Delhi High Court Allows HPV Vaccination Drive to Continue Despite Safety Concerns

The Delhi High Court on Wednesday refused to stay the ongoing human papillomavirus (HPV) vaccination drive across India, after the Centre reported that only 120 adverse events had been recorded out of nearly 55.9 lakh doses administered since February.

Hearing a public interest litigation (PIL) that raised safety concerns over Merck's Gardasil vaccine, a bench of Chief Justice D K Upadhyaya and Justice Tejas Karia noted that there was 'no instant harm' from the vaccine.

The Ministry of Health and Family Welfare informed the court that as of July 25, out of 55.9 lakh doses administered, 120 cases of adverse events following immunisation (AEFI) had been reported. Of these, 42 were classified as 'serious/severe', but no deaths occurred. Causality assessment has been completed in 20 of the 42 serious cases, and none required hospitalisation beyond two days.

Additional Solicitor General Chetan Sharma and standing counsel Ashish Dixit argued that the AEFI reporting rate — approximately 0.0022% of total doses — 'is much below the normal, even FDA-considered benchmark of AEFI'.

The court remarked, '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 PIL, filed by gynaecologist Dr Sujata Mittal and health entrepreneur Jitendra Chouksey, cited past adverse events, including a 2010 incident in Andhra Pradesh where several deaths occurred during an earlier HPV vaccine trial. The petitioners also raised concerns about the lack of long-term safety data and informed consent.

The court noted that the petition raises 'serious issues' and directed the Centre to file an affidavit responding to the concerns. It also observed that proper protocols must be followed when introducing new vaccines, saying, 'In our zest, sometimes we fail to follow the necessary protocol… There may be long-term effects also. A person being vaccinated today may develop something wrong in 15 years.'

The government launched the vaccination drive in February, offering a free single dose of the quadrivalent HPV vaccine to 14-year-old girls to prevent cervical cancer. The Gardasil 9 vaccine protects against nine strains of HPV.

A 2017 report by the Global Advisory Committee on Vaccine Safety deemed the vaccine safe but noted attention on 'spurious case reports and unsubstantiated allegations'. A 2026 meta-analysis in Human Vaccines and Immunotherapeutics found serious adverse event rates ranging from 0.00 to 4.53 per 1,000 doses across 14 studies.

The court has listed the matter for further hearing after the Centre files its affidavit.