Reactions 1475, p4 - 26 Oct 2013 No new safety concerns with quadrivalent HPV vaccine Among females, the administration of quadrivalent human papillomavirus (HPV) vaccine was not associated with any new safety concerns with respect to autoimmune, neurological and venous thromboembolic events, according to findings of a large retrospective study. 1 The investigators conducted a registry based cohort study in 997 585 girls aged 10–17 years in Denmark and Sweden, over a 4-year period, to assess the risk of serious adverse events up to 180 days following vaccination with the quadrivalent HPV vaccine (53 different outcomes). Overall, 296 826 (29.8%) girls received at least one dose of the vaccine. Among the vaccinated girls, 80.4% received a second dose and 54.2% received three doses. Quadrivalent HPV vaccine was not associated with serious autoimmune, neurological and venous thromboembolic events. Of note, exposure to the vaccine was associated with increased risks of Behcet’s syndrome (rate ratio 3.37; 95% CI 1.0, 1.80), Raynaud’s disease (1.67; 1.14, 2.44), and type 1 diabetes mellitus (1.29; 1.03, 1.62). However, no causal associations were found. In an accompanying editorial, Dr Julia Brotherton, comments that "this new evidence firmly indicates that concern about vaccine related adverse events is not a rational reason to forgo this potentially lifesaving vaccine." 2 1. Arnheim-Dahlstr¨ om L, et al. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ 347: f5906 [11 pages], 9 Oct 2013. Available from: URL: http:// dx.doi.org/10.1136/bmj.f5906. 2. Brotherton JML. Safety of the quadrivalent human papillomavirus vaccine. BMJ 347: f5631 [2 pages], 9 Oct 2013. Available from: URL: http:// dx.doi.org/10.1136/bmj.f5631. 803094573 1 Reactions 26 Oct 2013 No. 1475 0114-9954/13/1475-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved

No new safety concerns with quadrivalent HPV vaccine

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Reactions 1475, p4 - 26 Oct 2013

No new safety concerns withquadrivalent HPV vaccine

Among females, the administration of quadrivalenthuman papillomavirus (HPV) vaccine was not associatedwith any new safety concerns with respect toautoimmune, neurological and venous thromboembolicevents, according to findings of a large retrospectivestudy.1

The investigators conducted a registry based cohortstudy in 997 585 girls aged 10–17 years in Denmark andSweden, over a 4-year period, to assess the risk ofserious adverse events up to 180 days followingvaccination with the quadrivalent HPV vaccine (53different outcomes). Overall, 296 826 (29.8%) girlsreceived at least one dose of the vaccine. Among thevaccinated girls, 80.4% received a second dose and54.2% received three doses.

Quadrivalent HPV vaccine was not associated withserious autoimmune, neurological and venousthromboembolic events. Of note, exposure to thevaccine was associated with increased risks of Behcet’ssyndrome (rate ratio 3.37; 95% CI 1.0, 1.80), Raynaud’sdisease (1.67; 1.14, 2.44), and type 1 diabetes mellitus(1.29; 1.03, 1.62). However, no causal associationswere found.

In an accompanying editorial, Dr Julia Brotherton,comments that "this new evidence firmly indicates thatconcern about vaccine related adverse events is not arational reason to forgo this potentially lifesavingvaccine."2

1. Arnheim-Dahlstrom L, et al. Autoimmune, neurological, and venousthromboembolic adverse events after immunisation of adolescent girls withquadrivalent human papillomavirus vaccine in Denmark and Sweden: cohortstudy. BMJ 347: f5906 [11 pages], 9 Oct 2013. Available from: URL: http://dx.doi.org/10.1136/bmj.f5906.

2. Brotherton JML. Safety of the quadrivalent human papillomavirus vaccine. BMJ347: f5631 [2 pages], 9 Oct 2013. Available from: URL: http://dx.doi.org/10.1136/bmj.f5631.

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