Table 3.
Human papilloma virus vaccines safety reviews.
| Author | Title | Year of publication | Type of study | Place | Population | Vaccine type | Results | |
|---|---|---|---|---|---|---|---|---|
| AE | SAE | |||||||
| Weber et al. [42] | Childhood vaccination-associated adverse events by sex: A literature review | 2014 | Review | 12 studies | HPV16/18 and HPV6/11/16/18 | The most frequent local adverse event was injection-site pain, the incidence of adverse events did not increase with increasing number of doses | No specific safety concern identified except for the Gee et al. [64] observation of an elevated risk of 1.98 for venous thromboembolism | |
| Macartney et al. [41] | Safety of human papillomavirus vaccines: a review | 2013 | Review | / | / | HPV16/18 and HPV6/11/16/18 | Injection-site adverse reaction (especially pain) and mild self-limited systemic symptoms (such as myalgia and headache) occur commonly after vaccination and should be anticipated. Some of these symptoms are more common in bHPVv | Consistent with the findings of the review no evidence supported an association of HPV vaccine with other outcomes, such new onset chronic diseases |
| Block et al. [43] | Clinical trial and post-licensure safety profile of a prophylactic Human Papillomavirus (types 6, 11, 16 and 18) L1 virus-like particle vaccine | 2010 | Review of five clinical trials | / | 21,480 girls and boys | HPV6/11/16/18 | Pain, the most common injection-site AE, occurred more frequently with vaccine (81% vaccine; 75% placebo aluminum; 45% placebo-saline). No differences were seen in the incidence of the most common non-serious AEs–headache and pyrexia | SAE occurred in 0.05% in vaccine group ad in 0.02% in placebo group. Of 18 deaths (0.1% vaccine; 0.1% placebo), all were considered unrelated to study treatment. New medical conditions which were potentially consistent with autoimmune phenomena were reported in 2.4% of both vaccine and placebo recipients |
| Agorastos et al. [40] | Safety of human papillomavirus (HPV) vaccines: A review of the international experience so far | 2009 | Review based on national and international agencies | US, Canada, Australia, Europe, Germany, France, UK | HPV6/11/16/18 and HPV16/18 | Pre-licensure data: Injection site symptoms were the most reported symptoms in one of the studies they were reported more frequently in the vaccine group than in the control group. General symptoms was slightly higher in the vaccine group | Almost all the case-reports of SAE had weak or moderate strength of evidence for causality | |
AE: Adverse event; bHPVv: Bivalent HPV vaccine; SAE: Serious adverse event.