Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review

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.

Conocimientos sobre el virus del papiloma humano y su vacuna en padres de familia de Rivera, Huila en el 2015

“…La mayoría de las reacciones adversas que genera la vacuna son locales, como dolor, enrojecimiento y fiebre, rara vez de tipo sistémicas graves [9][10][11] . Desde el 2007, distintos países del mundo reportaron una serie de supuestos efectos adversos tras su aplicación, destacándose la afectación del sistema nervioso central 9,12 .Para septiembre del año 2015 se habían reportado 37474 informes de eventos adversos de vacunas, 3119 reacciones adversas y 16 muertes relacionadas con Cervarix® 13 .En Colombia durante el 2014, más de 300 niñas del municipio Carmen de Bolívar manifestaron presentar eventos secundarios luego de la aplicación de la segunda dosis de la vacuna, evento difundido masivamente por medios de comunicación 14 .…”

Adverse events following school-based vaccination of girls with quadrivalent human papillomavirus vaccine in Slovenia, 2009 to 2013

“…The most common AEFI was injectionrelated local reaction [8,9]. Fever, nausea, vomiting, dizziness, myalgia and diarrhoea were the most commonly reported systemic symptoms [8,10,11].…”

El Carmen de Bolívar: una lección que no debemos olvidar

“…De esta forma, y a partir de la evidencia disponible, podemos concluir que comparada frente al grupo control, la administración de la vacuna para el VPH parece no incrementar la frecuencia de efectos adversos serios (3) pero sí la de efectos adversos menores locales y sistémicos (4). Ahora bien, al abordar la hipótesis de la respuesta psicógena masiva y luego de revisar algunos artículos disponibles, no resulta para nada lejano recordar lo ocurrido al interior del municipio De El Carmen de Bolívar.…”