Anaphylaxis following quadrivalent human papillomavirus

Julia M.L. Brotherton MD MPH, Mike S. Gold MD, Andrew S. Kemp MD PhD, Peter B. McIntyre MD PhD, Margaret A. Burgess MD, Sue Campbell-Lloyd RN, on behalf of the New South Wales Health HPV Adverse Events Panel

Background:

In 2007, Australia implemented the National human papillomavirus (HPV) Vaccination Program, which provides quadrivalent HPV vaccine free to all women aged 12–26 years. Following notification of 7 presumptive cases of anaphylaxis in the state of New South Wales, Australia, we verified cases and compared the incidence of anaphylaxis following HPV vaccination to other vaccines in comparable settings.

Methods:

We contacted all patients with suspected anaphylaxis and obtained detailed histories from telephone interviews and a review of medical records. A multidisciplinary team determined whether each suspected case met the standardized Brighton definition. Some participants also received skin-prick allergy testing for common antigens and components of the HPV vaccine.

Results:

Of 12 suspected cases, 8 were classified as anaphylaxis. Of these, 4 participants had negative skin-prick test results for intradermal Gardasil. From the 269 680 HPV vaccine doses administered in schools, 7 cases of anaphylaxis were identified, which represents an incidence rate of 2.6 per 100 000 doses (95% CI 1.0–5.3 per 100 000). In comparison, the rate of identified anaphylaxis was 0.1 per 100 000 doses (95% CI 0.003–0.7) for conjugated meningococcal C vaccination in a 2003 school-based program.

Interpretation:

Based on the number of confirmed cases, the estimated rate of anaphylaxis following quadrivalent HPV vaccine was significantly higher than identified in comparable school-based delivery of other vaccines. However, overall rates were very low and managed appropriately with no serious sequelae.

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[Note from SaneVax:  An anaphylactic reaction rate at 2.6/100,000 doses is equivalent to 7.8 reactions per 100,000 persons if everyone receives 3 doses of Gardasil. In Connecticut the cervical cancer rate is probably lower than 6 per 100,000 women, most in women who were not screened by regular Pap. Since anaphylaxis carries a risk of immediate death and permanent injuries, the immediate risks exceed the potential cancer prevention, a benefit which is not even proven in clinical trials.]