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Review| Volume 49, ISSUE 6, SUPPLEMENT 4, S364-S376, December 2015

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Enhancing Vaccine Safety Capacity Globally

A Lifecycle Perspective
      Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries.
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      References

        • Moxon E.R.
        • Das P.
        • Greenwood B.
        • Heymann D.L.
        • Horton R.
        • Levine O.S.
        • et al.
        A call to action for the new decade of vaccines.
        Lancet. 2011; 378: 298-302
        • Zipprich J.
        • Winter K.
        • Hacker J.
        • Xia D.
        • Watt J.
        • Harriman K.
        Measles outbreak – California, December 2014–February 2015.
        MMWR Morb Mort Wkl Report. 2015; 64: 153-154
        • Wakefield A.J.
        • Murch S.H.
        • Anthony A.
        • Linnell J.
        • Casson D.M.
        • Malik M.
        • et al.
        Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
        Lancet. 1998; 351: 637-641
      1. Retraction – Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
        Lancet. 2010; 375: 445
        • Taylor L.E.
        • Swerdfeger A.L.
        • Eslick G.D.
        Vaccines are not associated with autism: an evidence-based meta-analysis of case–control and cohort studies.
        Vaccine. 2014; 32: 3623-3629
        • Maglione M.A.
        • Das L.
        • Raaen L.
        • Smith A.
        • Chari R.
        • Newberry S.
        • et al.
        Safety of vaccines used for routine immunization of U.S. children: a systematic review.
        Pediatrics. 2014; 134: 325-337
        • Lieu T.A.
        • Ray G.T.
        • Klein N.P.
        • Chung C.
        • Kulldorff M.
        Geographic clusters in under immunization and vaccine refusal.
        Pediatrics. 2015; 135: 280-289
        • Gangarosa E.J.
        • Galazka A.M.
        • Wolfe C.R.
        • Phillips L.M.
        • Gangarosa R.E.
        • Miller E.
        • et al.
        Impact of anti-vaccine movements on pertussis control: the untold story.
        Lancet. 1998; 351: 356-361
        • Balinska M.A.
        Hepatitis B vaccination and French Society ten years after the suspension of the vaccination campaign: how should we raise infant immunization coverage rates?.
        J Clin Virol. 2009; 46: 202-205
        • Jegede A.S.
        What led to the Nigerian boycott of the polio vaccination campaign?.
        PLoS Med. 2007; 4: e73
        • Barker C.I.
        • Snape M.D.
        Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action.
        Lancet Infect Dis. 2014; 14: 227-238
        • Hickler B.
        • Guirguis S.
        • Obregon R.
        Vaccine Special Issue on Vaccine Hesitancy.
        Vaccine. 2015; 33: 4155-4156
        • Salmon D.A.
        • Pavia A.
        • Gellin B.
        Editors’ introduction: vaccine safety throughout the product life cycle.
        Pediatrics. 2011; 127: S1-S4
        • Chen R.T.
        • Rastogi S.C.
        • Mullen J.R.
        • Hayes S.W.
        • Cochi S.L.
        • Donlon J.A.
        • et al.
        The Vaccine Adverse Event Reporting System (VAERS).
        Vaccine. 1994; 12: 542-550
        • Lane J.M.
        • Millar J.D.
        Routine childhood vaccination against smallpox reconsidered.
        N Engl J Med. 1969; 281: 1220-1224
        • Fenner F.
        • Henderson D.A.
        • Arita I.
        • Jezek Z.
        • Ladnyi I.D.
        Smallpox and its eradication. World Health Organization, Geneva1988
        • Prevots D.R.
        • Burr R.K.
        • Sutter R.W.
        • Murphy T.V.
        • Advisory Committee on Immunization P
        Poliomyelitis prevention in the United States. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP).
        MMWR Recomm Rep. 2000; 49 (quiz CE1–7): 1-22
        • Patel M.
        • Zipursky S.
        • Orenstein W.
        • Garon J.
        • Zaffran M.
        Polio endgame: the global introduction of inactivated polio vaccine.
        Expert Rev Vaccines. 2015; 14: 749-762
        • Smith M.H.
        National childhood vaccine injury compensation act.
        Pediatrics. 1988; 82: 264-269
        • Klein N.P.
        • Bartlett J.
        • Fireman B.
        • Rowhani-Rahbar A.
        • Baxter R.
        Comparative effectiveness of acellular versus whole-cell pertussis vaccines in teenagers.
