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.