Quadrivalent HPV vaccine safety review and safety monitoring plans for nine-valent HPV vaccine in the United States

References

• Bonanni P, Cohet C, Kjaer SK, Latham NB, Lambert PH, Reisinger K, Haupt RM. A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD. Vaccine 2010; 28:4719-30; PMID:20451636; http://dx.doi.org/10.1016/j.vaccine.2010.04.070
   PubMed Web of Science ®Google Scholar
• Petrosky E, Bocchini JA, Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, Unger ER, Markowitz LE, Centers for Disease C, Prevention. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep 2015; 64:300-4; PMID:25811679
   PubMed Web of Science ®Google Scholar
• Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, Package Insert. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM11 1263.pdf
   Google Scholar
• Human Papillomavirus Bivalent (types 16 and 18) Vaccine, Recombinant, Package Insert. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf
   Google Scholar
• Human Papillomavirus 9-valent Vaccine, Recombinant, Package Insert. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf
   Google Scholar
• Agorastos T, Chatzigeorgiou K, Brotherton JM, Garland SM. Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Vaccine 2009; 27:7270-81; PMID:19799849; http://dx.doi.org/10.1016/j.vaccine.2009.09.097
   PubMed Web of Science ®Google Scholar
• Macartney KK, Chiu C, Georgousakis M, Brotherton JM. Safety of Human Papillomavirus Vaccines: A Review. Drug Saf 2013; PMID:23637071
   PubMed Web of Science ®Google Scholar
• Markowitz LE, Hariri S, Unger ER, Saraiya M, Datta SD, Dunne EF. Post-licensure monitoring of HPV vaccine in the United States. Vaccine 2010; 28:4731-7; PMID:20188681; http://dx.doi.org/10.1016/j.vaccine.2010.02.019
   PubMed Web of Science ®Google Scholar
• Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK, Sings HL, Perez G, Haupt RM, Saah AJ, et al. An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015. Pediatr Infect Dis J 2015; 34:983-91; PMID:26107345; http://dx.doi.org/10.1097/INF.0000000000000793
   PubMed Web of Science ®Google Scholar
• Darden PM, Thompson DM, Roberts JR, Hale JJ, Pope C, Naifeh M, Jacobson RM. Reasons for not vaccinating adolescents: National Immunization Survey of Teens, 2008–2010. Pediatrics 2013; 131:645-51; PMID:23509163; http://dx.doi.org/10.1542/peds.2012-2384
   PubMed Web of Science ®Google Scholar
• Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, MacNeil J, Markowitz LE, Stokley S. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years–United States, 2014. MMWR Morb Mortal Wkly Rep 2015; 64:784-92; PMID:26225476; http://dx.doi.org/10.15585/mmwr.mm6429a3
   PubMed Web of Science ®Google Scholar
• DeStefano F. The Vaccine Safety Datalink project. PharmacoepidemiolDrug Saf 2001; 10:403-6; http://dx.doi.org/10.1002/pds.613
   PubMed Web of Science ®Google Scholar
• Sukumaran L. Human Papillomavirus (HPV) Vaccine Safety Update. Presented at Advisory Committee on Immunization Practices Meeting October 2015. Available at: http://www.cdc.gov/vaccines/acip/meetings/slides-2015-10.html
   Google Scholar
• Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302:750-7; PMID:19690307; http://dx.doi.org/10.1001/jama.2009.1201
   PubMed Web of Science ®Google Scholar
• Stokley S, Jeyarajah J, Yankey D, Cano M, Gee J, Roark J, Curtis RC, Markowitz L. Immunization Services Division NCfI, Respiratory Diseases CDC, et al. Human papillomavirus vaccination coverage among adolescents, 2007–2013, and postlicensure vaccine safety monitoring, 2006–2014–United States. MMWR Morb Mortal Wkly Rep 2014; 63:620-4; PMID:25055185
   PubMed Web of Science ®Google Scholar
• Stokley SCC, Jeyarajah J, et al. Human Papillomavirus Vaccination Coverage Among Adolescent Girls, 2007–2012, and Postlicensure Vaccine Safety Monitoring, 2006–2013 — United States. MMWR Recomm Rep 2013; 62(29);591-595
   Web of Science ®Google Scholar
• Frequently asked questions about HPV Vaccine Safety. Available at: http://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html