        Pediatrics. 2013; 131: e1716-e1722
      2. Recommendations of the International Task Force for Disease Eradication.
        MMWR Recomm Rep. 1993; 42: 1-38
        • Baxter P.
        Pertussis vaccine encephalopathy: ’Oh! Let us never, never doubt’….
        Dev Med Child Neurol. 2010; 52: 883-884
        • Lilienfeld D.E.
        The first pharmacoepidemiologic investigations: national drug safety policy in the United States, 1901–1902.
        Perspect Biol Med. 2008; 51: 188-198
        • Baylor N.W.
        • Marshall V.B.
        Regulation and testing of vaccines.
        in: Plotkin S.A. Orenstein W.A. Offit P.A. Vaccines. 6th ed. Saunders, Edinburgh2012: 1427-1446
        • Nunnally B.K.
        • Turula V.E.
        • Sitrin R.D.
        Vaccine analysis: strategies, principles, and control.
        1st ed. Springer, New York, NY2014
        • U.S. Food and Drug Administration (FDA). 21 CFR Part 4 [Docket No. FDA-2009-N-0435]
        Current Good Manufacturing Practice Requirements for Combination Products.
        Federal Register. 2013; : 4307-4323
        • Committee for Medicinal Product for Human Use (CHMP)
        Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines. EMA/CHMP/VWP/141697/2009 ed.
        European Medicines Agency, London2010 ([Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/08/WC500095721.pdf)
        • WHO
        WHO Expert Committee on Biological Standardization.
        World Health Organ Tech Rep Ser. 2015; : 63-87
        • Elmgren L.
        • Li X.
        • Wilson C.
        • Ball R.
        • Wang J.
        • Cichutek K.
        • et al.
        A global regulatory science agenda for vaccines.
        Vaccine. 2013; 31: B163-B175
        • U.S. Food and Drug Administration (FDA)
        CBER Strategic Plan for Regulatory Science and Research.
        2012
        • Pagliusi S.
        • Leite L.C.
        • Datla M.
        • Makhoana M.
        • Gao Y.
        • Suhardono M.
        • et al.
        Developing Countries Vaccine Manufacturers Network: doing good by making high-quality vaccines affordable for all.
        Vaccine. 2013; 31: B176-B183
        • Belgharbi L.
        • Dellapiane N.
        • Wood D.J.
        Regulation of vaccines in developing countries.
        in: Plotkin S. Orenstein W.A. Offit P.A. Vaccines. 6th ed. Saunders, Edinburgh2012: 1454-1463
        • U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research
        Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. 2007
        • Bonhoeffer J.
        • Imoukhuede E.B.
        • Aldrovandi G.
        • Bachtiar N.S.
        • Chan E.S.
        • Chang S.
        • et al.
        Template protocol for clinical trials investigating vaccines – focus on safety elements.
        Vaccine. 2013; 31: 5602-5620
        • Chen R.T.
        • Carbery B.
        • Mac L.
        • Berns K.I.
        • Chapman L.
        • Condit R.C.
        • et al.
        The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).
        Vaccine. 2015; 33: 73-75
        • Monath T.P.
        • Seligman S.J.
        • Robertson J.S.
        • Guy B.
        • Hayes E.B.
        • Condit R.C.
        • et al.
        Live virus vaccines based on a yellow fever vaccine backbone: standardized template with key considerations for a risk/benefit assessment.
        Vaccine. 2015; 33: 62-72
        • Chen R.T.
        • Glanz J.
        • Vellozzi C.
        Pharmacoepidemiology studies of vaccine safety.
        in: Strom B.L. Kimmel S.E. Hennessy S. Pharmacoepidemiology. 5th ed. Wiley-Blackwell, Chichester, West Sussex, UK2012: 423-468
        • Black S.
        Perspectives on the design and analysis of prelicensure trials: bridging the gap to postlicensure studies.
        Clin Infect Dis. 2001; 33: S323-S326
        • McNeil M.M.
        • Gee J.
        • Weintraub E.S.
        • Belongia E.A.
        • Lee G.M.
        • Glanz J.M.
        • et al.
        The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.
        Vaccine. 2014; 32: 5390-5398
        • Nguyen M.
        • Ball R.
        • Midthun K.
        • Lieu T.A.
        The Food and Drug Administration’s Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.
        Pharmacoepidemiol Drug Saf. 2012; 21: 291-297
        • LaRussa P.S.
