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Safety, tolerability and side effects of human papillomavirus vaccines: A systematic quantitative review
6th Euro Global Summit and Expo on Vaccines & Vaccination
August 17-19, 2015 Birmingham, UK

Ana Katherine Gonçalves1, Cobucci RN2, Rodrigues HM2, de Melo AG2 and Giraldo PC3

Scientific Tracks Abstracts: J Vaccines Vaccin

Abstract:

Recently, many studies have evaluated HPV vaccine safety and adverse effects. Two vaccines have been recently evaluated in
randomized controlled trials: The bivalent vaccine for HPV 16 and 18 (Cervarix, GlaxoSmithKline Biologicals, Rixensart,
Belgium) and the quadrivalent vaccine for HPV 6, 11, 16, and 18 (Gardasil, Merck and Co., Inc., Whitehouse Station, NJ).
We have performed a systematic review of all randomized controlled trials in which HPV vaccines were compared with
placebo regarding safety, tolerability and adverse effects. Studies were searched up to March 2013 in the databases: Pubmed,
Embase, Scielo and Cancerlit. Odds Ratios (OR) of most incident adverse effects were obtained. Twelve reports, involving
29,540 subjects, were included. In the HPV 16/18 group, the most frequently reported events related to the vaccine were pain
(OR 3.29; 95% CI: 3.00-3.60), swelling (OR 3.14; 95% CI: 2.79-3.53) and redness (OR 2.41; 95% CI: 2.17-2.68). For the HPV
6/11/16/18 group the events were pain (OR 2.88; 95% CI: 2.42-3.43) and swelling (OR 2.65; 95% CI: 2.0-3.44). Concerning
the HPV 16/18 vaccine, pain was the most common outcome detected. These effects can be due to a possible VLP-related
inflammation process. Fatigue was the most relevant general effect observed followed by fever, gastrointestinal symptoms, and
headache. In the HPV 6/11/16/18 group, only general symptoms, pain and swelling were observed. Pain and swelling were
the most frequent. Comparing HPV 16/18 to HPV 6/11/16/18 vaccines, the former presented more adverse effects, perhaps
because there are many more trials evaluating the bivalent vaccine. Other studies are needed to clarify this issue.

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