Indian high court challenges national HPV vaccine rollout after prior trial deaths

• Delhi High Court intervenes in Gardasil HPV vaccine rollout, calling adverse events a very serious issue and demanding transparency.
• A petition challenges the vaccination of 150 million teenage girls, citing deaths during earlier clinical trials in Gujarat and Andhra Pradesh.
• A 2013 parliamentary inquiry found the previous trials violated laws and constituted child abuse, with seven deaths reported.
• Petitioners argue the campaign violates constitutional rights to personal liberty, bodily autonomy, and informed consent.
• Gardasil global sales have dropped sharply, yet a Gates Foundation-backed push continues amid ongoing court scrutiny.

The Delhi High Court has stepped into a growing controversy over the national rollout of Merck’s Gardasil 4 human papillomavirus vaccine, calling the matter “a very serious issue” and demanding transparency on adverse events tied to the immunization campaign. The court’s intervention comes after a Public Interest Litigation was filed by parties concerned about deaths that occurred during earlier clinical trials for the HPV vaccine in the Indian states of Gujarat and Andhra Pradesh, first reported in 2010.

The petition, brought by Dr. Sujata Mittal, a gynecologist and obstetrician, along with health entrepreneur Jitendra Chouksey and attorneys Gyanendra Kumar and Rohit Kumar, seeks 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 petitioners are challenging a campaign launched in February by Prime Minister Narendra Modi that targets 150 million teenage girls for vaccination.

Court demands answers on adverse events

Chief Justice D.K. Upadhyaya and Justice Tejas Karia, who heard the petition, were very straightforward when addressing government representatives. According to The Indian Express, they stated: “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 … Vaccination is a good scheme, but if there are adverse events we need to be cautious.”

The court ordered the Ministry of Health and Family Welfare, the Indian Council of Medical Research and the Central Drugs Standard Control Organisation to respond to the petition and place adverse-event data on record by next week, with the next hearing set for July 29. Senior Advocate Kumar told the court that no such data is publicly available, even though roughly 1.15 crore — about 11.5 million — girls have already received the shot. He noted that a 2013 parliamentary probe uncovered so many adverse events that an earlier version of the vaccine campaign was shut down entirely. “In 2026, the same vaccine has been launched,” Kumar said.

A campaign with a troubled history

That earlier campaign traces back to 2006, when the Gates Foundation-backed Program for Appropriate Technology in Health covertly tested Gardasil and GlaxoSmithKline’s Cervarix on 24,000 Indian girls without proper authorization. Seven girls died, prompting the government to suspend the trials in 2010. A 2013 parliamentary inquiry later concluded the project had “violated all laws and regulations laid down for clinical trials” and labeled it an “established case of child abuse.” No one was ever criminally charged.

Real-world harm fuels the skepticism

The concerns aren’t merely theoretical. In the U.S., attorneys have filed dozens of Gardasil-related lawsuits against Merck, including one on behalf of Catherine Boss, who was 16 when she received her first dose in 2016. She was later diagnosed with postural orthostatic tachycardia syndrome, along with dysautonomia and chronic pain — conditions that, her family says, ended her hopes of a career working with animals. Merck has already settled hundreds of similar U.S. cases.

Meanwhile, Gardasil’s global sales have dropped 40% between 2024 and 2025 and another 22% in early 2026. Yet a Gates Foundation-backed push continues to vaccinate 86 million girls across low- and middle-income countries, even as India’s own courts now insist on seeing the safety data first.

Sources for this article include:

ChildrensHealthDefense.org

IndianExpress.com

Business-Standard.com

ChildrensHealthDefense.org