        • Edwards K.M.
        • Dekker C.L.
        • Klein N.P.
        • Halsey N.A.
        • Marchant C.
        • et al.
        Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network.
        Pediatrics. 2011; 127: S65-S73
      3. U.S. Food and Drug Administration. Guidance for Industry: Postmarketing Studies and Clinical Trials - Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act 2011 [updated April 2011; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf.

        • Smith J.C.
        The structure, role, and procedures of the U.S. Advisory Committee on Immunization Practices (ACIP).
        Vaccine. 2010; 28: A68-A75
      4. U.S. Food and Drug Administration (FDA). Charter of the Vaccines and Related Biological Products Advisory Committee 2014 [updated January 9, 2014; cited 2015 August 11]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.htm.

      5. U.S. Food and Drug Administration (FDA). Charter of the Pediatric Advisory Committee to the Food and Drug Administration 2014 [updated September 18, 2014; cited 2015 August 11]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm116525.htm.

        • Savel T.G.
        • Foldy S.
        • Centers for Disease Control and Prevention (CDC)
        The role of public health informatics in enhancing public health surveillance.
        MMWR Surveill Summ. 2012; 61: 20-24
        • Shimabukuro T.
        The Vaccine Adverse Event Reporting System (VAERS) form Version 2.0 (proposed).
        in: National Vaccine Advisory Committee meeting September 9, 2014: National Vaccine Program Office/HHS. 2014 ([cited 2015 August 11]. Available from: http://www.hhs.gov/nvpo/nvac/meetings/upcomingmeetings/NVAC%20Meeting%20Materials/tab_7.3_shimabukuro_vaers_2_0_enote.pdf)
        • U.S. Centers for Disease Control and Prevention (CDC). [Docket No. CDC-2014-0015]
        Request for Comment on Draft Vaccine Adverse Event Reporting System (VAERS) 2.0 Form.
        Federal Register. November 24, 2014; 79: 69853-69854
        • U.S. Food and Drug Administration (FDA). 21 CFR Parts 310, 314, 329, and 600. [Docket No. FDA-2008-N-0334]. RIN 9010-AF96
        Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.
        Federal Register. 2014; 79: 33072-33092
        • U.S. Food and Drug Administration (FDA). [Docket No. FDA-2001-D-0067 (Formerly Docket No. 2001D-0185)]
        Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports.
        Federal Register. 2014; 79: 33200-33201
        • Hinrichsen V.L.
        • Kruskal B.
        • O’Brien M.A.
        • Lieu T.A.
        • Platt R.
        Using electronic medical records to enhance detection and reporting of vaccine adverse events.
        J Am Med Inform Assoc. 2007; 14: 731-735
        • Baker M.K.D.
        • Mazza M.
        • et al.
        Automated Detection and Reporting of Vaccine Adverse Events: ESP-VAERS.
        in: Adult and Pediatric Vaccines at IDWeek 2013; October 3, 2013, San Francisco, CA2013
        • Vaccine Adverse Event Reporting System (VAERS) Application for Mobile Devices
        Small Business Innovation Research/Small Business Technology Transfer.
        2013 ([cited 2015 August 11]. Available from: http://www.sbir.gov/sbirsearch/detail/679697)
        • Stockwell M.S.
        • Broder K.
        • LaRussa P.
        • Lewis P.
        • Fernandez N.
        • Sharma D.
        • et al.
        Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine.
        JAMA Pediatr. 2014; 168: 211-219
        • DuMouchel W.
        Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system.
        Am Stat. 1999; 53: 177-190
        • Szarfman A.
        • Machado S.G.
        • O’Neill R.T.
        Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA’s spontaneous reports database.
        Drug Saf. 2002; 25: 381-392
        • Martin D.
        • Menschik D.
        • Bryant-Genevier M.
        • Ball R.
        Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010–2011 seasonal influenza virus vaccine.
        Drug Saf. 2013; 36: 547-556
        • Wang X.
        • Hripcsak G.
        • Markatou M.
        • Friedman C.
        Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study.
        J Am Med Inform Assoc. 2009; 16: 328-337
        • Botsis T.
        • Buttolph T.
        • Nguyen M.D.
        • Winiecki S.
        • Woo E.J.
        • Ball R.
        Vaccine adverse event text mining system for extracting features from vaccine safety reports.
        J Am Med Inform Assoc. 2012; 19: 1011-1018
        • Baggs J.
        • Gee J.
        • Lewis E.