   Google Scholar
• Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (WONDER) search tool for the Vaccine Adverse Event Reporting System (VAERS). Available at: http://wonder.cdc.gov/vaers.html
   Google Scholar
• Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, Kulldorff M, Lewis E, Fireman B, Daley MF, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011; 29:8279-84; PMID:21907257; http://dx.doi.org/10.1016/j.vaccine.2011.08.106
   PubMed Web of Science ®Google Scholar
• McNeil MM, Weintraub ES, Duffy J, Sukumaran L, Jacobsen SJ, Klein NP, Hambidge SJ, Lee GM, Jackson LA, Irving SA, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol 2015; PMID:26452420
   PubMed Web of Science ®Google Scholar
• Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med 2012; 166:1140-8; PMID:23027469; http://dx.doi.org/10.1001/archpediatrics.2012.1451
   PubMed Web of Science ®Google Scholar
• Della Corte C, Carlucci A, Francalanci P, Alisi A, Nobili V. Autoimmune hepatitis type 2 following anti-papillomavirus vaccination in a 11-year-old girl. Vaccine 2011; 29:4654-6; PMID:21596082; http://dx.doi.org/10.1016/j.vaccine.2011.05.002
   PubMed Web of Science ®Google Scholar
• Pellegrino P, Carnovale C, Perrone V, Antoniazzi S, Pozzi M, Clementi E, Radice S. Can HPV immunisation cause ADEM? Two case reports and literature review. Mult Scler 2014; 20:762-3; PMID:23970503; http://dx.doi.org/10.1177/1352458513502114
   PubMed Web of Science ®Google Scholar
• Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology 2009; 72:2132-3; PMID:19528522; http://dx.doi.org/10.1212/WNL.0b013e3181aa53bb
   PubMed Web of Science ®Google Scholar
• DeStefano F, Weintraub ES, Chen RT. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study. Neurology 2005; 64:1317; PMID:15832457
   PubMed Web of Science ®Google Scholar
• Siegrist CA. Autoimmune diseases after adolescent or adult immunization: what should we expect? CMAJ 2007; 177:1352-4; PMID:18025425; http://dx.doi.org/10.1503/cmaj.071134
   PubMed Web of Science ®Google Scholar
• Siegrist CA, Lewis EM, Eskola J, Evans SJ, Black SB. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. PediatrInfectDisJ 2007; 26:979-84
   Google Scholar
• Jacobsen SJ, Sy LS, Ackerson BK, Chao CR, Slezak JM, Cheetham TC, Takhar HS, Velicer CM, Hansen J, Klein NP. An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women. Vaccine 2012; 30:4585-7; PMID:22580356; http://dx.doi.org/10.1016/j.vaccine.2012.04.103
   PubMed Web of Science ®Google Scholar
• Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. JInternMed 2012; 271:193-203
   Web of Science ®Google Scholar
• Grimaldi-Bensouda L, Guillemot D, Godeau B, Benichou J, Lebrun-Frenay C, Papeix C, Labauge P, Berquin P, Penfornis A, Benhamou PY, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med 2014; 275:398-408; PMID:24206418; http://dx.doi.org/10.1111/joim.12155
   PubMed Web of Science ®Google Scholar
• Arnheim-Dahlstrom L, Pasternak B, Svanstrom H, Sparen P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ 2013; 347:f5906; PMID:24108159; http://dx.doi.org/10.1136/bmj.f5906
   PubMed Web of Science ®Google Scholar
• Scheller NM, Svanstrom H, Pasternak B, Arnheim-Dahlstrom L, Sundstrom K, Fink K, Hviid A. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA 2015; 313:54-61; PMID:25562266; http://dx.doi.org/10.1001/jama.2014.16946
   PubMed Web of Science ®Google Scholar
• Little DT, Ward HR. Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination. BMJ Case Rep 2012; 2012:bcr2012006879; PMID:23035167
   PubMedGoogle Scholar
• Little DT, Ward HR. Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice. J Investig Med High Impact Case Rep 2014; 2:2324709614556129; PMID:26425627
   PubMedGoogle Scholar
• Dragojevic-Dikic S, Marisavljevic D, Mitrovic A, Dikic S, Jovanovic T, Jankovic-Raznatovic S. An immunological insight into premature ovarian failure (POF). Autoimmun Rev 2010; 9:771-4; PMID:20601203; http://dx.doi.org/10.1016/j.autrev.2010.06.008
   PubMed Web of Science ®Google Scholar
