Human papilloma virus vaccination in males: A pharmacovigilance study on the Vaccine Adverse Event Reporting System. Issue 4 (3rd November 2020)

• Record Type: Journal Article
• Authors: Bonaldo, Giulia; Montanaro, Nicola; Vaccheri, Alberto; Motola, Domenico
• Is Part Of: British journal of clinical pharmacology. Volume 87:Issue 4(2021)
• Page Start: 1912
• Page End: 1917
• Publication Date: 2020-11-03
• Subjects: human papilloma virus -- males -- safety -- vaccine -- vaccinovigilance; Pharmacology -- Periodicals; Drugs -- Periodicals; 615.1
• DOI: 10.1111/bcp.14584
• Languages: English
• ISSNs: 0306-5251

Abstract

Abstract : Aims: Human papilloma virus (HPV) is 1 of the most common sexually transmitted infection responsible for different types of cancer: cervical, penile, vulvar, anal and oropharyngeal. It can affect both males and females. Our aim was to enrich the knowledge on the safety profiles of HPV vaccines in the male population. Methods: We reviewed all the reports of adverse events following immunization (AEFI) present in the US Vaccine Adverse Event Reporting System from 1 January 2006 to 30 September 2018. Statistical data mining was performed using the reporting odds ratio with 95% confidence interval in order to detect disproportionality in reporting. Results: A total of 5493 reports of AEFI were retrieved. The events most reported and that proportionally occurred more frequently with HPV vaccines than with others in males were: syncope ( n = 701, reporting odds ratio = 2.85, 95% confidence interval [1.41–5.76p), loss of consciousness ( n = 425, 2.79 [1.36–5.72]) and fall ( n = 272, 3.54 [2.00–6.26]). Conclusion: Most of the AEFIs were already reported in premarketing clinical trials and acknowledged for the corresponding vaccines. A disproportionate reporting was found for some of these events including syncope. The HPV vaccines are generally well tolerated in males, although limitations own of spontaneous reporting should be considered.