        • Fowler G.
        • Benson P.
        • Lieu T.
        • et al.
        The Vaccine Safety Datalink: a model for monitoring immunization safety.
        Pediatrics. 2011; 127: S45-S53
        • Lieu T.A.
        • Kulldorff M.
        • Davis R.L.
        • Lewis E.M.
        • Weintraub E.
        • Yih K.
        • et al.
        Real-time vaccine safety surveillance for the early detection of adverse events.
        Med Care. 2007; 45: S89-S95
        • McClure D.L.
        • Xu S.
        • Weintraub E.
        • Glanz J.M.
        An efficient statistical algorithm for a temporal scan statistic applied to vaccine safety analyses.
        Vaccine. 2011; 30: 3986-3991
        • Greene S.K.
        • Kulldorff M.
        • Lewis E.M.
        • Li R.
        • Yin R.
        • Weintraub E.S.
        • et al.
        Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project.
        Am J Epidemiol. 2010; 171: 177-188
        • Tse A.
        • Tseng H.F.
        • Greene S.K.
        • Vellozzi C.
        • Lee G.M.
        • Group VSDRCAIW
        Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010–2011.
        Vaccine. 2012; 30: 2024-2031
        • Gee J.
        • Naleway A.
        • Shui I.
        • Baggs J.
        • Yin R.
        • Li R.
        • et al.
        Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.
        Vaccine. 2011; 29: 8279-8284
        • Lee G.M.
        • Greene S.K.
        • Weintraub E.S.
        • Baggs J.
        • Kulldorff M.
        • Fireman B.H.
        • et al.
        H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project.
        Am J Prev Med. 2011; 41: 121-128
        • Yih W.K N.M.
        • Maro J.
        • Baker M.
        • Balsbaugh C.
        • Brown J.
        • Cole D.
        • et al.
        Mini-Sentinel Cber/Prism Methods Protocol: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine, Version 2.0.
        2015
        • HCUP
        Clinical Classifications Software: Healthcare Cost and Utilization Project (HCUP).
        Agency for Healthcare Research and Quality, Rockville, MD2015 March
        • Kulldorff M.
        TreeScan: Software for the Tree-Based Scan Statistic.
        2014 (Available from:)
        • Kulldorff M.
        • Dashevsky I.
        • Avery T.R.
        • Chan A.K.
        • Davis R.L.
        • Graham D.
        • et al.
        Drug safety data mining with a tree-based scan statistic.
        Pharmacoepidemiol Drug Saf. 2013; 22: 517-523
        • Swamy G.K.
        • Garcia-Putnam R.
        Maternal immunization to benefit the mother, fetus, and infant.
        Obstet Gynecol Clin North Am. 2014; 41: 521-534
        • Grohskopf L.A.
        • Sokolow L.Z.
        • Olsen S.J.
        • Bresee J.S.
        • Broder K.R.
        • Karron R.A.
        Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season.
        MMWR Morbidity and mortality weekly report. 2015; 64: 818-825
        • U.S. Centers for Disease Control Prevention (CDC)
        Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012.
        MMWR Morbidity and mortality weekly report. 2013; 62: 131-135
        • Keller-Stanislawski B.
        • Englund J.A.
        • Kang G.
        • Mangtani P.
        • Neuzil K.
        • Nohynek H.
        • et al.
        Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines.
        Vaccine. 2014; 32: 7057-7064
        • Bratton K.N.
        • Wardle M.T.
        • Orenstein W.A.
        • Omer S.B.
        Maternal influenza immunization and birth outcomes of stillbirth and spontaneous abortion: a systematic review and meta-analysis.
        Clin Infect Dis. 2014;
        • Kharbanda E.O.
        • Vazquez-Benitez G.
        • Lipkind H.S.
        • Klein N.P.
        • Cheetham T.C.
        • Naleway A.
        • et al.
        Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes.
        J Am Med Assoc. 2014; 312: 1897-1904
        • Rasmussen S.A.
        • Watson A.K.
        • Kennedy E.D.
        • Broder K.R.
        • Jamieson D.J.
        Vaccines and pregnancy: past, present, and future.
        Semin Fetal Neonatal Med. 2014; 19: 161-169
        • Faucette A.N.
        • Unger B.L.
        • Gonik B.
        • Chen K.
        Maternal vaccination: moving the science forward.