• Santoro N. Mechanisms of premature ovarian failure. Ann Endocrinol (Paris) 2003; 64:87-92; PMID:12773939
   PubMed Web of Science ®Google Scholar
• Yan G, Schoenfeld D, Penney C, Hurxthal K, Taylor AE, Faustman D. Identification of premature ovarian failure patients with underlying autoimmunity. J Womens Health Gend Based Med 2000; 9:275-87; PMID:10787223; http://dx.doi.org/10.1089/152460900318461
   PubMedGoogle Scholar
• Scheller NM, Pasternak B, Svanstrom H, Hviid A. Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism. JAMA 2014; 312:187-8; PMID:25005658; http://dx.doi.org/10.1001/jama.2014.2198
   PubMed Web of Science ®Google Scholar
• Naleway AL, Crane B, Smith N, Daley MF, Donahue J, Gee J, Greene SK, Harrington T, Jackson LA, Klein NP, et al. Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink 2008–2011. Vaccine 2016; 34(1):167-71
   PubMed Web of Science ®Google Scholar
• Yih WK, Greene SK, Zichittella L, Kulldorff M, Baker MA, Jong JL, Gil-Prieto R, Griffin MR, Jin R, Lin ND, et al. Evaluation of the risk of venous thromboembolism after quadrivalent human papillomavirus vaccination among US females. Vaccine 2016; 34(1):172-8; PMID:26549364
   PubMed Web of Science ®Google Scholar
• Sotiriadis A, Dagklis T, Siamanta V, Chatzigeorgiou K, Agorastos T, Group LS. Increasing fear of adverse effects drops intention to vaccinate after the introduction of prophylactic HPV vaccine. Arch Gynecol Obstet 2012; 285:1719-24; PMID:22246478; http://dx.doi.org/10.1007/s00404-011-2208-z
   PubMed Web of Science ®Google Scholar
• European Medicines Agency recommends continued vaccination with Gardasil. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/11/WC500011828.pdf
   Google Scholar
• Hanley SJ, Yoshioka E, Ito Y, Kishi R. HPV vaccination crisis in Japan. Lancet 2015; 385:2571; PMID:26122153; http://dx.doi.org/10.1016/S0140-6736(15)61152-7
   PubMed Web of Science ®Google Scholar
• Richards S, Chalkiadis G, Lakshman R, Buttery JP, Crawford NW. Complex regional pain syndrome following immunisation. Arch Dis Child 2012; 97:913-5; PMID:22858647; http://dx.doi.org/10.1136/archdischild-2011-301307
   PubMed Web of Science ®Google Scholar
• Weinbaum CCM. HPV Vaccination and Complex Regional Pain Syndrome: Lack of Evidence. EBioMed 2015; 2:1014-5; http://dx.doi.org/10.1016/j.ebiom.2015.08.030
   PubMed Web of Science ®Google Scholar
• Tomljenovic L, Colafrancesco S, Perricone C, Shoenfeld Y. Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants:” Case Report and Literature Review. J Investig Med High Impact Case Rep 2014; 2:2324709614527812; PMID:26425598
   PubMedGoogle Scholar
• Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine 2015; 33:2602-5; PMID:25882168; http://dx.doi.org/10.1016/j.vaccine.2015.03.098
   PubMed Web of Science ®Google Scholar
• Grubb BP. Postural tachycardia syndrome. Circulation 2008; 117:2814-7; PMID:18506020; http://dx.doi.org/10.1161/CIRCULATIONAHA.107.761643
   PubMed Web of Science ®Google Scholar
• Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, et al. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res 2011; 21:69-72; PMID:21431947; http://dx.doi.org/10.1007/s10286-011-0119-5
   PubMed Web of Science ®Google Scholar
• Review concludes evidence does not support that HPV vaccines cause CRPS or POTS. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2015/11/WC500196352.pdf
   Google Scholar
• Cancer vaccine girl died of malignant chest tumor. Medical News Today, 2009 Available at: http://wwwmedicalnewstodaycom/articles/165961php
   Google Scholar
• Medical examiner: Girl's death not caused by HPV vaccination, Journal Sentinal, 2014. Available at: http://www.jsonline.com/news/health/medical-examiner-girls-death-not-caused-by-routine-vaccination-b99376029z1-280058462.html
   Google Scholar
• McCarthy NL, Gee J, Sukumaran L, Weintraub E, Duffy J, Kharbanda EO, Baxter R, Irving S, King J, Daley MF, et al. Vaccination and 30-day mortality risk in children, adolescents, and young adults. Pediatrics 2016; 137(3):1-8.
