New Delhi: The Delhi High Court on Wednesday refused to halt the Centre’s HPV immunisation campaign but emphasised that “half-baked vaccines” should not be administered to the public.
A bench of Chief Justice D K Upadhyaya and Justice Tejas Karia said that the data provided by the central government regarding the administration of 5.5 million vaccines to 14-year-old girls did not indicate any “instant harm”; therefore, they saw no reason to stop the campaign.
It nonetheless asserted that the matter raised “serious issues” as there have been prior instances of violations of protocols for testing and granting certification for vaccine use.
The court said there are instances where necessary protocols are not adhered to before vaccines are put into use. While refraining from commenting on whether the rules had been followed in the present case, it stressed that the matter must be treated with due seriousness.
“Half-baked vaccines should not be administered. We are only to ensure that the necessary protocol is followed,” the court observed.
The bench was hearing a PIL seeking a direction to the authorities to reconsider and review the decision to include HPV vaccines in the Universal Immunisation Programme, citing concerns over their long-term safety, lack of informed consent and monitoring of any adverse events.
Additional Solicitor General Chetan Sharma informed the court that HPV vaccination was not part of the Universal Immunisation Programme, and that as of July 25, out of the 5.5 million vaccines administered, 120 cases reported adverse impacts, with only 42 being “slightly aggravated,” and there were zero deaths.
The law officer assured that all protocols were duly followed before introducing HPV vaccines.
Advocate Ashish Dixit also appeared for the central government.
As the counsel for the petitioner raised concerns of long-term safety of HPV vaccines and lack of informed consent, the court said it would consider the issue of “justification” for administering the vaccine and asked the Centre, Central Drugs Standard Control Organisation (CDSCO), and the Indian Council of Medical Research (ICMR) to file separate replies within four weeks.
The court acknowledged that every new drug has side effects and it is up to experts to determine whether the benefits outweigh these side effects.
“The justification to introduce the vaccine is one thing, and we will consider.. So far as your prayer for instantly stopping the administration of HPV vaccine is concerned, we are not going to stay that for two reasons. The data which is now being given to us suggests that there is no instant harm. There may not be long-term benefit, but there is no instant harm at the moment. Secondly, the apprehension that it is going to be part of the universal immunisation programme, that is not there. So let them file their reply,” the court said.
“As of today, we don’t see any reason why the administration of this vaccine should be stopped,” it added.
In a note tendered to the court, the Centre submitted that the HPV vaccination programme, which was introduced across all states and Union Territories on February 28 for girls aged 14, is voluntary and no vaccine can be administered without prior informed consent from parents.
Dr Sujata Mittal and Jitendra Chouksey have stated in their PIL that internationally, “significant safety concerns” have been raised against the ‘Gardasil’ HPV vaccine, and incidents raising questions over the vaccine’s safety have been reported in India as well.
The plea has argued that the government included the HPV vaccine in the Universal Immunisation Programme as part of a nationwide vaccination programme for young girls without considering any data on adverse consequences or ensuring parental informed consent.
According to the PIL, a 14-year-old girl from Tamil Nadu was administered the HPV vaccine at a Government Hospital in Kanai on March 30, 2026. It alleged that within three to four days, she developed severe and progressively worsening symptoms, including loss of voice, paralysis-like weakness on one side of her body, inability to walk, and blurred and diminished vision.
The plea stated that she was admitted to the ICU in a critical condition, requiring oxygen support, a catheter, and intravenous medication, and remained bedridden for several days without significant improvement. It further claimed that similar incidents reported from Gwalior and Bihar have raised serious concerns over vaccine safety and monitoring.
The plea further asserted that the long-term effectiveness of the vaccine was also “uncertain”.
The PIL has sought direction to authorities to conduct and publish district-wise and state-wise epidemiological assessments, disease burden studies, cost-effectiveness analyses and public health impact evaluations before any further expansion of the HPV vaccination programme.
The authorities should also establish an independent, transparent and publicly accessible ‘Adverse Events Following Immunisation’ monitoring and reporting mechanism, specifically for HPV vaccination, with periodic public disclosure of all reported adverse events, it said.
The matter is scheduled for the next hearing on October 29.