        Hum Reprod Update. 2015; 21: 119-135
        • U.S. Food and Drug Administration (FDA)
        Pregnancy and Lactation Labeling Final Rule. 2014 ([updated 12/04/14; cited 2015 August 11]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm)
        • U.S. Food and Drug Administration (FDA)
        Draft Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products. 2014 ([updated Dec 2014; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf)
        • Institute of Medicine (IOM)
        The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. National Academies Press, Washington (DC)2013
        • Elam-Evans L.D.
        • Yankey D.
        • Singleton J.A.
        • Kolasa M.
        • (CDC) CfDCaP
        National, state, and selected local area vaccination coverage among children aged 19–35 months – United States, 2013.
        MMWR Morb Mort Wkl Report. 2014; 63: 741-748
        • Glanz J.M.
        • Newcomer S.R.
        • Narwaney K.J.
        • Hambidge S.J.
        • Daley M.F.
        • Wagner N.M.
        • et al.
        A population-based cohort study of under vaccination in 8 managed care organizations across the United States.
        JAMA Pediatr. 2013; 167: 274-281
        • Nabel G.J.
        Designing tomorrow’s vaccines.
        N Engl J Med. 2013; 368: 551-560
        • Schijns V.E.
        • Lavelle E.C.
        Trends in vaccine adjuvants.
        Expert Rev Vaccines. 2011; 10: 539-550
        • Saroja C.
        • Lakshmi P.
        • Bhaskaran S.
        Recent trends in vaccine delivery systems: a review.
        Int J Pharm Investig. 2011; 1: 64-74
        • Prausnitz M.R.
        • Mikszta J.A.
        • Cormier M.
        • Andrianov A.K.
        Microneedle-based vaccines.
        Curr Top Microbiol Immunol. 2009; 333: 369-393
        • Czerkinsky C.
        • Cuburu N.
        • Kweon M.N.
        • Anjuere F.
        • Holmgren J.
        Sublingual vaccination.
        Hum Vaccin. 2011; 7: 110-114
        • Wanjek C.
        Systems biology as defined by NIH: an intellectual resource for integrative biology.
        NIH Catal. 2011; 19: 1-12
      6. U.S. National Institutes of Health (NIH). Talking Glossary of Genetic Terms: Personalized Medicine. National Human Genome Research Institute. Available from: http://www.genome.gov/glossary/index.cfm?id=150.

        • Kennedy R.B.
        • Poland G.A.
        The top five “game changers’’ in vaccinology: toward rational and directed vaccine development.
        OMICS. 2011; 15: 533-537
        • U.S. Food and Drug Administration (FDA)
        Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development. 2013 ([updated October 2013; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf)
        • Oberg A.L.
        • McKinney B.A.
        • Schaid D.J.
        • Pankratz V.S.
        • Kennedy R.B.
        • Poland G.A.
        Lessons learned in the analysis of high-dimensional data in vaccinomics.
        Vaccine. 2015; 33: 5262-5270
      7. Remarks by the President in State of the Union Address, January, 20, 2015. 2015. [cited 2015 August 11]. Available from: http://www.whitehouse.gov/the-press-office/2015/01/20/remarks-president-state-union-address-january-20-2015.

        • Destefano F.
        • Vellozzi C.
        Facilitators Report, Lessons learned exercise, ECDC Vaccine Adverse Event Surveillance and Communication: (VAESCO II) project.
        European Centers for Disease Control and Prevention, Stockholm2009 ([cited 2015 August 11]. Available from: http://vaesco.net/vaesco/news/extras/01/text_files/file/VAESCO%20facilitator%20report%20lessons%20learned%20fxd%20CVupdated_August312012%20.pdf)
        • Trifiro G.
        • Coloma P.M.
        • Rijnbeek P.R.
        • Romio S.
        • Mosseveld B.
        • Weibel D.
        • et al.
        Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?.
        J Intern Med. 2014; 275: 551-561
        • Dieleman J.
        • Romio S.
        • Johansen K.
        • Weibel D.
        • Bonhoeffer J.
        • Sturkenboom M.
        • et al.
        Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe.
        Br Med J. 2011; 343: d3908
        • European Centre for Disease Prevention and Control (ECDC)
        Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation.
        ECDC, Stockholm2012 ([updated September 2012; cited 2015 August 11]. Available from: http://vaesco.net/vaesco/results/main/04/text_files/file/ECDC%202012%20VAESCO%20Narco%20report%20FULL.pdf)
        • Wijnans L.
        • Lecomte C.
        • de Vries C.