   Web of Science ®Google Scholar
• Hoyert DL, Xu J. Deaths: preliminary data for 2011. National vital statistics reports : from the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System 2012; 61:1-51
   PubMedGoogle Scholar
• Markowitz LE, Dunne EF, Saraiya M, Chesson HW, Curtis CR, Gee J, Bocchini JA, Jr, Unger ER, Centers for Disease C, Prevention. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014; 63:1-30; PMID:25167164
   PubMed Web of Science ®Google Scholar
• Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, et al. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol 2009; 114:1179-88; http://dx.doi.org/10.1097/AOG.0b013e3181c2ca21
   PubMed Web of Science ®Google Scholar
• Goss MA, Lievano F, Buchanan KM, Seminack MM, Cunningham ML, Dana A. Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine. Vaccine 2015; 33:3422-8; PMID:25869893; http://dx.doi.org/10.1016/j.vaccine.2015.04.014
   PubMed Web of Science ®Google Scholar
• Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, Broder K. Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006–2013. Vaccine 2015; 33:519-22; PMID:25500173; http://dx.doi.org/10.1016/j.vaccine.2014.11.047
   PubMed Web of Science ®Google Scholar
• Levin MJ, Moscicki AB, Song LY, Fenton T, Meyer WA, 3rd, Read JS, Handelsman EL, Nowak B, Sattler CA, Saah A, et al. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr 2010; 55:197-204; PMID:20574412; http://dx.doi.org/10.1097/QAI.0b013e3181de8d26
   PubMed Web of Science ®Google Scholar
• Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, et al. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis 2010; 202:1246-53; PMID:20812850; http://dx.doi.org/10.1086/656320
   PubMed Web of Science ®Google Scholar
• Kojic EM, Kang M, Cespedes MS, Umbleja T, Godfrey C, Allen RT, Firnhaber C, Grinsztejn B, Palefsky JM, Webster-Cyriaque JY, et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis 2014; 59:127-35; PMID:24723284; http://dx.doi.org/10.1093/cid/ciu238
   PubMed Web of Science ®Google Scholar
• Kahn JA, Xu J, Kapogiannis BG, Rudy B, Gonin R, Liu N, Wilson CM, Worrell C, Squires KE. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis 2013; 57:735-44; PMID:23667266; http://dx.doi.org/10.1093/cid/cit319
   PubMed Web of Science ®Google Scholar
• Giacomet V, Penagini F, Trabattoni D, Vigano A, Rainone V, Bernazzani G, Bonardi CM, Clerici M, Bedogni G, Zuccotti GV. Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults. Vaccine 2014; 32:5657-61; PMID:25149430; http://dx.doi.org/10.1016/j.vaccine.2014.08.011
   PubMed Web of Science ®Google Scholar
• Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis 2014; 209:1165-73; PMID:24273179; http://dx.doi.org/10.1093/infdis/jit657
   PubMed Web of Science ®Google Scholar
• Wilcox AJ, Weinberg CR, O'Connor JF, Baird DD, Schlatterer JP, Canfield RE, Armstrong EG, Nisula BC. Incidence of early loss of pregnancy. N Engl J Med 1988; 319:189-94; PMID:3393170; http://dx.doi.org/10.1056/NEJM198807283190401
   PubMed Web of Science ®Google Scholar
• Iskander JK, Miller ER, Chen RT. The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety. PediatrAnn 2004; 33:599-606
   Google Scholar
• Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004; 23:287-94; PMID:15071280; http://dx.doi.org/10.1097/00006454-200404000-00002
   PubMed Web of Science ®Google Scholar
• Baggs J, Gee J, Lewis E, Fowler G, Benson P, Lieu T, Naleway A, Klein NP, Baxter R, Belongia E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety. Pediatrics 2011; 127 Suppl 1:S45-S53; http://dx.doi.org/10.1542/peds.2010-1722H
   PubMed Web of Science ®Google Scholar
• Lieu TA, Kulldorff M, Davis RL, Lewis EM, Weintraub E, Yih K, Yin R, Brown JS, Platt R. Real-time vaccine safety surveillance for the early detection of adverse events. MedCare 2007; 45:S89-S95
   PubMed Web of Science ®Google Scholar
• Woodcock J. Another important step in FDA's journey towards enhanced safety through full-scale “active surveillance.” Available at: http://blogs.fda.gov/fdavoice/index.php/2014/12/another-important-step-in-fdas-journey-towards-enhanced-safety-through-full-scale-act ive-surveillance/
   Google Scholar
• Findlay S. Health Policy Brief: The FDA's Sentinel Initiative. Available at: http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_139.pdf
   Google Scholar
• Sentinel Initiative Public Workshop, 2016. Available at: http://healthpolicy.duke.edu/files/2016/03/8th-Annual-Sentinel-Public-Workshop-Slide-Deck-Edit.pdf
   Google Scholar
• Approval Letter - Gardasil 9, 2014. Available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm426520.htm
   Google Scholar
• Gollust SE, Attanasio L, Dempsey A, Benson AM, Fowler EF. Political and news media factors shaping public awareness of the HPV vaccine. Womens Health Issues 2013; 23:e143-51; PMID:23557851; http://dx.doi.org/10.1016/j.whi.2013.02.001
   PubMed Web of Science ®Google Scholar
• Institute of Medicine of the National Academies. Adverse events: evidence and causality Washington, DC: The National Academies Press; 2011
   Google Scholar
• Global Advisory Committe On Vaccine safety Statement on Safety of HPV vaccines, 2015. Available at: http://www.who.int/vaccine_safety/committee/GACVS_HPV_statement_17Dec2015.pdf?ua=1. 2015
   Google Scholar
• Global Advisory Committee on Vaccine Safety statement on the continued safety of HPV vaccination, 2014. Available at: http://www.who.int/vaccine_safety/committee/topics/hpv/GACVS_Statement_HPV_12_Mar_2014.pdf
   Google Scholar