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Summary What is known and background:  The introduction of vaccines has lead to a significant reduction in morbidity and mortality from diseases such as measles, rubella and poliomyelitis, as well as the eradication of smallpox (Ertl HC, Xiang Z (1996) The Journal of Immunology, 156, 3579–3582). A recent vaccine approved by the Food and Drug Administration (FDA) is the recombinant quadrivalent human papillomavirus (HPV) vaccine (Merck, Gardasil®). Concerns raised with this preventive measure include safety and efficacy issues as well as the financial implications. Furthermore, the use of the vaccine in women outside the currently approved age ranges and in adolescent boys and men has also been a source of debate. Objective:  A review of two licensed HPV vaccines (Gardasil, Merck and Cervarix, GalxoSmithKline) in the light of these issues. Methods:  Literature searches were conducted using the MEDLINE (1966 – December 2008) and PubMed databases in addition to the Centers for Disease Control and Prevention website. Bibliographies of selected references were also evaluated for relevant articles. Published guidelines and press releases were utilized as were the manufacturer’s package inserts. The collection of information for this review was limited to the most recently available human data. Results and discussion:  The HPV quadrivalent vaccine has been effective in the management of HPV by preventing vaccine subtype‐related persistent infection and precancerous lesions as evidenced by numerous clinical trials. It is also regarded as a generally safe and well‐tolerated vaccine, based on an assessment of reported adverse events submitted through governmental databases and analyzed by independent researchers. The majority of adverse events were non‐serious and the vaccine has not been conclusively implicated with serious events. The FDA continues to focus on routine post‐marketing surveillance monitoring of reported adverse events. The bivalent vaccine has also been shown to be effective in reported trials. Its adverse effect profile also appears acceptable. What is new and conclusion:  The HPV vaccines appear safe and effective. Additional clinical research on the vaccines on women outside the currently approved age ranges and in males is necessary. Studies on longer‐term outcomes, including cervical cancer and the emergence of new viral genotypes are also necessary.

ABSTRACT. Objectives. The use of complementary and alternative medicine (CAM) has grown substantially in North America and has drawn the attention of conventional-medicine practitioners. Conventional-medicine practitioners have expressed concern about the potential for unregulated CAM therapies to cause harm, the sometimes-uncertain cost-benefit ratios associated with these therapies, and the possibility that some CAM providers might advise against established conventional therapies, such as vaccination. These concerns are heightened with respect to the pediatric use of CAM products. To address this issue, we conducted a systematic audit of pediatric and adolescent case files at a large, college-based, Canadian naturopathic teaching clinic. We specifically sought to describe the demographic characteristics, reasons for presentation, use of CAM products, and vaccinations status of children presenting for naturopathic assessment. We also determined factors associated with the use of CAM products and vaccination status.Methods. We identified all charts for children (<18 years of age) who presented to the Robert Schad Naturopathic Clinic, the teaching clinic of the Canadian College of Naturopathic Medicine, between February 1 and May 31, 2002. Data were abstracted directly from the standardized patient intake forms and from clinical notes recorded during the patient's initial visit to the clinic. The following data were obtained: age, gender, chief presenting complaints reported by parents, CAM product use at presentation, vaccination status, and reactions to vaccination. We conducted logistic regression analyses to identify factors associated with both CAM product use and vaccination status.Results. A total of 482 charts were identified. The mean age of patients was 6.5 years (95% confidence interval [CI]: 1.6 -11.4 years). The ratio of female subjects to male subjects was 1.09:1 (248:227). The most common reasons for presentation were skin disorders (23%), gastrointestinal complaints (17%), and psychiatric/behavioral disorders (15%). Thirty-five percent of children were using CAM products at presentation (21.2% when both vitamins and minerals were excluded). Vitamins were the most commonly used products (34.6%), followed by herbal remedies (14.9%), oil blends/fats (7.2%), minerals (5.6%), probiotics (4.5%), and homeopathic remedies (3.7%). Of charts with vaccination information, 8.9% indicated that children had not been vaccinated; possible vaccine-associated adverse events were reported for 27% of those who had been vaccinated.