Letters
Women's health
Volume 189 - Issue 9

"I want the one for older women" — extending the human papillomavirus vaccine population base

Authors:  Helen S Marshall and David Isaacs

Med J Aust 2008; 189 (9): 526-528. || doi: 10.5694/j.1326-5377.2008.tb02157.x
Published online: 3 November 2008
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To the Editor: We would like to express our disappointment with the Journal’s decision to publish an editorial on human papillomavirus (HPV) vaccines that demonstrated significant bias.1 It seems that simply documenting an author’s conflicts of interest exonerates the author and relieves the Journal of the responsibility of considering whether or not the article is biased.

In his article, Wain states that the bivalent vaccine, Cervarix (GlaxoSmithKline), has not been included in the National Immunisation Program, having initially been rejected by the Pharmaceutical Benefits Advisory Committee (PBAC) on the grounds of uncertain cost-effectiveness. He omits to mention that Gardasil (Merck), was initially also rejected, and only funded after political intervention, an emergency meeting of the PBAC and further price negotiations with CSL.2

Wain claims that Cervarix is being promoted to older women despite the absence of efficacy data and the uncertain population benefits in this age group. Surely a balanced argument would include the fact that Gardasil is licensed for boys aged from 9–15 years based on immunogenicity data only, and that efficacy has not been established in this population. Why does the author consider this to be acceptable, but that licensing the vaccine for older women where the indication is to prevent cervical cancer is unacceptable? Many vaccines are licensed on the basis of immunogenicity data provided these have been shown to predict efficacy. While the efficacy of HPV vaccines in older women is being established, there are good data to show that an immune response to HPV vaccine is predictive of efficacy.3 Women aged over 26 years produce a robust immune response to HPV vaccines, similar to levels achieved in women aged 15–25 years, for whom efficacy has already been demonstrated. The Therapeutic Goods Administration has licensed Cervarix for women aged 26–45 years, before efficacy data became available, based on the assumption that efficacy will be demonstrated in seronegative older women.

Women of all ages have shown interest in benefiting from a vaccine to protect against cervical cancer.4 Women of any age have the right to be informed, and to have the opportunity to discuss with their treating physician the relative benefits and risks of receiving the HPV vaccine for prevention of cervical cancer.

Many vaccines are initially available only if purchased by individuals and, although this may result in inequity, ultimately, this is a decision of priority (individual financial and public health funding priorities) and not a reason to withhold licensing a vaccine with proven benefit.

Authors

  • Helen S Marshall1
  • David Isaacs2
  • 1. Department of Paediatrics, Women’s and Children’s Hospital, Adelaide, SA.
  • 2. The Children’s Hospital at Westmead, Sydney, NSW.

Correspondence: helen.marshall@adelaide.edu.au

Competing interests

Helen Marshall is a member of a CSL Gardasil Advisory Board; has been a principal investigator for clinical vaccine studies sponsored by both CSL and GlaxoSmithKline; and has received travel assistance to present scientific data at international meetings.

References

View this article on Wiley Online Library