Benefits and harms of the human papillomavirus (HPV) vaccines: systematic review with meta-analyses of trial data from clinical study reports
Abstract
Objective To assess the benefits and harms of the human papillomavirus (HPV) vaccines. Data sources Clinical study reports obtained from the European Medicines Agency and GlaxoSmithKline from 2014 to 2017. Eligibility criteria Randomised trials that compared an HPV vaccine with a placebo or active comparator in healthy participants of all ages. Appraisal and synthesis Two researchers extracted data and judged risk of bias with the Cochrane tool (version 2011). Risk ratio (RR) estimates were pooled using random-effects meta-analysis. Outcomes Clinically relevant outcomes in intention to treat populations—including HPV-related cancer precursors irrespective of involved HPV types, treatment procedures and serious and general harms. Results Twenty-four of 50 eligible clinical study reports were obtained with 58,412 pages of 22 trials and 2 follow-up studies including 95,670 participants: 79,102 females and 16,568 males age 8–72; 393,194 person-years; and 49 months mean weighted follow-up. We judged all 24 studies to be at high risk of bias. Serious harms were incompletely reported for 72% of participants (68,610/95,670). Nearly all control participants received active comparators (48,289/48,595, 99%). No clinical study report included complete case report forms. At 4 years follow-up, the HPV vaccines reduced HPV-related carcinoma in situ (367 in the HPV vaccine group vs. 490 in the comparator group, RR 0.73 [95% confidence interval, CI, 0.53 to 1.00], number needed to vaccinate…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 95,670 participants or records.
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