        • Weibel D.
        • Sammon C.
        • Hviid A.
        • et al.
        The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns.
        Vaccine. 2013; 31: 1246-1254
        • Romio S.
        • Weibel D.
        • Dieleman J.P.
        • Olberg H.K.
        • de Vries C.S.
        • Sammon C.
        • et al.
        Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: a multinational self-controlled case series in Europe.
        PLOS ONE. 2014; 9: e82222
        • Mitchell V.
        • Dietz V.J.
        • Okwo-Bele J.M.
        • Cutts F.T.
        Immunization in developing countries.
        Vaccines. 6th ed. Elsevier Saunders, Philadelphia2013: 1369-1394
        • Mahoney R.T.
        • Maynard J.E.
        The introduction of new vaccines into developing countries.
        Vaccine. 1999; 17: 646-652
        • Kaddar M.
        • Milstien J.
        • Schmitt S.
        Impact of BRICS’ investment in vaccine development on the global vaccine market.
        Bull World Health Organ. 2014; 92: 436-446
        • Black S.
        • Zuber P.L.
        Global trends and challenges in vaccine safety.
        Pediatric Health. 2009; 3: 329-335
        • World Health Organization (WHO)
        Global Vaccine Safety Blueprint Geneva.
        Department of Immunization, Vaccines and Biologicals, 2012
      8. World Health Organization (WHO). The Global Vaccine Safety Initiative (GVSI) WHO. Available from: http://www.who.int/vaccine_safety/initiative/en/ [updated November 2014].

        • Maure C.G.
        • Dodoo A.N.
        • Bonhoeffer J.
        • Zuber P.L.
        The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level.
        Bull World Health Organ. 2014; 92: 695-696
        • World Health Organization (WHO)
        Global Vaccine Safety Initiative portfolio of activities Switzerland.
        WHO, 2013 (Available from:)
        • World Health Organization (WHO)
        Global Vaccine Safety Blueprint: The Landscape Analysis Geneva.
        Department of Immunization, Vaccines and Biologicals, 2012
        • World Health Organization (WHO)
        Strengthening national regulatory authorities.
        2012 (Available from:)
        • Diomande F.V.
        • Vannice K.S.
        • Ouandaogo C.R.
        • Keita M.
        • Djingarey M.H.
        • Mbakuliemo N.
        • et al.
        Lessons learnt from enhancing vaccine pharmacovigilance activities during MenAfriVac™ introduction in African countries, 2010 to 2013.
        CID. 2015; (in press)
        • World Health Organization (WHO)
        Global Advisory Committee on Vaccine Safety: Preparing for malaria vaccine introduction.
        Wkly Epid Rec. 2015; 90: 18-20
        • World Health Organization (WHO)
        Global Advisory Committee on Vaccine Safety: Preparing for dengue vaccine introduction.
        Wkly Epid Rec. 2015; 90: 17-28
        • The Lancet
        An Ebola vaccine: first results and promising opportunities.
        Lancet. 2015; ([Epub ahead of print](pii: S0140-6736(15)61177-1. doi: 10.1016/S0140-6736(15)61177-1.))
      9. Council for International Organizations of Medical Sciences (CIOMS), 2013. Available from: http://www.cioms.ch/.

        • Alonso P.L.
        • de Quadros C.A.
        • Robert M.
        • Lal A.A.
        Decade of vaccines. Editorial.
        Vaccine. 2013; 31: B3-B4
        • Izurieta H.S.
        • Zuber P.
        • Bonhoeffer J.
        • Chen R.T.
        • Sankohg O.
        • Laserson K.F.
        • et al.
        Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines.
        Vaccine. 2013; 31: 3623-3627
      10. Indepth Network, Better Health Information for Better Health Policy, Available from: http://www.indepth-network.org/.

        • Dodd C.N.
        • Romio S.A.
        • Black S.
        • Vellozzi C.
        • Andrews N.
        • Sturkenboom M.
        • et al.
        International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.
        Vaccine. 2013; 31: 4448-4458
        • Black S.
        • Mulholland K.
        • Halsey N.A.
        Developing sustainable funding for vaccine safety infrastructure.
        Vaccine. 2010; 28: 1133-1134
        • U.S. National Institutes of Health (NIH)
        The Jordan report: accelerated development of vaccines 2012.
        NIH, NIAID, 2012 (NIH publication no. 11-7778)
        • Rappuoli R.
        • Pizza M.
