4 min readNew DelhiJul 30, 2026 10:42 AM IST
First published on: Jul 30, 2026 at 12:19 AM IST
The Delhi High Court on Wednesday refused to stay the HPV vaccination drive currently underway across India after it was informed by the Centre that out of around 55.9 lakh doses administered so far since February, only 120 cases reported adverse events following immunisation (AEFI) as on July 25.
The court, which was hearing a PIL that flagged concerns over safety of administering Merck’s HPV vaccine Gardasil, noted that there was “no instant harm”.
Out of the 120 AEFI cases, 42 were classified as “serious/severe”, but no deaths were reported, the Centre mentioned. Of the 42 AEFI cases, causality assessment has been completed in 20 cases, it said, adding that none of the AEFI cases required hospitalisation beyond a maximum of two days.
ASG Chetan Sharma, along with the Centre’s standing counsel Ashish Dixit, told a bench of Chief Justice D K Upadhyaya and Justice Tejas Karia that the overall reporting rate of AEFI cases — approximately 0.0022% of the total doses administered — “is much below the normal, even FDA-considered (benchmark) of AEFI”.
“The data which has now been given to us, suggests that there is no instant harm. There may not be long-term benefits but there is no instant harm…as of today, I do not see any reason why this vaccination should be stopped,” the court remarked.
The submission was made by the Ministry of Health and Family Welfare in response to a public interest litigation by gynecologist and obstetrician Dr Sujata Mittal and health entrepreneur Jitendra Chouksey.
The PIL relied on past reports of adverse events with the vaccine, pointing out that an earlier attempt at rolling out the HPV vaccine in 2009, with clinical trials conducted in Gujarat and Andhra Pradesh, had led to several deaths in 2010 in a village in Andhra Pradesh’s Khammam.
The government had in February rolled out the vaccination drive, offering a free single dose of quadrivalent HPV to eligible 14-year-old girls to prevent cervical cancer. Gardasil 9 vaccine provides protection against nine strains of HPV.
A 2017 report by the Global Advisory Committee on vaccine safety that broadly held the vaccine to be safe, had observed, “Despite the extensive safety data available for this vaccine, attention has continued to focus on spurious case reports and unsubstantiated allegations.”
A 2026 meta-analysis of serious adverse events (SAE) following HPV vaccination, published in the Human Vaccines and Immunotherapeutics journal, by analysing 14 studies, found that the “reporting rate of SAEs ranged from as low as 0.00 per 1,000 doses in studies that reported zero SAEs to as high as 4.53 per 1,000 doses.”
The petitioners’ lawyers on Wednesday, however, flagged that the vaccine is being administered without data on side effects in the long-term, and without informed consent. Recording the petitioners’ apprehensions raised on adverse events, efficacy and the government’s justification of administering HPV vaccination in campaign mode, the court directed the Centre to file an affidavit in response to the PIL.
The court, addressing the Centre’s counsels, also remarked orally, “The petition raises serious issues. There have been issues, violation of testing, in grant of certificate of use, when any new drug or vaccine is introduced. In our zest, sometimes we fail to follow the necessary protocol before introducing these vaccines, you cannot deny that.”
“We are not making any comment whether in this case you’ve followed the rules, protocol etc or not… but things have to be seen seriously…We are here only to ensure that necessary protocol is followed…there may be long-term effects also. A person being vaccinated today may develop something wrong in 15 years. These are some of the concerns…”
A 2017 report by the Global Advisory Committee on vaccine safety that broadly held the vaccine to be safe, had observed, “Despite the extensive safety data available for this vaccine, attention has continued to focus on spurious case reports and unsubstantiated allegations.”
Share
