Human papilloma virus vaccines and current controversy.

I fully agree with the views expressed by the authors [1] as far as the role of HPV vaccine in prevention of cervical cancer is concerned. I also agree that the vaccine is safe, devoid of any serious side effects, ethical, and socially desirable. But will it be legally safe to use this vaccine? When the authors have themselves agreed that suspending clinical trial while allowing clinical use is illogical, it does not require to be a legal luminary to conclude that when even the clinical trial of a drug/vaccine is suspended, its clinical use will not only be illogical but illegal too. Will the arguments given by them be valid in a court of law in case of any mishap after this vaccination, which may or may not be related to this vaccine. Every court is going to rule that when even clinical trial was suspended how clinical use can be justified. Moreover, as per media reports, which may or may not be correct, DGHS, Government of India has written to health ministers of all states not to use this vaccine till further orders (The Hindu 8th April, 2010). Therefore, I feel that one should not use this vaccine till the enquiry is finally over and the government clears this vaccine for all purposes. Please specify the official views of Indian Academy of Pediatrics regarding the legality of this vaccine, for the benefit of all members of IAP, especially practitioners. REPLY Dr Singhal's main concern is the legal safety in using the Human Papillomavirus (HPV) vaccine in view of the suspension of studies with this vaccine. It is beyond our jurisdiction to opine on judicial matters, but we strongly feel that the concern is unfounded. Studies in question relate to administration of HPV vaccine which seeks to determine vaccine coverage achieved, feasibility, acceptability of HPV vaccination, and implementation costs associated with different vaccination strategies in a variety of socioeconomic settings. Such studies may be put on hold for variety of reasons. The HPV vaccines used in these studies are commercially available in India and approved by the Drug Controller General of India (DCGI), US Food and Drug Administration (FDA) and European Medicines Agency. The two HPV vaccines used in the project have been prequalified by WHO. The vaccines continue to remain as a licensed product approved by the DCGI. On safety issue, the WHO position paper on HPV vaccines …