        • Del Giudice G.
        • De Gregorio E.
        Vaccines, new opportunities for a new society.
        Proc Natl Acad Sci U S A. 2014; 111: 12288-12293
        • Andre F.E.
        • Booy R.
        • Bock H.L.
        • Clemens J.
        • Datta S.K.
        • John T.J.
        • et al.
        Vaccination greatly reduces disease, disability, death and inequity worldwide.
        Bull World Health Organ. 2008; 86: 140-146
        • Ellenberg S.S.
        • Foulkes M.A.
        • Midthun K.
        • Goldenthal K.L.
        Evaluating the safety of new vaccines: summary of a workshop.
        Am J Public Health. 2005; 95: 800-807
        • Gowda C.
        • Dempsey A.F.
        The rise (and fall?) of parental vaccine hesitancy.
        Hum Vaccines Immunother. 2013; 9: 1755-1762
        • Fine P.E.
        • Clarkson J.A.
        Individual versus public priorities in the determination of optimal vaccination policies.
        Am J Epidemiol. 1986; 124: 1012-1020
        • Francois G.
        • Duclos P.
        • Margolis H.
        • Lavanchy D.
        • Siegrist C.A.
        • Meheus A.
        • et al.
        Vaccine safety controversies and the future of vaccination programs.
        Pediatr Infect Dis J. 2005; 24: 953-961
        • Dube E.
        • Laberge C.
        • Guay M.
        • Bramadat P.
        • Roy R.
        • Bettinger J.
        Vaccine hesitancy: an overview.
        Hum Vaccines Immunother. 2013; 9: 1763-1773
        • Seeff L.B.
        • Beebe G.W.
        • Hoofnagle J.H.
        • Norman J.E.
        • Buskell-Bales Z.
        • Waggoner J.G.
        • et al.
        A serologic follow-up of the 1942 epidemic of post-vaccination hepatitis in the United States Army.
        N Engl J Med. 1987; 316: 965-970
        • Nathanson N.
        • Langmuir A.D.
        The cutter incident, poliomyelitis following formaldehyde- inactivated poliovirus vaccination in the United States during the spring of 1955. I. Background.
        Am J Hygiene. 1963; 78: 16-28
        • Nathanson N.
        • Langmuir A.D.
        The cutter incident, poliomyelitis following formaldehyde- inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to cutter vaccine.
        Am J Hygiene. 1963; 78: 29-60
        • Offit P.A.
        The Cutter incident, 50 years later.
        N Engl J Med. 2005; 352: 1411-1412
        • Wilson G.S.
        The hazards of immunization.
        Athlone P, London1967: 324
        • Schonberger L.B.
        • Bregman D.J.
        • Sullivan-Bolyai J.Z.
        • Keenlyside R.A.
        • Ziegler D.W.
        • Retailliau H.F.
        • et al.
        Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977.
        Am J Epidemiol. 1979; 110: 105-123
        • Zhou W.
        • Pool V.
        • Iskander J.K.
        • English-Bullard R.
        • Ball R.
        • Wise R.P.
        • et al.
        Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) – United States, 1991–2001.
        MMWR Surveill Summ. 2003; 52: 1-24
        • Stetler H.C.
        • Mullen J.R.
        • Brennan J.P.
        • Livengood J.R.
        • Orenstein W.A.
        • Hinman A.R.
        Monitoring system for adverse events following immunization.
        Vaccine. 1987; 5: 169-174
        • Faich G.A.
        Adverse-drug-reaction monitoring.
        N Engl J Med. 1986; 314: 1589-1592
        • Niu M.T.
        • Erwin D.E.
        • Braun M.M.
        Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination.
        Vaccine. 2001; 19: 4627-4634
        • Bonhoeffer J.
        • Kohl K.
        • Chen R.
        • Duclos P.
        • Heijbel H.
        • Heininger U.
        • et al.
        The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI).
        Vaccine. 2002; 21: 298-302
        • Chen R.T.
        • Glasser J.W.
        • Rhodes P.H.
        • Davis R.L.
        • Barlow W.E.
        • Thompson R.S.
        • et al.
        Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team.
        Pediatrics. 1997; 99: 765-773
        • Ball L.K.
        • Evans G.
        • Bostrom A.
        Risky business: challenges in vaccine risk communication.
        Pediatrics. 1998; 101: 453-458
        • Gust D.A.
        • Gangarosa P.
        • Hibbs B.
        • Pollard R.
