Gardasil "remarkably safe," despite anaphylaxis

Gardasil is "remarkably safe," according to a new study by Australian researchers published in the Canadian Medical Association Journal, even though the study found that the receiving the vaccine meant girls had between a five and 20 times higher risk of developing allergic reactions compared to other vaccines. The drug has been approved in the United States since 2006.

Twelve in the sample of 114,000 Australian girls and women had an anaphylactic reaction during the study period, and eight of those had received the vaccination. The rate anaphylaxis was 2.6 per 100,000 doses (269,680 doses given), which compares unfavorably to a rate of 0.1 per 100,000 doses seen in the C-conjugate meningitis vaccine. Gardasil aims to prevent some of the strains of human papilloma virus (HPV), which is often associated with later development of cervical cancer.

The researchers admitted the rate of serious allergic reactions is much higher for Gardasil than for other vaccinations that children receive and while the girls received prompt treatment, the reactions were potentially serious and could have been life threatening.

As with any medication or vaccine, a thorough risk-benefit analysis is always a smart idea. Patients should consider the immediate risk of contracting HPV, allergies, side effect profile, Pap smear compliance, cost and tolerance to pain before deciding on the Gardasil vaccine.

The Journal of the American Medical Association's editor-in-chief, Pediatrician Catherine DeAngelis, does not give the vaccine carte blanche, saying that we don't yet know how long the vaccine will last or what the true risks are down the road.

- check out the Washington Post article
- read the U.S. News & World Report article
- here is what PharmaTimes says
- see the CMAJ study

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