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correspondence

Indian Pediatr 2011;48: 248-249

Reply


Panna Choudhury and Vijay Yewale

IAP Committee on Immunization.
Email: [email protected]  
 


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 states that, "in clinical trials, mild and transient local reactions at the site of injection (erythema, pain, or swelling) were 10-20% more frequent among those who received the current HPV vaccines than in their respective control groups, but no systemic adverse reactions assessed to be causally associated with the HPV immunization have been reported" [1].  To date, no deaths have been causally associated with HPV vaccination in India or elsewhere. A joint report of Center for Disease Control and Prevention (CDC) and FDA  analyzed adverse events following HPV vaccine administration from June 2006 through December 2008. The report found that after more than 23 million doses were administered nationally, vast majority (94%) of adverse events reported after receiving this vaccine has not been serious. Reported deaths with available records, autopsy reports, or death certificates describe causes other than recent vaccination [2].

Suspension of the study does not equal withdrawal of the license to use it and there is no case to suspend the use of the vaccine in individual practice.

References

1. WHO. Weekly Epidemiological Record. 2009; 84: 117-32. From:http://www.who.int/wer/2009/wer8415.pdf. Accessed on 29 October, 2010.

2. Slade BA, Leidel L, Vellozi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302:750-7.
 

 

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