        • Wallach G.
        • Chen R.T.
        National Immunization Information Hotline: Calls concerning adverse events, 1998–2000.
        J Health Commun. 2004; 9: 387-394
      11. Howson C.P. Howe C.J. Fineberg H.V. Adverse Effects of Pertussis and Rubella Vaccines: A Report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. National Academy Press, Washington (DC)1991
      12. Stratton K.R. Howe C.J. Johnston R.B. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. National Academy Press, Washington (DC)1994
        • Institute of Medicine (IOM)
        Immunization Safety Review 2001–2004: National Academy Press (US).
        2004 ([updated 7/24/2013; cited 2015 August 11]. Available from: http://www.iom.edu/activities/publichealth/immunizationsafety.aspx)
      13. Stratton K. Ford A. Rusch E. Clayton E.W. Adverse Effects of Vaccines: Evidence and Causality. National Academy Press, Washington (DC)2011
        • Farrington P.
        • Pugh S.
        • Colville A.
        • Flower A.
        • Nash J.
        • Morgan-Capner P.
        • et al.
        A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines.
        Lancet. 1995; 345: 567-569
        • Hviid A.
        Post licensure epidemiology of childhood vaccination: the Danish experience.
        Expert Rev Vaccines. 2006; 5: 641-649
        • Pasternak B.
        • Feenstra B.
        • Melbye M.
        • Hviid A.
        Improving vaccine safety through a better understanding of vaccine adverse events.
        Clin Infect Dis. 2015;
        • Dourado I.
        • Cunha S.
        • Teixeira M.G.
        • Farrington C.P.
        • Melo A.
        • Lucena R.
        • et al.
        Outbreak of aseptic meningitis associated with mass vaccination with a urabe-containing measles-mumps-rubella vaccine: implications for immunization programs.
        Am J Epidemiol. 2000; 151: 524-530
        • Freitas D.R.
        • Moura E.
        • Araujo G.
        • Cardoso A.
        • Scheidt P.
        • Ferraz E.
        • et al.
        Investigation of an outbreak of hypersensitivity-type reactions during the 2004 national measles-mumps-rubella vaccination campaign in Brazil.
        Vaccine. 2013; 31: 950-954
        • Ouandaogo C.R.
        • Yameogo T.M.
        • Diomande F.V.
        • Sawadogo C.
        • Ouedraogo B.
        • Ouedraogo-Traore R.
        • et al.
        Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010.
        Vaccine. 2012; 30: B46-B51
        • Hutin Y.J.
        • Chen R.T.
        Injection safety: a global challenge.
        Bull World Health Organ. 1999; 77: 787-788
        • Ali M.
        • Canh G.D.
        • Clemens J.D.
        • Park J.K.
        • von Seidlein L.
        • Minh T.T.
        • et al.
        The use of a computerized database to monitor vaccine safety in Viet Nam.
        Bull World Health Organ. 2005; 83: 604-610
        • Pool V.
        • Braun M.M.
        • Kelso J.M.
        • Mootrey G.
        • Chen R.T.
        • Yunginger J.W.
        • et al.
        Prevalence of anti-gelatin IgE antibodies in people with anaphylaxis after measles-mumps rubella vaccine in the United States.
        Pediatrics. 2002; 110: e71
        • Kramarz P.
        • DeStefano F.
        • Gargiullo P.M.
        • Davis R.L.
        • Chen R.T.
        • Mullooly J.P.
        • et al.
        Does influenza vaccination exacerbate asthma? Analysis of a large cohort of children with asthma. Vaccine Safety Datalink Team.
        Arch Fam Med. 2000; 9: 617-623
        • Ball R.
        • Shadomy S.V.
        • Meyer A.
        • Huber B.T.
        • Leffell M.S.
        • Zachary A.
        • et al.
        HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination.
        Arthritis Rheum. 2009; 60: 1179-1186
        • White O.J.
        • McKenna K.L.
        • Bosco A.
        • HJvdB A.
        • Richmond P.
        • Holt P.G.
        A genomics-based approach to assessment of vaccine safety and immunogenicity in children.
        Vaccine. 2012; 30: 1865-1874
        • Kaslow R.A.
        • Sullivan-Bolyai J.Z.
        • Hafkin B.
        • Schonberger L.B.
        • Kraus L.
        • Moore M.J.
        • et al.
        HLA antigens in Guillain-Barre syndrome.
        Neurology. 1984; 34: 240-242