated all laws and regulations laid down for clinical trials by the Government. While doing so, its sole aim has been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine included in the UIP [Universal Immunization Programme] of the Country.”
There was no informed consent for the girls or their parents and no follow-up or proper reporting of adverse events and serious adverse events associated with the shot, according to the report.
The committee concluded that the trial was an “established case of child abuse” and recommended the government take action against PATH.
PATH disputed the committee’s findings. No criminal charges were ever filed.
History repeats: same vaccine, same unanswered questions
The new campaign represents a new move toward getting the HPV shot included in the Universal Immunization Programme.
An Indian version of the shot, Cervavac, is undergoing clinical trials and is expected to be considered for inclusion in the program after 2027, according to the Business Standard.
When the campaign was launched in February, Donthi Narasimha Reddy, Ph.D., visiting senior fellow at the Impact and Policy Research Institute, called for an independent scientific review of the latest HPV vaccination campaign in a March 1 letter addressed to Union Health Minister J.P. Nadda.
Reddy raised some of the same concerns that are outlined in the Public Interest Litigation, alleging there are serious and long-standing concerns in India with the HPV vaccine.
He said that in the new campaign, there is no transparency, and no clear mechanism for adverse event reporting. There are no district-level measures cited for adverse event reporting, no paper-based reporting methods for offline areas, and no mandatory public disclosure of aggregated adverse event data.
“Absence of reporting is not safety,” he wrote in his letter to the health minister.
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The Gardasil vaccine has been linked to myriad adverse events. Some of the signature injuries include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome or POTS, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome.
There have been thousands of reports of adverse events worldwide. Peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries demonstrate plausible associations between HPV vaccination and autoimmune conditions.
Merck recently settled hundreds of cases in the U.S. alleging the shot caused serious adverse events.
Gardasil sales have been in freefall — down 40% globally between 2024 and 2025, driven in part by a collapse in demand in China, then down another 22% in the first quarter of 2026, with notable declines in Japan and the U.S.
At the same time, an international campaign — funded largely by the Gates Foundation — is underway to vaccinate 86 million girls in low- and middle-income countries against HPV.
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